pteridines and Metastase

pteridines has been researched along with Metastase in 7 studies

Research

Studies (7)

Authors

Clinical Trials (3)

Trial Overview

Trial Outcomes

AUC0-∞ of Volasertib

Area under the concentration-time curve in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) of volasertib (NCT01023958)
Timeframe: 5 mins before start of drug infusion and 2h, 3h, 6h, 24h, 168h and 336h after start of drug infusion

CL of Volasertib

Total plasma clearance after intravascular administration (CL) of volasertib (NCT01023958)
Timeframe: 5 mins before start of drug infusion and 2h, 3h, 6h, 24h, 168h and 336h after start of drug infusion

Cmax of Volasertib

Maximum measured concentration in plasma (Cmax) of volasertib (NCT01023958)
Timeframe: 5 mins before start of drug infusion and 2h, 3h, 6h, 24h, 168h and 336h after start of drug infusion

Disease Control Rate

Disease control rate. Disease control is defined as having a best overall response of complete response (CR), partial response (PR) or stable disease (SD). (NCT01023958)
Timeframe: From first drug administration until end of study, up to 2 years

Duration of Disease Control

Disease control is defined as having a best overall response of CR, PR, or SD. The duration of disease control is measured from the time of first response to progression or death whichever occurs first. (NCT01023958)
Timeframe: Time of first response to progression or death, up to 2 years

Duration of Overall Response

The duration of overall response is measured from the time of first response (CR or PR) to progression or death whichever occurs first. (NCT01023958)
Timeframe: From the time of first response (CR or PR) to progression or death, up to 2 years

Laboratory Investigation: Alkaline Phosphatase

Difference from baseline in laboratory parameter Alkaline phosphatase (NCT01023958)
Timeframe: Baseline and last value on treatment (up to 2 years)

Laboratory Investigation: ALT/GPT, SGPT

Difference from baseline in laboratory parameter Alanine aminotransferase(ALT)/GPT, SGPT (NCT01023958)
Timeframe: Baseline and last value on treatment (up to 2 years)

Laboratory Investigation: AST/GOT, SGOT

Difference from baseline in laboratory parameter Aspartate aminotransferase(AST)/GOT, SGOT (NCT01023958)
Timeframe: Baseline and last value on treatment (up to 2 years)

Laboratory Investigation: Creatinine

Difference from baseline in laboratory parameter Creatinine (NCT01023958)
Timeframe: Baseline and last value on treatment (up to 2 years)

Laboratory Investigation: Haemoglobin

Difference from baseline in laboratory parameter Haemoglobin (NCT01023958)
Timeframe: Baseline and last value on treatment (up to 2 years)

Laboratory Investigation: Lymphocytes

Difference from baseline in laboratory parameter Lymphocytes (NCT01023958)
Timeframe: Baseline and last value on treatment (up to 2 years)

Laboratory Investigation: Neutrophils

Difference from baseline in laboratory parameter Neutrophils (NCT01023958)
Timeframe: Baseline and last value on treatment (up to 2 years)

Laboratory Investigation: Platelets

Difference from baseline in laboratory parameter Platelets (NCT01023958)
Timeframe: Baseline and last value on treatment (up to 2 years)

Laboratory Investigation: Total Bilirubin

Difference from baseline in laboratory parameter total Bilirubin (NCT01023958)
Timeframe: Baseline and last value on treatment (up to 2 years)

Laboratory Investigation: White Blood Cell Count

Difference from baseline in laboratory parameter white blood cell count (NCT01023958)
Timeframe: Baseline and last value on treatment (up to 2 years)

Objective Tumour Response According to RECIST Criteria

Objective tumor response, defined as complete response (CR) or partial response (PR), according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria. (NCT01023958)
Timeframe: From first drug administration until end of study, up to 2 years

Occurrence of Unacceptable Toxicity

Occurrence of unacceptable toxicity is defined by CTCAE as as drug related CTCAE Grade 3 or greater non-hematological toxicity (except emesis or diarrhea responding to supportive treatment); drug-related CTCAE Grade 4 neutropenia for seven or more days and / or complicated by infection; or drug-related CTCAE Grade 4 thrombocytopenia. (NCT01023958)
Timeframe: From first drug administration up to 21 days after final administration, up to 2 years

Overall Survival

"Overall survival (OS) is the time from first infusion to death. Patients who were alive at the time of analysis or lost to follow-up were censored at the last follow-up date when they were known to be alive.~Overall survival was analyzed with the Kaplan-Meier curve. Greenwood's variance estimate was used to form confidence intervals." (NCT01023958)
Timeframe: Time from first infusion to death, up to 2 years

Progression-free Survival

"Progression-free survival (PFS) is the time from first treatment to the occurrence of tumor progression or death, whichever occurs first. Disease progression is defined according to the RECIST guideline but also includes the investigators' assessment which may, in some cases, include only clinical progression (deterioration of general health status per investigator). PFS was analyzed with the Kaplan-Meier curve. Greenwood's variance estimate was used to form confidence intervals.~Patients without evidence of disease progression were to be censored at the last image date." (NCT01023958)
Timeframe: Time from first treatment to the occurrence of tumor progression or death, up to 2 years

t1/2 of Volasertib

Terminal half-life (t1/2) of volasertib (NCT01023958)
Timeframe: 5 mins before start of drug infusion and 2h, 3h, 6h, 24h, 168h and 336h after start of drug infusion

Tmax of Volasertib

Time from dosing to maximum measured concentration (Tmax) of volasertib (NCT01023958)
Timeframe: 5 mins before start of drug infusion and 2h, 3h, 6h, 24h, 168h and 336h after start of drug infusion

Vss of Volasertib

Apparent volume of distribution at steady state following intravascular administration (Vss) of volasertib (NCT01023958)
Timeframe: 5 mins before start of drug infusion and 2h, 3h, 6h, 24h, 168h and 336h after start of drug infusion

Occurrence and Intensity of AE's Graded According to CTCAE

"Occurrence and intensity of adverse events (AEs) graded according to Common Toxicity Criteria of Adverse Events (CTCAE).~The CTCAE grades are: 1 (mild AE), 2 (moderate AE), 3 (severe AE), 4 (life-threatening or disabling AE), 5 (death related to AE)." (NCT01023958)
Timeframe: From first drug administration until end of study, up to 2 years

Number of Participants With Dose Limiting Toxicities (DLT)

MTD was defined on the basis of DLTs occuring during Cycle 1 of the dose escalation part in each of the 2 treatment schedules. DLTs were defined as drug related based on Common Terminology Criteria for AE's (CTCAE) Grade(G) :1) G4 neutropenia (ANC, including bands, <500/mm³) for more than 7 days, 2) G3 or 4 neutropenia associated with fever >38.5° C (febrile neutropenia),3) Neