niacinamide and Bone Neoplasms

niacinamide has been researched along with Bone Neoplasms in 61 studies

nicotinamide : A pyridinecarboxamide that is pyridine in which the hydrogen at position 3 is replaced by a carboxamide group.

Bone Neoplasms: Tumors or cancer located in bone tissue or specific BONES.

Research

Studies (61)

Authors

Clinical Trials (19)

Trial Overview

Trial Outcomes

Clinical Benefit Rate

Clinical benefit rate is defined as complete response, partial response, or stable disease (CR/PR/SD) as measured by Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for a minimum of at least 24 weeks. (NCT00525161)
Timeframe: 24 weeks

Time to Progression

(NCT00525161)
Timeframe: continuously

Response Rate

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. Patients were followed monthly for clinical and toxicity evaluation. Disease response by RECIST criteria v1.0 was assessed after 3 months by appropriate scans and these were obtained every 2 months thereafter until progression. (NCT00525161)
Timeframe: 12 weeks after treatment & 8 weeks after initial documentation of response

Apparent Oral Clearance (CL/F) of Axitinib

Clearance (CL) of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed (F). Clearance is defined as the volume of blood from which drug can be completely removed per unit of time. CL/F for steady-state axitinib was evaluated on Cycle 2 Day 15. (NCT00835978)
Timeframe: C2D15: pre-dose, 0.5, 1, 2, 4, and 6 hours post-dose

Apparent Volume of Distribution During the Elimination Phase (Vz/F) for Axitinib

Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Vz/F is influenced by the fraction absorbed. Vz/F for steady-state axitinb was evaluated on Cycle 2 Day 15. (NCT00835978)
Timeframe: C2D15: pre-dose, 0.5, 1, 2, 4, and 6 hours post-dose

Area Under the Curve From Time Zero to 24 Hours[AUC(0-24)] for Axitinib

Area under the plasma concentration time-curve from zero 24 hours[AUC(0-24). AUC(0-24) for steady-state axitinib was evaluated on Cycle 2 Day 15. Results were normalized to axitinib 7 mg dose for active titration arm and axitinib 5 mg dose for placebo titration arm. (NCT00835978)
Timeframe: C2D15: pre-dose, 0.5, 1, 2, 4, and 6 hours post-dose

Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for Axitinib

Area under the plasma concentration time-curve from zero to the last measurable concentration (AUClast). AUClast for steady-state axitinib was evaluated on Cycle 2 Day 15. Results were normalized to axitinib 7 mg dose for active titration arm and axitinib 5 mg dose for placebo titration arm. (NCT00835978)
Timeframe: C2D15: pre-dose, 0.5, 1, 2, 4, and 6 hours post-dose

Duration of Response (DR)

DR was defined as the time from the first documentation of objective tumor response (complete response - CR or Partial response - PR) to the first documentation of objective tumor progression or to death due to any cause, whichever occurred first. The median values were estimated based on Kaplan-Meier method. 95% confidence interval was based on the Brookmeyer and Crowley method. (NCT00835978)
Timeframe: Baseline up to disease progression, death, or withdrawal; performed at baseline and repeated every 8 weeks for 24 weeks, then every 12 weeks

Maximum Observed Plasma Concentration (Cmax) of Axitinib

Cmax for steady-state axitinib was evaluated on Cycle 2 Day 15. Results were normalized to axitinib 7 mg dose for active titration arm and axitinib 5 mg dose for placebo titration arm. Results were normalized to axitinib 7 mg dose for active titration arm and axitinib 5 mg dose for placebo titration arm. (NCT00835978)
Timeframe: Cycle 2 Day 15 (C2D15): pre-dose, 0.5, 1, 2, 4, and 6 hours post-dose

Objective Response Rate (ORR) - Percentage of Participants With Objective Response

ORR was defined as the proportion of participants with objective response based assessment of complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST v1.0). CR was defined as complete disappearance of all target lesions and non-target disease. No new lesions. PR was defined as >=30% decrease on study under baseline of the sum of longest diameters of all target lesions. No unequivocal progression of non-target disease. No new lesions. (NCT00835978)
Timeframe: Baseline up to disease progression, death, or withdrawal; performed at baseline and repeated every 8 weeks for 24 weeks, then every 12 weeks.

Overall Survival (OS)

OS was defined as the time from date of the first dose of the study medication to date of death due to any cause. For participants who did not die, their survival times were to be censored at the last date they were known to be alive. (NCT00835978)
Timeframe: Baseline up to disease progression, death, or withdrawal; performed at baseline and repeated every 8 weeks for 24 weeks, then every 12 weeks.

Plasma Decay Half-Life (t1/2) for Axitinib

Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. Plasma decay half life for steady-state axitinib was evaluated on Cycle 2 Day 15. (NCT00835978)
Timeframe: C2D15: pre-dose, 0.5, 1, 2, 4, and 6 hours post-dose

Progression-Free Survival (PFS)

The time from first dose administration to first documentation of objective tumor progression or to death due to any cause. PFS in each arm was assessed using the Kaplan-Meier method and estimates of the PFS curves from the Kaplan-Meier method were presented. (NCT00835978)
Timeframe: Baseline up to disease progression, death, or withdrawal; performed at baseline and repeated every 8 weeks for 24 weeks, then every 12 weeks.

Time to Reach Maximum Observed Plasma Concentration (Tmax) for Axitinib,

Tmax for steady-state axitinib was evaluated on Cycle 2 Day 15. (NCT00835978)
Timeframe: C2D15: pre-dose, 0.5, 1, 2, 4, and 6 hours post-dose

Change From Baseline in Diastolic Blood Pressure

Value at respective visit minus value at baseline. (NCT00835978)
Timeframe: At screening (D-14 to D-1); lead-in period: Cycle 1 - Day 1 and Day 15; Cycle 2 - Day 1 and Day 15; Cycle 3 & subsequent cycles Day 1; end of study and follow-up 28 days after last dose.

Change From Baseline in Systolic Blood Pressure

Value at respective visit minus value at baseline (NCT00835978)
Timeframe: At screening (D-14 to D-1); lead-in period: Cycle 1 - Day 1 and Day 15; Cycle 2 - Day 1 and Day 15; Cycle 3 & subsequent cycles Day 1; end of study and follow-up 28 days after last dose.

Circulating Endothelial Cells (CECs) in Blood: CD31+/CD146+

CECs are noninvasive marker of vascular damage, remodeling, and dysfunction. Samples were collected and following proteins were analyzed: CD31+/CD146+ CECs, CD31+/CD146+ MFI PDGFR-beta, CD31+/CD146+ MFI pPDGFR-beta, CD31+/CD146+ pVEGFR, CD31+/CD146+ MFI VEGFR. The ratio of plasma levels of the biomarkers at the selected time point vs baseline is reported. (NCT00835978)
Timeframe: At baseline - Beginning of the lead-in period (Cycle 1 Day 1)

Comparison of Circulating Endothelial Cells (CECs) in Blood: Cluster of Differentiation (CD)146+/CD105+ at Baseline

CECs are noninvasive marker of vascular damage, remodeling, and dysfunction. Samples were collected and following proteins were analyzed: CD146+/CD105+ CECs, CD146+/CD105+ mean fluorescence intensity (MFI) platelet derived growth factor receptor (PDGFR)-beta, CD146+/CD105+ MFI phospho-PDGFR (pPDGFR)-beta, CD146+/CD105+ phospho-Vascular endothelial growth factor receptor (pVEGFR), CD146+/CD105+ MFI VEGFR. The ratio of plasma levels of the biomarkers at the selected time point vs baseline is reported. (NCT00835978)
Timeframe: At baseline - Beginning of the lead-in period (Cycle 1 Day 1)

Comparison of Ratio of CECs in Blood: CD31+/CD146+ at Each Time Point to Baseline

CECs are noninvasive marker of vascular damage, remodeling, and dysfunction. Samples were collected and following proteins were analyzed: CD31+/CD146+ CECs, CD31+/CD146+ MFI PDGFR-beta, CD31+/CD146+ MFI pPDGFR-beta, CD31+/CD146+ pVEGFR, CD31+/CD146+ MFI VEGFR. The ratio of plasma levels of the biomarkers at the selected time point vs baseline is reported. (NCT00835978)
Timeframe: At end of the lead-in period (Cycle 1 Day 15), Cycle 2 Day 15 and End of therapy (EOT)

Comparison of the Ratio of CECs in Blood: CD146+/CD105+ at Each Time Point to Baseline

CECs are noninvasive marker of vascular damage, remodeling, and dysfunction. Samples were collected and following proteins were analyzed: CD146+/CD105+ CECs, CD146+/CD105+ MFI platelet derived growth factor receptor (PDGFR)-beta, CD146+/CD105+ MFI phospho-PDGFR (pPDGFR)-beta, CD146+/CD105+ phospho-VEGFR (pVEGFR), CD146+/CD105+ MFI VEGFR. The ratio of plasma levels of the biomarkers at the selected time point vs baseline is reported. (NCT00835978)
Timeframe: At end of the lead-in period (Cycle 1 Day 15), Cycle 2 Day 15 and End of therapy (EOT)

ORR in Subgroups That Were Defined by Vascular Endothelial Growth Factor A (VEGFA) or Vascular Endothelial Growth Factor Receptor 3 (VEGFR3) Polymorphisms

ORR, defined as proportion of participants with CR or PR according to RECIST, in subgroups that were defined by VEGFA or VEGFR3 polymorphisms. (NCT00835978)
Timeframe: At baseline - Beginning of the lead-in period (Cycle 1 Day 1)

PFS in Subgroups That Were Defined by Vascular Endothelial Growth Factor A (VEGFA) or Vascular Endothelial Growth Factor Receptor 3 (VEGFR3) Polymorphisms

PFS, defined as the time from randomization to first documentation of objective tumor progression or to death due to any cause, in subgroups that were defined by VEGFA or VEGFR3 polymorphisms. Estimates of the PFS curves from the Kaplan-Meier method were presented. (NCT00835978)
Timeframe: At baseline - Beginning of the lead-in period (Cycle 1 Day 1)

Duration of Response (DR): First-Line Participants

Time in months from the first documentation of objective tumor response that is subsequently confirmed to objective tumor progression or death due to any cause. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to any cause minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 30.4. DR was calculated for the subgroup of participants with a confirmed objective tumor response. (NCT00920816)
Timeframe: Baseline until disease progression or death (assessed on Week 6, Week 12 and thereafter every 8 weeks up to Week 107)

Duration of Response (DR): Second-Line Participants

Time in months from the first documentation of objective tumor response that is subsequently confirmed to objective tumor progression or death due to any cause. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to any cause minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 30.4. DR was calculated for the subgroup of participants with a confirmed objective tumor response. (NCT00920816)
Timeframe: Baseline until disease progression or death (assessed on Week 6, Week 12 and thereafter every 8 weeks up to Week 103)

Overall Survival (OS): First-Line Participants

Time in months from date of randomization to date of death due to any cause. OS was calculated as (the death date minus the date of randomization plus 1) divided by 30.4. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death). (NCT00920816)
Timeframe: Baseline until death (assessed on Week 6, Week 12 and thereafter every 8 weeks up to Week 107)

Overall Survival (OS): Second-Line Participants

Time in months from date of randomization to date of death due to any cause. OS was calculated as (the death date minus the date of randomization plus 1) divided by 30.4. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death). (NCT00920816)
Timeframe: Baseline until death (assessed on Week 6, Week 12 and thereafter every 8 weeks up to Week 103)

Percentage of Participants With Objective Response (OR): First-Line Participants

Percentage of participants with OR based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST. Confirmed response were those that persisted on repeat imaging study at least 4 weeks after initial documentation of response. CR was defined as disappearance of all lesions (target and/or non target). PR were those with at least 30 percent decrease in sum of the longest dimensions of target lesions taking as a reference the baseline sum longest dimensions, with non target lesions not increased or absent. (NCT00920816)
Timeframe: Baseline until disease progression or death (assessed on Week 6, Week 12 and thereafter every 8 weeks up to Week 107)

Percentage of Participants With Objective Response (OR): Second-Line Participants

Percentage of participants with OR based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST. Confirmed response were those that persisted on repeat imaging study at least 4 weeks after initial documentation of response. CR was defined as disappearance of all lesions (target and/or non target). PR were those with at least 30 percent decrease in sum of the longest dimensions of target lesions taking as a reference the baseline sum longest dimensions, with non target lesions not increased or absent. (NCT00920816)
Timeframe: Baseline until disease progression or death (assessed on Week 6, Week 12 and thereafter every 8 weeks up to Week 103)

Progression Free Survival (PFS): First-Line Participants

"Time in months from randomization to first documentation of objective tumor progression or death due to any cause. PFS calculated as (first event date minus date of randomization plus 1)/30.4. Tumor progression determined from oncologic assessment data (where it meets criteria for progressive disease [PD]), or from adverse event (AE) data (where outcome was Death). Progression using Response Evaluation Criteria in Solid Tumors (RECIST) is >= 20 percent (%) increase in sum of longest diameter of target lesions; measurable increase in non-target lesion; appearance of new lesions." (NCT00920816)
Timeframe: Baseline until disease progression or death (assessed on Week 6, Week 12 and thereafter every 8 weeks up to Week 107)

Progression Free Survival (PFS): Second-Line Participants

"Time in months from randomization to first documentation of objective tumor progression or death due to any cause. PFS calculated as (first event date minus date of randomization plus 1)/30.4. Tumor progression determined from oncologic assessment data (where it meets criteria for progressive disease [PD]), or from adverse event (AE) data (where outcome was Death). Progression using Response Evaluation Criteria in Solid Tumors (RECIST) is >= 20 percent (%) increase in sum of longest diameter of target lesions; measurable increase in non-target lesion; appearance of new lesions." (NCT00920816)
Timeframe: Baseline until disease progression or death (assessed on Week 6, Week 12 and thereafter every 8 weeks up to Week 103)

Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Index Score: First-Line Participants

"EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state." (NCT00920816)
Timeframe: Baseline (Pre-dose on Cycle [C]1 Day [D]1), D1 of each cycle until C23, end of treatment (up to Week 107), follow-up (28 days after last dose)

Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Index Score: Second-Line Participants

"EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state." (NCT00920816)
Timeframe: Baseline (Pre-dose on Cycle [C]1 Day [D]1), D1 of each cycle until C21, end of treatment (up to Week 103), follow-up (28 days after last dose)

Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Visual Analog Scale (VAS): First-Line Participants

EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0: worst imaginable health state to 100: best imaginable health state; higher scores indicate a better health state. (NCT00920816)
Timeframe: Baseline (Pre-dose on Cycle [C]1 Day [D]1), D1 of each cycle until C23, end of treatment (up to Week 107), follow-up (28 days after last dose)

Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Visual Analog Scale (VAS): Second-Line Participants

EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0: worst imaginable health state to 100: best imaginable health state; higher scores indicate a better health state. (NCT00920816)
Timeframe: Baseline (Pre-dose on Cycle [C]1 Day [D]1), D1 of each cycle until C21, end of treatment (up to Week 103), follow-up (28 days after last dose)

Functional Assessment of Cancer Therapy Kidney Symptom Index -Disease Related Symptoms (FKSI-DRS): First-Line Participants

FKSI-DRS: subset of FKSI which is FACT-Kidney Symptom Index questionnaire used to assess QoL for participants diagnosed with renal cell cancer. FKSI contains 15 questions and FKSI-DRS 9 questions (lack of energy, pain, losing weight, bone pain, fatigue, short of breath, coughing, bothered by fevers, hematuria) each ranging from 0 (not at all) to 4 (very much). FKSI-DRS total score 0 to 36; higher scores associated with better health states (Individual questions may be reversed coded, as appropriate). (NCT00920816)
Timeframe: Baseline (Pre-dose on Cycle [C]1 Day [D]1), D1 of each cycle until C23, end of treatment (up to Week 107), follow-up (28 days after last dose)

Functional Assessment of Cancer Therapy Kidney Symptom Index -Disease Related Symptoms (FKSI-DRS): Second-Line Participants

FKSI-DRS: subset of FKSI which is FACT-Kidney Symptom Index questionnaire used to assess QoL for participants diagnosed with renal cell cancer. FKSI contains 15 questions and FKSI-DRS 9 questions (lack of energy, pain, losing weight, bone pain, fatigue, short of breath, coughing, bothered by fevers, hematuria) each ranging from 0 (not at all) to 4 (very much). FKSI-DRS total score 0 to 36; higher scores associated with better health states (Individual questions may be reversed coded, as appropriate). (NCT00920816)
Timeframe: Baseline (Pre-dose on Cycle [C]1 Day [D]1), D1 of each cycle until C21, end of treatment (up to Week 103), follow-up (28 days after last dose)

Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15): First-Line Participants

FKSI-15 questionnaires (lack of energy, side effects, pain, weight loss, bone pain, fatigue, enjoying life, short of breath, worsened condition, appetite, coughing, bothered by fevers, ability to work, hematuria, sleep) was used to assess quality of life (QoL) for those diagnosed with renal cell cancer. Questions answered on 5-point Likert scale: 0 to 4 (0= not at all, 1= little bit, 2= somewhat, 3= quite a bit, 4= very much). Total FKSI score 0 to 60; higher scores=better health states (Individual questions may be reversed coded, as appropriate). (NCT00920816)
Timeframe: Baseline (Pre-dose on Cycle [C]1 Day [D]1), D1 of each cycle until C23, end of treatment (up to Week 107), follow-up (28 days after last dose)

Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15): Second-Line Participants

FKSI-15 questionnaires (lack of energy, side effects, pain, weight loss, bone pain, fatigue, enjoying life, short of breath, worsened condition, appetite, coughing, bothered by fevers, ability to work, hematuria, sleep) was used to assess quality of life (QoL) for those diagnosed with renal cell cancer. Questions answered on 5-point Likert scale: 0 to 4 (0= not at all, 1= little bit, 2= somewhat, 3= quite a bit, 4= very much). Total FKSI score 0 to 60; higher scores=better health states (Individual questions may be reversed coded, as appropriate). (NCT00920816)
Timeframe: Baseline (Pre-dose on Cycle [C]1 Day [D]1), D1 of each cycle until C21, end of treatment (up to Week 103), follow-up (28 days after last dose)

Duration of Tumor Response

Using RECIST criteria: date of 1st objective tumor response (CR or PR) subsequently confirmed to date of 1st objective tumor progression or to death due to any cause within 28 days after last dose of study medication, whichever was first. Censored on day after the date of the last oncologic assessment documenting no tumor progression. (NCT00137423)
Timeframe: 4 week treatment cycles up to 1 year in absence of withdrawal criteria requiring discontinuation includes 28 day post study follow up

Objective Response (Complete Response[CR] + Partial Response[PR]) in Subjects

Confirmed objective responses using RECIST criteria defined as responses persisting on repeat imaging study for 2 assessments with at least 4 weeks between, and evaluating all target and non-target sites followed since baseline. Two PRs separated by an SD or NE visit in between was considered a confirmed response if the 2 PRs were > 4 weeks apart. CR=disappearance of all target lesions. PR is a >=30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions. (NCT00137423)
Timeframe: 4 week treatment cycles up to 1 year in absence of withdrawal criteria requiring discontinuation includes 28 day post study follow up

Overall Survival

Overall survival is time from the date of first dose of medication to the date of death due to any cause (NCT00137423)
Timeframe: 4 week treatment cycles up to 1 year in absence of withdrawal criteria requiring discontinuation includes 28 day post study follow up

Progression Free Survival (PFS)

Using RECIST criteria: Time from date 1st dose study medication to date 1st documentation of objective tumor progression or death due to any cause occurring on treatment including within 28 days after last dose, whichever occurred 1st. Censored on day following the date of last oncologic assessment documenting absence of tumor progression. PFS based on the number of subjects with measurable disease at baseline, the correct histological cancer type, and had disease that was refractory to prior cytokine-based therapy(105 in total group). (NCT00137423)
Timeframe: 4 week treatment cycles up to 1 year in absence of withdrawal criteria requiring discontinuation includes 28 day post study follow up

Time to Tumor Progression (TTP)

Time from date of first dose of study medication to date of first documentation of objective tumor progression using RECIST criteria that occurred on treatment including within 28 days after the last dose of study medication. TTP censored on the day following the date of last oncologic assessment documenting absence of tumor progression. TTP based on the number of subjects with measurable disease at baseline, the correct histological cancer type, and had disease that was refractory to prior cytokine-based therapy(105 in total group). (NCT00137423)
Timeframe: 4 week treatment cycles up to 1 year in absence of withdrawal criteria requiring discontinuation includes 28 day post study follow up

Change From Baseline in Euro-QoL Five Dimension (EQ-5D) Weighted Health Index

EQ-5D health status in 5 dimensions (mobility, self-care, pain / discomfort, anxiety / depression, usual activities) with a weighted health index based on general population values where 0.0=death and 1.0 = perfect health. Change: median index score at observation minus median index score at baseline. (NCT00137423)
Timeframe: Day 1 and day 15 of each treatment cycle from cycle 1 to cycle 4; day 1 of each treatment cycle after cycle 4 up to one year.

Change From Baseline in EuroQoL Visual Analog Scale (EQ-VAS) Overall Health Thermometer Score

"EQ-VAS score on the self-rated thermometer indicated the patient's own assessment of their health status from 0 (worst) to 100 (best) imaginable health state. Change: median score at observation minus median score at baseline. Maximum changes (increase or decrease from baseline)." (NCT00137423)
Timeframe: Day 1 and day 15 of each treatment cycle from cycle 1 to cycle 4; day 1 of each treatment cycle after cycle 4 up to one year.

Summary of FACIT Fatigue Scale Overall Score

FACIT Fatigue Scale: Overall score from 13-questionnaire, which measures fatigue / asthenia for patients with chronic, life-threatening illnesses. For each question, a patient rates his / her condition for the past week on a 5-point Likert scale ranging from 0 (not at all) to 4 (very much). Higher scores always represent less fatigue / asthenia. Outcome based on completed questionnaires. (NCT00137423)
Timeframe: Day 1 and day 15 of each treatment cycle from cycle 1 to cycle 4; day 1 of each treatment cycle after cycle 4 up to one year.

Overall Survival (OS)

OS was defined as the time from randomization to death due to any cause, censored at the last date known alive. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death). (NCT00631371)
Timeframe: Baseline until death due to any cause, assessed every 8 weeks (up to cut-off date: 19 April 2012)

Percentage of Participants With Objective Response (Complete Response/Partial Response): Independent-Assessment

Percentage of participants with OR based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST. Confirmed response were those that persisted on repeat imaging study at least 4 weeks after initial documentation of response. CR was defined as disappearance of all lesions (target and/or non target). PR were those with at least 30% decrease in sum of the longest dimensions of target lesions taking as a reference the baseline sum longest dimensions, with non target lesions not increased or absent. (NCT00631371)
Timeframe: Baseline until disease progression, initiation of new anticancer treatment, or death, assessed every 8 weeks (up to cut-off date: 19 April 2012)

Progression-Free Survival (PFS): Independent-Assessment

PFS was defined as the interval from the date of randomization until the earlier date of progression or death. Progression was assessed by independent imaging reviewers using Response Evaluation Criteria in Solid Tumors (RECIST) criteria which is 20% increase in sum of longest diameter of target lesions from nadir (the lowest blood counts); measurable increase in non-target lesion; appearance of new lesions. (NCT00631371)
Timeframe: Baseline until disease progression, initiation of new anticancer treatment, or death, assessed every 8 weeks (up to cut-off date: 19 April 2012)

Progression-Free Survival (PFS): Investigator-Assessment

PFS was defined as the interval from the date of randomization until the earlier date of progression or death. Progression was assessed by investigator imaging reviewers using RECIST criteria which is 20% increase in sum of longest diameter of target lesions from nadir (the lowest blood counts); measurable increase in non-target lesion; appearance of new lesions. (NCT00631371)
Timeframe: Baseline until disease progression, initiation of new anticancer treatment, or death, assessed every 8 weeks (up to cut-off date: 19 April 2012)

Duration of Response (DR)

DR: time from first documentation of objective tumor response (CR or PR), that was subsequently confirmed, to the first documentation of PD or to death due to any cause, whichever occurred first as per RECIST version 1.0, a) CR: disappearance of all target, non target lesions and no appearance of new lesions, documented on 2 occasions separated by at least 4 weeks, b) PR: at least 30 % decrease in sum of LD of target lesions taking as reference baseline sum of LD, without progression of non target lesions, no appearance of new lesions, c) PD: >=20% increase in sum of LD of the target lesions taking as a reference smallest sum of LD recorded since the start of treatment or unequivocal progression in non-target lesions or appearance of 1 or more new lesions. Occurrence of pleural effusion or ascites if demonstrated by cytological investigation, not previously documented. New bone lesions not previously documented if confirmed by computed tomography/magnetic resonance imaging or X-ray. (NCT00678392)
Timeframe: From initiation of treatment up to follow-up period (up to 3 years)

Objective Response Rate (ORR)

ORR = percentage of participants with confirmed complete response (CR) or confirmed partial response (PR) according to RECIST version 1.0 recorded from first dose of study treatment until PD or death due to any cause. CR: disappearance of all target, non target lesions and no appearance of new lesions, documented on 2 occasions separated by at least 4 weeks. PR: at least 30 % decrease in sum of LD of target lesions taking as reference baseline sum of LD, without progression of non target lesions, no appearance of new lesions. PD: >=20% increase in sum of LD of the target lesions taking as a reference smallest sum of LD recorded since the start of treatment or unequivocal progression in non-target lesions or appearance of 1 or more new lesions. Occurrence of pleural effusion or ascites if demonstrated by cytological investigation, not previously documented. New bone lesions not previously documented if confirmed by computed tomography/magnetic resonance imaging or X-ray. (NCT00678392)
Timeframe: From initiation of treatment up to follow-up period (up to 3 years)

Overall Survival (OS)

OS was defined as the duration from start of study treatment to date of death due to any cause. OS was calculated as (months) = (date of death minus the date of first dose of study medication plus 1) divided by 30.4. For participants who were alive, overall survival was censored on last date the participants were known to be alive. (NCT00678392)
Timeframe: From initiation of treatment up to follow-up period (up to 3 years)

Progression-Free Survival (PFS)

PFS was defined as the time in months from start of study treatment to the first documentation of objective tumor progression of disease (PD) or to death due to any cause, whichever occurs first. PD was assessed by response evaluation criteria in solid tumors (RECIST) version 1.0. PD: >=20 percent (%) increase in the sum of the longest dimensions (LD) of the target lesions taking as a reference the smallest sum of the LD recorded since the start of treatment or unequivocal progression in non-target lesions or the appearance of 1 or more new lesions. Occurrence of a pleural effusion or ascites was also considered PD if demonstrated by cytological investigation and it was not previously documented. New bone lesions not previously documented were considered PD if confirmed by computed tomography/magnetic resonance imaging or X-ray. (NCT00678392)
Timeframe: From initiation of treatment up to follow-up period (up to 3 years)

Euro Quality of Life Questionnaire- 5 Dimension (EQ-5D): Health State Profile Utility Score

EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility or index score. Health state profile component assesses level of health for 5 domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each domain was rated on a 3-point response scale (1= no problems, 2= some/moderate problems and 3= extreme problems). Scoring formula developed by EuroQol Group assigned a utility value for each domain in the profile. Score were transformed and resulted in a total score range of 0 to 1, with higher scores indicating better health. (NCT00678392)
Timeframe: Baseline (Predose on Cycle 1 Day 1) , Day 1 of each cycle until Cycle 21, End of treatment (Day 670) and Follow-up visit (Day 698)

Euro Quality of Life Questionnaire- 5 Dimension (EQ-5D): Visual Analog Scale (VAS)

EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. VAS component: participants rated their current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate a better health. (NCT00678392)
Timeframe: Baseline (Predose on Cycle 1 Day 1) , Day 1 of each cycle until Cycle 21, End of treatment (Day 670) and Follow-up visit (Day 698)

Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15) Score

FKSI was used to assess quality of life (QoL) for those diagnosed with renal cell cancer and consisted of 15 items (lack of energy, side effects, pain, losing weight, bone pain, fatigue, enjoying life, short of breath, worsened condition, appetite, coughing, bothered by fevers, ability to work, hematuria and sleep). Each of the 15 items was answered on a 5-point Likert-type scale ranging from 0 to 4 (0= not at all, 1= a little bit, 2= somewhat, 3= quite a bit, 4= very much). Total FKSI score = sum of the 15 item scores; total range: 0 - 60; 0 (no symptoms) to 60 (very much); higher scores indicate greater presence of symptoms. (NCT00678392)
Timeframe: Baseline (Predose on Cycle 1 Day 1) , Day 1 of each cycle until Cycle 21, End of treatment (Day 670) and Follow-up visit (Day 698)

Functional Assessment of Cancer Therapy Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) Score

FKSI-DRS was used to assess quality of life for those diagnosed with renal cell cancer and consisted of 9 items (lack of energy, pain, losing weight, bone pain, fatigue, short of breath, coughing, bothered by fevers, and hematuria). Each of the 9 items was answered on a 5-point Likert-type scale ranging from 0 to 4 (0= not at all, 1= a little bit, 2= somewhat, 3= quite a bit, 4= very much). Total FKSI-DRS score = sum of the 9 item scores; total range: 0 - 36; 0 (no symptoms) to 36 (very much); higher scores indicate greater presence of symptoms. (NCT00678392)
Timeframe: Baseline (Predose on Cycle 1 Day 1) , Day 1 of each cycle until Cycle 21, End of treatment (Day 670) and Follow-up visit (Day 698)

Number of Participants With Clinically Significant Laboratory Abnormalities: Biochemistry

Biochemistry laboratory test included parameters: alanine aminotransferase, alkaline phosphatase, amylase, aspartate aminotransferase, bicarbonate, bilirubin, creatinine, hypercalcemia, hyperglycemia, hyperkalemia, hypernatremia, hypoalbuminemia, hypocalcemia, hypoglycemia, hypokalemia, hyponatremia, hypophosphatemia and lipase. Abnormalities were assessed by CTCAE Grade Version 2 for severity: Grade 1= mild; Grade 2= moderate; Grade 3= severe and Grade 4= life-threatening or disabling. (NCT00678392)
Timeframe: From initiation of treatment up to follow-up period (up to 3 years)

Number of Participants With Clinically Significant Laboratory Abnormalities: Hematology

Hematology laboratory test included hemoglobin, platelet count, white blood cells count, neutrophils and lymphocytes. Abnormalities were assessed by CTCAE Grade Version 2 for severity: Grade 1= mild; Grade 2= moderate; Grade 3= severe and Grade 4= life-threatening or disabling. (NCT00678392)
Timeframe: From initiation of treatment up to follow-up period (up to 3 years)

Number of Participants With Clinically Significant Laboratory Abnormalities: Urinalysis

Urinalysis included urine blood/ hemoglobin, glucose and protein. Abnormalities were assessed by CTCAE Grade Version 2 for severity: Grade 1= mild; Grade 2= moderate; Grade 3= severe and Grade 4= life-threatening or disabling. (NCT00678392)
Timeframe: From initiation of treatment up to follow-up period (up to 3 years)

Percentage of Participants With Adverse Events (AEs) by Severity

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Severity of the AEs was graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. Grade 1= mild; Grade 2= moderate; Grade 3= severe; Grade 4= life-threatening or disabling; Grade 5= death related to AE. (NCT00678392)
Timeframe: From initiation of treatment up to follow-up period (up to 3 years)

Percentage of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life- threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. AEs included both serious and non-serious AEs. (NCT00678392)
Timeframe: From initiation of treatment up to follow-up period (up to 3 years)

Percentage of Participants With Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs)

An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life -threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both serious and non -serious AEs. (NCT00678392)
Timeframe: From initiation of treatment up to follow-up period (up to 3 years)

1-Year Survival

One year survival rate defined as the probability that a subject was alive 1 year after the date of first study treatment. (NCT00338884)
Timeframe: From start of treatment through Day 1 of Weeks 5, 9, and every 8 weeks thereafter up until 1 year

Duration of Response (DR)

Time from start of the first documentation of objective tumor response (CR or PR) to the first documentation of objective tumor progression or to death due to to any cause, whichever occurred first. If tumor progression data included more than 1 date, the first date was used. DR was calculated as [the end date for DR minus first CR or PR that was subsequently confirmed +1]/7. (NCT00338884)
Timeframe: From start of treatment through Day 1 of Weeks 5, 9, and every 8 weeks thereafter or death due to any cause

Number of Subjects With Overall Confirmed Objective Response (OR)

OR = subjects with confirmed complete response (CR) or partial response (PR) according to the Response Evaluation Criteria in Solid Tumors (RECIST) persisting > = 4 weeks after initial documentation of response. A CR was defined as the disappearance of all target lesions. A PR was defined as a ≥ 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions. (NCT00338884)
Timeframe: From start of treatment through Day 1 of Weeks 5, 9, and every 8 weeks thereafter

Progression-Free Survival (PFS)

Time from start of study medication to first documentation of objective tumor progression or to death due to any cause, whichever occurred first. If tumor progression data included more than 1 date, the first date was used. PFS (in months) was calculated as (first event date minus first dose date +1)/7. (NCT00338884)
Timeframe: From start of treatment through Day 1 of Weeks 5, 9, and every 8 weeks thereafter or death

Soluble VEGF Receptor 2 (sVEGFR2) Concentration at Baseline

(NCT00338884)
Timeframe: Baseline

Time to Tumor Progression (TTP)

Time from date of first dose of study medication to first documentation of objective tumor progression. The 50% quartile point estimate is provided. The criteria for tumor progression was according to RECIST. (NCT00338884)
Timeframe: From start of treatment through Day 1 of Weeks 5, 9, and every 8 weeks thereafter

Vascular Endothelial Growth Factor (VEGF) Concentration at Baseline

(NCT00338884)
Timeframe: Baseline

Cancer Related Symptoms, Well-Being, and Concerns

FACT-Advanced Kidney Cancer Symptom Index (FKSI) Questionnaire: subscale designed to be a stand-alone instrument to measure symptoms and quality of life in patients with advanced kidney cancer. Contains 15 questions. Each question was answered on a 5-point Likert-type scale ranging from 0 to 4 (0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much). Total FKSI score = sum score of the 15 item scores; total range: 0 - 60; 0 (most severe symptoms and concerns) to 60 (no symptoms or concerns). End of treatment assessment was for subjects who completed the study only. (NCT00338884)
Timeframe: Baseline (Day 1, Week 1), Day 1 of Weeks 3, 5, 7, 9, 11, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, Week 53 (End of Treatment)

Ctrough of SU-012662 (Sunitinib's Metabolite)

Ctrough = the concentration prior to study drug administration. (NCT00338884)
Timeframe: Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53

Ctrough of Total Drug (Sunitinib + SU-012662)

Ctrough = the concentration prior to study drug administration. (NCT00338884)
Timeframe: Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53

Ctrough Stratified by CR or PR Versus PD for SU-012662 (Sunitinib's Metabolite)

Summary statistics of ctrough at each time point by group (CR or PR versus PD) are presented. (NCT00338884)
Timeframe: Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53

Ctrough Stratified by CR or PR Versus PD for Total Drug (Sunitinib + SU012662)

Summary statistics of ctrough at each time point by group (CR or PR versus PD) are presented. (NCT00338884)
Timeframe: Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53

Ctrough Stratified by CR or PR Versus Progressive Disease (PD) for Sunitinib

Summary statistics of ctrough at each time point by group (CR or PR versus PD) are presented. (NCT00338884)
Timeframe: Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53

Ctrough Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) for SU-012662 (Sunitinib's Metabolite)

Summary statistics of ctrough at each time point by group (CR or PR or SD versus PD) are presented. (NCT00338884)
Timeframe: Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53

Ctrough Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) for Total Drug (Sunitinib + SU012662)

Summary statistics of ctrough at each time point by group (CR or PR or SD versus PD) are presented. (NCT00338884)
Timeframe: Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53

Ctrough Stratified by Tumor Response (CR or PR or [Stable Disease (SD) > = 12 Weeks] Versus PD) for Sunitinib

Summary statistics of ctrough at each time point by group (CR or PR or SD versus PD) are presented. (NCT00338884)
Timeframe: Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53

Patient-Assessed Fatigue

Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) Scale: Overall score from 13-question questionnaire (measures fatigue/asthenia for patients with chronic, life-threatening illnesses). For each question, patient rates condition for the past week on a 5-point Likert scale ranging from 0 (not at all) to 4 (very much). Total FACIT-Fatigue score = sum score of the 13 question scores; total range: 0 - 52; higher total score represents less fatigue. End of treatment assessment was for subjects who completed the study only. (NCT00338884)
Timeframe: Baseline (Day 1, Week 1), Day 1 of Weeks 3, 5, 7, 9, 11, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, Week 53 (End of Treatment)

sVEGFR2 at Baseline Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD)

Summary statistics of sVEGFR2 at baseline by group (CR or PR or SD versus PD) are presented. (NCT00338884)
Timeframe: Baseline (Cycle 1, Day 1)

sVEGFR2 at Baseline Stratified by Tumor Response (CR or PR Versus PD)

Summary statistics of sVEGFR2 at baseline by group (CR or PR versus PD) are presented. (NCT00338884)
Timeframe: Baseline (Cycle 1, Day 1)

sVEGFR2 Ratio to Baseline at Each Time Point

sVEGFR2 concentration at each time point divided by sVEGFR2 concentration at baseline (ratio to baseline). (NCT00338884)
Timeframe: Baseline to Day 1 of Weeks 3 through 53

sVEGFR2 Ratio to Baseline Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD)

Median sVEGFR2 concentration at each time point divided by sVEGFR2 concentration at baseline (ratio to baseline) for subjects with tumor response (CR or PR or [SD > = 12 weeks] versus PD). (NCT00338884)
Timeframe: Baseline to Day 1 of Weeks 3 through 53

sVEGFR2 Ratio to Baseline Stratified by Tumor Response (CR or PR Versus PD)

Median sVEGFR2 concentration at each time point divided by sVEGFR2 concentration at baseline (ratio to baseline) for subjects with tumor response (CR or PR versus PD). (NCT00338884)
Timeframe: Baseline to Day 1 of Weeks 3 through 53

Trough Plasma Concentrations (Ctrough) of Sunitinib

Ctrough = the concentration prior to study drug administration. (NCT00338884)
Timeframe: Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53

VEGF at Baseline Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD)

Summary statistics of VEGF at baseline by group (CR or PR or SD versus PD) are presented. (NCT00338884)
Timeframe: Baseline (Cycle 1, Day 1)

VEGF at Baseline Stratified by Tumor Response (CR or PR Versus PD)

Summary statistics of VEGF at baseline by group (CR or PR versus PD) are presented. (NCT00338884)
Timeframe: Baseline (Cycle 1, Day 1)

VEGF Ratio to Baseline at Each Time Point

VEGF concentration at each time point divided by VEGF concentration at baseline (ratio to baseline). (NCT00338884)
Timeframe: Baseline to Day 1 of Weeks 3 through 53

VEGF Ratio to Baseline Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD)

Median VEGF concentration at each time point divided by VEGF concentration at baseline (ratio to baseline) for subjects with tumor response (CR or PR or [SD > = 12 weeks] versus PD). (NCT00338884)
Timeframe: Baseline to Day 1 of Weeks 3 through 53

VEGF Ratio to Baseline Stratified by Tumor Response (CR or PR Versus PD)

Median VEGF concentration at each time point divided by VEGF concentration at baseline (ratio to baseline) for subjects with tumor response (CR or PR versus PD). (NCT00338884)
Timeframe: Baseline to Day 1 of Weeks 3 through 53

Duration of Response (DR)

Duration of response as defined by the time from CR or PR (whichever status recorded first) until the date of death or PD was objectively documented. Median and its 95 percent confidence interval (95% CI) were estimated using Kaplan-Meier method. (NCT00474786)
Timeframe: Baseline up to 24 Months

Overall Survival (OS)

Overall survival was the duration from randomization to death. For participants who are alive, overall survival was censored at the last contact. (NCT00474786)
Timeframe: Baseline to date of death from any cause (up to 24 months)

Percentage of Participants With Tumor Response

Percentage of participants with tumor response based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST and evaluated by independent central review. CR/PR persisted on repeat imaging study at least 4 weeks after initial documentation of response. PR had at least 30 percent decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD. (NCT00474786)
Timeframe: Baseline up to 24 Months

Progression Free Survival (PFS) by Investigator Assessment

Interval from date of randomization until documentation of PD by an investigator tumor assessment, symptomatic deterioration, or death for any reason whichever occurred first. (NCT00474786)
Timeframe: Baseline up to 24 Months

Progression-Free Survival (PFS)

Interval from date of randomization until documentation of progressive disease (PD) by an independent tumor assessment according to Response Evaluation Criteria in Solid Tumor (RECIST) or death for any reason whichever occurred first. (NCT00474786)
Timeframe: Baseline up to 24 Months

Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

Counts of participants who had treatment-emergent adverse events (TEAEs), defined as newly occurring or worsening after first dose. Relatedness to [study drug] was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category. (NCT00474786)
Timeframe: Baseline up to 24 months

Percentage of Participants With PFS Events at 12, 24 and 36 Weeks by Independent Assessment

PFS: Interval from date of randomization until documentation of PD by an independent tumor assessment according to RECIST or death for any reason whichever occurred first. PFS calculated as (Weeks)=(randomization date minus first dose date plus 1) divided by 7. (NCT00474786)
Timeframe: Weeks 12, 24, and 36

Duration of Response (DR)

Time from the first documentation of objective tumor response to objective tumor progression or death due to any cause. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 30.44. DR was calculated for the subgroup of participants with a confirmed objective tumor response. (NCT00267748)
Timeframe: From date of randomization until the date of first documented progression or date of death due to any cause, assessed up to a maximum of 2 years

FACT-Kidney Symptom Index for Disease Related Symptoms (FKSI-DRS)

"FKSI-DRS is a subset of FKSI which is a questionnaire for Functional Assessment of Cancer Therapy -Kidney Symptom Index used to assess QoL/participant-reported outcomes for participants diagnosed with renal cell cancer.~The FKSI contained 15 questions and the FKSI-DRS consisted of 9 questions each ranging from 0 (not at all) to 4 (very much) so that FKSI-DRS ranged between 0-36. Since the questions could be reversed coded, as appropriate, before calculating FKSI-DRS, 0 and 36 could be considered the worst and best health states based on the 9 questions comprising FKSI-DRS." (NCT00267748)
Timeframe: From date of randomization until the date of first documented progression or date of death due to any cause, assessed up to a maximum of 2 years

Functional Assessment of Cancer Therapy-General (FACT-G)

FACT-G is core questionnaire of Functional Assessment of Chronic Illness Therapy (FACIT) measurement system to evaluate quality of life (QoL) in cancer population.FACT-G consisted of 27 questions grouped in 4 domains of general Health-Related QoL(HRQoL):Physical Well-being(PWB),Social/Family Well-Being (SWB),Emotional Well-Being (EWB) and Functional Well-Being (FWB);each ranging from 0 (not at all) to 4 (very much) so that FACT-G ranged between 0-108.Since questions could be reversed coded, as appropriate, before calculating FACT-G,0 and 108 could be considered worst and best health states. (NCT00267748)
Timeframe: From date of randomization until the date of first documented progression or date of death due to any cause, assessed up to a maximum of 2 years

Percentage of Participants With Objective Response (OR)

Percentage of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed responses are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. CR are defined as the disappearance of all lesions (target and/or non target). PR are those with atleast 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions. (NCT00267748)
Timeframe: From date of randomization until the date of first documented progression or date of death due to any cause, assessed up to a maximum of 2 years

Overall Survival (OS) Assessed Using MSKCC Prognostic Factors Model

MSKCC Prognostic Factor Model assessed as low (0), intermediate (1-2) or high (=>3) based upon number of criteria present. Criteria as follows: Karnofsky performance status < 80 %, Lactate dehydrogenase > 1.5 * Upper limit of Normal, Hemoglobin < lower limit of normal for local lab, Corrected serum calcium > 10 mg/dL; Time from first diagnosis of renal cell carcinoma to start of systemic therapy of < 1 year. OS was defined as time from date of start of treatment to date of death due to any cause. OS, in months, was calculated as (event date -start of treatment date + 1)/30.44. (NCT00267748)
Timeframe: From date of randomization until the date of first documented progression or date of death due to any cause, assessed up to a maximum of 2 years

Time to Tumor Progression (TTP) Assessed Using Memorial Sloan-Kettering Cancer Center (MSKCC) Prognostic Factors Model

MSKCC Prognostic Factor Model assessed as low(0),intermediate(1-2) or high(=>3) based on number of criteria present such as Karnofsky performance status < 80 %, Lactate dehydrogenase > 1.5 * Upper limit of Normal,Hemoglobin < lower limit of normal, serum calcium > 10 mg/dL;Time from first diagnosis of renal cell carcinoma to start of systemic therapy of < 1 year.TTP was time from start of study treatment to first documentation of objective tumor progression or death due to cancer.TTP was calculated as (first event date minus date of first dose of study medication plus 1) divided by 30.44. (NCT00267748)
Timeframe: From date of randomization until the date of first documented progression or date of death due to any cause, assessed up to a maximum of 2 years

Duration of Response (DR)

"Time in weeks from the first documentation of objective tumor response to objective tumor progression or death due to any cancer. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 7.~DR was calculated for the subgroup of patients with a confirmed objective tumor response." (NCT00077974)
Timeframe: Day 28 of Cycles 1-5, Day 28 of even Cycles thereafter or death due to cancer

Number of Subjects With Confirmed Objective Response According to Response Evaluation Criteria in Solid Tumors(RECIST)

Overall confirmed objective response = confirmed Complete Response (CR) or confirmed Partial Response (PR) according to RECIST. CR defined as disappearance of all target lesions. PR defined as >= 30 percent decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions. (NCT00077974)
Timeframe: From start of study treatment until Day 28 of Cycles 1-5, Day 28 of even Cycles thereafter

Overall Survival (OS)

Time in weeks from the start of study treatment to date of death due to any cause. OS was calculated as (the death date minus the date of first dose of study medication plus 1) divided by 7. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the subject current status was death). (NCT00077974)
Timeframe: From start of study treatment until death

Progression-free Survival (PFS)

"Time in weeks from start of study treatment to first documentation of objective tumor progression or death due to any cause. PFS was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 7. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from adverse event (AE) data (where the outcome was Death)." (NCT00077974)
Timeframe: From start of study treatment until Day 28 of Cycles 1-5, Day 28 of even Cycles thereafter or death

Time to Tumor Progression (TTP)

Time in weeks from start of study treatment to first documentation of objective tumor progression or death due to cancer, whichever comes first. TTP was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 7. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]). (NCT00077974)
Timeframe: From start of study treatment until Day 28 of Cycles 1-5, Day 28 of even Cycles thereafter

Dose Corrected Plasma Trough Concentrations of Sunitinib

Dose corrected plasma trough (predose) (Cmin) concentrations of sunitinib. Dose-corrected trough concentrations were set to missing for trough samples collected outside acceptable times from dose administration, samples not collected within scheduled day range, samples with missing collection or administration dates or times, samples collected with dose interruption, and samples collected with inconsistent dose level within 10 days of last dose date. (NCT00077974)
Timeframe: Day 28 of Cycle 1 through 4, Day 1 of Cycles 5 and greater

Dose Corrected Plasma Trough Concentrations of Sunitinib Metabolite

Dose corrected plasma trough (predose) (Cmin) concentrations of sunitinib metabolite (SU012662). Dose-corrected trough concentrations were set to missing for trough samples collected outside acceptable times from dose administration, samples not collected within scheduled day range, samples with missing collection or administration dates or times, samples collected with dose interruption, and samples collected with inconsistent dose level within 10 days of last dose date. (NCT00077974)
Timeframe: Day 28 of Cycle 1 through 4, Day 1 of Cycles 5 and greater

Dose Corrected Plasma Trough Concentrations of Sunitinib Plus Metabolite

Dose corrected plasma trough (predose) (Cmin) concentrations of sunitinib plus its metabolite (SU012662). Dose-corrected trough concentrations were set to missing for trough samples collected outside acceptable times from dose administration, samples not collected within scheduled day range, samples with missing collection or administration dates or times, samples collected with dose interruption, and samples collected with inconsistent dose level within 10 days of last dose date. (NCT00077974)
Timeframe: Day 28 of Cycle 1 through 4, Day 1 of Cycles 5 and greater

Observed Plasma Trough Concentrations of Sunitinib

Observed plasma trough (predose) (Cmin) concentrations of sunitinib (NCT00077974)
Timeframe: Day 28 of Cycle 1 through 4, Day 1 of Cycles 5 and greater

Observed Plasma Trough Concentrations of Sunitinib Metabolite

Observed plasma trough (predose) (Cmin) concentrations of sunitinib metabolite (SU012662) (NCT00077974)
Timeframe: Day 28 of Cycle 1 through 4, Day 1 of Cycles 5 and greater

Observed Plasma Trough Concentrations of Sunitinib Plus Metabolite

Observed plasma trough (predose) concentrations of sunitinib plus its metabolite (SU012662) (NCT00077974)
Timeframe: Day 28 of Cycle 1 through 4, Day 1 of Cycles 5 and greater

Percent Chance of Patient Survival

Probability of survival 1 year and 2 years after the first dose of study treatment (NCT00077974)
Timeframe: From start of study treatment until death

Duration of Response (DR), Core Radiology Assessement

Duration of response (DR) = time from the first documentation of objective tumor response to the first documentation of objective tumor progression or to death due to any cause. DR data were censored on the day following the date of the last on treatment (including 28 day follow-up period) tumor assessment documenting absence of progressive disease for subjects without objective tumor progression who did not die due to any cause while on treatment or who were given anti-tumor treatment other than study treatment prior to observing tumor progression. (NCT00083889)
Timeframe: Day 28 of each cycle: duraton of treatment phase

Duration of Response (DR), Investigator's Assessment

Duration of response (DR) = time from the first documentation of objective tumor response to the first documentaion of objective tumor progression or to death due to any cause. DR data were censored on the day following the date of the last on treatment (including 28 day follow-up period) tumor assessment documenting absence of progressive disease for subjects without objective tumor progression who did not die due to any cause while on treatment or who were given anti-tumor treatment other than study treatment prior to observing tumor progression. (NCT00083889)
Timeframe: Day 28 of each cycle: duration of treatment phase

Incremental Cost Effectiveness Ratio (ICER)

Incremental cost effectiveness ratio (ICER) of sunitinib compared to IFN-a as first-line treatment for MRCC, defined as the ratio of the incremental cost of treatment over the incremental effectiveness; effectiveness measured as quality adjusted life year (QALY) gain. This objective was not addressed in the clinical study report, but an interim analysis of cost-effectiveness was presented separately. These results were not available for inclusion at the time of this posting. (NCT00083889)
Timeframe: post study measurement

Objective Response, Core Radiology Assessment

Objective response (OR) = the number of patients with confirmed complete response (CR) and confirmed partial response (PR) according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria, relative to all randomized patients. CR was defined as the disappearance of all target lesions. PR was defined as a ≥ 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions. Confirmed responses (CR or PR) = those that persisted on repeat imaging study >= 4 weeks after initial documentation of response. (NCT00083889)
Timeframe: Day 28 of each 6-week cycle: duration of treatment phase

Objective Response, Investigator's Assessment

Objective response (OR) = the number of patients with confirmed complete response (CR) and confirmed partial response (PR) according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria, relative to all randomized patients. CR was defined as the disappearance of all target lesions. PR was defined as a ≥ 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions. Confirmed responses = those that persist on repeat imaging study >= 4 weeks after initial documentation of response. (NCT00083889)
Timeframe: Day 28 of each 6-week cycle: duration of treatment phase

Overall Survival (OS)

Overall survival (OS) = time from date of randomization to date of death due to any cause. For patients not expiring, survival time was censored at the last date they were known to be alive. Patients lacking data beyond randomization had their survival times censored at the date of randomization with a duration of 1 day. (NCT00083889)
Timeframe: Clinic visit or telephone contact every 2 months until death

Progression-Free Survival (PFS), Core Radiology Assessment

Progression-free survival (PFS) = time from randomization to first documentation of objective tumor progression or to death due to any cause, whichever occured first. If tumor progression data included more than 1 date, the first date was used. PFS = first event date minus the date of randomization + 1. On study included treatment plus 28-day follow-up periods. (NCT00083889)
Timeframe: Day 28 of each 6-week cycle: duration of treatment phase

Progression-Free Survival (PFS), Investigator's Assessment

Progression-free survival = time from randomization to first documentation of objective tumor progression or to death due to any cause, whichever occured first. PFS = first event date minus the date of randomization + 1). On study included treatment plus 28-day follow-up periods. (NCT00083889)
Timeframe: Day 28 of each 6-week cycle: duration of treatment phase

Time to Tumor Progression (TTP), Core Radiology Assessment

TTP = time from randomization to first documentation of objective tumor progression. TTP data were censored on the day following the date of last on treatment (including 28 day follow-up period) tumor assessment documenting absence of progressive disease for subjects who did not have objective tumor progression while on treatment or who were given anti-tumor treatment other than study treatment prior to documentation of objective tumor progression. Subjects with no tumor assessments after randomization had TTP censored on the date of randomization with a duration of 1 day. (NCT00083889)
Timeframe: Randomization to first documentation of tumor progression: duration of treatment phase

Time to Tumor Progression (TTP), Investigator's Assessment

TTP = time from randomization to first documentation of objective tumor progression. TTP data were censored on the day following the date of last on treatment (including 28 day follow-up period) tumor assessment documenting absence of progressive disease for subjects who did not have objective tumor progression while on treatment or who were given anti-tumor treatment other than the study treatment prior to documentation of objective tumor progression. Subjects with no tumor assessments after randomization had TTP censored on the date of randomization with a duration of 1 day. (NCT00083889)
Timeframe: Randomization to first documentation of tumor progression: duration of treatment phase

Ctrough Concentrations of Metabolite SU012662

Subject observed Ctrough (trough drug) concentrations of active metabolite SU012662 per cycle and study day determined by plasma trough samples collected from a subset of patients. Steady-state observed trough concentrations were dose corrected to the starting dose (reference dose) where appropriate. Concentrations below the limits of quantitation (BLQ) were set to 0. Ctrough = minimum (trough) plasma concentration (nanograms per milliliter [ng/mL]). (NCT00083889)
Timeframe: Day 28 of Cycle 1 to Cycle 4

Ctrough Concentrations of SU011248

Subject observed Ctrough (trough drug) concentrations of SU011248 per cycle and study day determined by plasma trough samples collected from a subset of patients. Steady-state observed trough concentrations were dose corrected to the starting dose (reference dose) where appropriate. Concentrations below the limits of quantitation (BLQ) were set to 0. Ctrough = minimum (trough) plasma concentration (nanograms per milliliter [ng/mL]). (NCT00083889)
Timeframe: Day 28 of Cycle 1 to Cycle 4

Ctrough Concentrations of SU011248 and Active Metabolite SU012662

Subject observed Ctrough (trough drug) concentrations of total drug (SU011248 and its active metabolite SU012662) per cycle and study day determined by plasma trough samples collected from a subset of patients. Steady-state observed trough concentrations were dose corrected to the starting dose (reference dose) where appropriate. Concentrations below the limits of quantitation (BLQ) were set to 0. Ctrough = minimum (trough) plasma concentration (nanograms per milliliter [ng/mL]). (NCT00083889)
Timeframe: Day 28 of Cycle 1 to Cycle 4

Euro-QoL Visual Analog Scale (EQ-VAS)

EQ-VAS: overall self-rating rating of the patient's current health state using a 20 cm Visual Analog Scale (EQ-VAS), also called the health state thermometer) is a metric measurement (in 2 mm interval) from the visual analog scale which ranges between 0 (worse imaginable health state) and 100 (best imaginable health state). (NCT00083889)
Timeframe: Day 1 & 28 of each cycle: duration of treatment phase

EuroQoL Five Dimension (EQ-5D) Health State Index

EQ-5D Health State Index: a brief, self-administered generic health status instrument. Respondents were asked to describe their current health state on each of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety or depression) on a three-level scale (1=no problem, 2=some problem, and 3=extreme problem). A maximum score of 1 can be derived from these 5 dimensions by score conversion; range: -0.39 (worst health state)to 1.00 (best health state). This descriptive system classifies respondents into one of 243 possible distinct health states (EQ-5D descriptive system). (NCT00083889)
Timeframe: Day 1 & 28 of each cycle: duration of treatment phase

FACT-Kidney Symptom Index (FKSI) Subscale

FACT-Kidney Symptom Index (FKSI) subscale designed to be a stand-alone instrument to measure symptoms and quality of life in patients with advanced kidney cancer. Contains 15 questions; some questions overlap with the FACT-G questions. Each question was answered on a five-point Likert-type scale ranging from 0 to 4 (0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much). Total FKSI score = sum score of the 15 item scores; total range: 0 - 60; 0 (most severe symptoms and concerns) to 60 (no symptoms or concerns). (NCT00083889)
Timeframe: Day 1 & 28 of each cycle: duration of treatment phase

FACT-Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) Subscale

FACT-Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) subscale of the FKSI to measure advanced kidney cancer disease related symptoms. Includes 9 items: lack of energy, pain, losing weight, bone pain, fatigue, short of breath, coughing, bothered by fevers, and hematuria. Each question was answered on a five-point Likert-type scale ranging from 0 (not at all) to 4 (very much). Score = the sum score of the item scores in the subscale; total range: 0 to 36. A score greater than 0 indicates the difference favored sunitinib. (NCT00083889)
Timeframe: Day 1 & 28 of each cycle: duration of treatment phase

Functional Assessment of Cancer Therapy-General (FACT-G)

Functional Assessment of Cancer Therapy-General (FACT-G): core questionnaire of the Functional Assessment of Chronic Illness Therapy (FACIT) measurement system that has been validated in a variety of cancer populations. 27 questions grouped into 4 domains that measure a patient's physical, functional, social and family, and emotional well-being. Five-point Likert-type scale ranging from 0 to 4 (0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much). Score = sum score of item scores in the subscale; total range: 0 to 108 with higher score indicating better quality of life. (NCT00083889)
Timeframe: Day 1 & 28 of each cycle: duration of treatment phase

Functional Assessment of Cancer Therapy-General (FACT-G): Emotional Well Being (EWB) Subscale

Emotional well-being (EWB)subscale of the Functional Assessment of Cancer Therapy-General (FACT-G). Each question was answered on a five-point Likert-type scale ranging from 0 to 4 (0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much). Score = the sum score of the item scores in the subscale; range: 0 to 24; lower score indicates better emotional well-being. (NCT00083889)
Timeframe: Day 1 & 28 of each cycle: duration of treatment phase

Functional Assessment of Cancer Therapy-General (FACT-G): Functional Well Being (FWB) Subscale

Functional well-being (FWB) subscale of the Functional Assessment of Cancer Therapy-General (FACT-G). Each question was answered on a five-point Likert-type scale ranging from 0 to 4 (0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much). Score = the sum score of the item scores in the subscale; range: 0 to 28; higher score indicates greater functional well-being. (NCT00083889)
Timeframe: Day 1 & 28 of each cycle: duration of treatment phase

Functional Assessment of Cancer Therapy-General (FACT-G): Physical Well Being (PWB) Subscale

Physical well-being (PWB) subscale of the Functional Assessment of Cancer Therapy-General (FACT-G). Each question was answered on a five-point Likert-type scale ranging from 0 to 4 (0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much). Score = the sum score of the item scores in the subscale; range: 0 to 28; lower score indicates better physical well-being. (NCT00083889)
Timeframe: Day 1 & 28 of each cycle: duration of treatment phase

Functional Assessment of Cancer Therapy-General (FACT-G): Social/Family Well Being (SWB) Subscale

Social/family well-being (SWB)subscale of the Functional Assessment of Cancer Therapy-General (FACT-G). Each question was answered on a five-point Likert-type scale ranging from 0 to 4 (0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much). Score = the sum score of the item scores in the subscale; range: 0 to 28; lower score indicates less social/family well-being. (NCT00083889)
Timeframe: Day 1 & 28 of each cycle: duration of treatment phase

Plasma Concentrations of Soluble Proteins: Plasma Basic Fibroblast Growth Factor (bFGF) That May be Associated With Tumor Proliferation or Angiogenesis

Plasma concentrations of soluble proteins that may be associated with tumor proliferation or angiogenesis collected from a subset of patients were analyzed by enzyme-linked immunosorbent assay (ELISA) analysis. Soluble protein values: Baseline concentration (pM) and ratio to Baseline at each timepoint; ratio = plasma concentration of soluble protein (picograms per milliliter [pg/ml]) at timepoint / concentration of soluble protein (pg/ml) at baseline. Samples below the limit of quantitation and samples with insufficient volume available were excluded. (NCT00083889)
Timeframe: Day 1 & Day 28, Cycle 1 to Cycle 4

Plasma Concentrations of Soluble Proteins: Plasma VEGF-A, Plasma VEGF-C, Plasma sVEGFR-3, PLASMA IL-8, and PLASMA bFGF That May be Associated With Tumor Proliferation or Angiogenesis

Plasma concentrations of soluble proteins that may be associated with tumor proliferation or angiogenesis collected from a subset of patients were analyzed by enzyme-linked immunosorbent assay (ELISA) analysis. Soluble protein values: Baseline concentration (pM) and ratio to Baseline at each timepoint; ratio = plasma concentration of soluble protein (picograms per milliliter [pg/ml]) at timepoint / concentration of soluble protein (pg/ml) at baseline. Samples below the limit of quantitation and samples with insufficient volume available were excluded. (NCT00083889)
Timeframe: Day 1 & Day 28, Cycle 1 to Cycle 4

Duration of Response (DR)

DR: Time from first documentation of objective tumor response to first date that recurrence or progressive disease (PD) was objectively documented, taking as a reference for PD, the smallest sum LD recorded since randomization. (NCT00065468)
Timeframe: Baseline, every month until tumor progression or death (up to Month 80)

European Quality of Life Health Questionnaire (EQ-5D) - Index Score

EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. EQ-5D index measured 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Range of EQ-5D index score = -0.594 to 1 where higher scores indicated a better health state. (NCT00065468)
Timeframe: Baseline

Overall Survival (OS)

Overall survival is the duration from randomization to death. For participants who are alive, overall survival is censored at the last contact. (NCT00065468)
Timeframe: Baseline up to Month 80

Percentage of Participants With Clinical Benefit

Clinical benefit: confirmed CR or PR or had stable disease (SD) lasting at least 24 weeks. CR was the disappearance of all target lesions and non target lesions. PR was at least a 30% decrease in sum of the LD of target lesions, taking as reference the baseline sum LD. SD was having neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. (NCT00065468)
Timeframe: Baseline, every 2 months until tumor progression or death (up to Month 80)

Percentage of Participants With Objective Response

Percentage of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). CR was the disappearance of all target lesions and non target lesions. PR was at least a 30 percent (%) decrease in sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. (NCT00065468)
Timeframe: Baseline, every 2 months until tumor progression or death (up to Month 80)

Progression-Free Survival (PFS)

PFS based on Independent Central Review Assessment. The period from randomization until disease progression, death or date of last contact. (NCT00065468)
Timeframe: Baseline, monthly until tumor progression or death (up to Month 80)

Quality-adjusted Time Without Symptoms or Toxicity (Q-TWiST)

"The Q-Twist is not a score calculated for each participant but is defined only on a by treatment group basis. For each treatment group, it is the weighted sum of the mean durations of the health states Tox, Twist, and Relapse. Tox is defined as time with severe toxicity related to treatment; Twist: time without symptoms or toxic side effects; and Relapse: time after relapse/progression. The mean duration of each health state is calculated based on the area under the Kaplan Meier curve pertaining to that health state. There is no direct method for calculating the dispersion of Q-Twist, and it is typically done using bootstrap method for purposes of inference (see, e.g., Glasziou PP, Simes RJ, Gelber RD. Quality adjusted survival analysis. Stat Med 1990; 9: 1259-76). In practice, as apparently in the case with this study, the intermediate values resulting from the bootstrap exercise were not displayed." (NCT00065468)
Timeframe: Baseline to Month 80

Time to Treatment Failure (TTF)

TTF is defined as the time from the date of randomization to the date of PD or death, withdrawal from treatment due to an adverse event (AE), withdrawal of voluntary consent, or lost to follow-up, whichever occurred first, censored at the date of the conclusion of treatment phase. (NCT00065468)
Timeframe: Baseline, every month until tumor progression or death (up to Month 80)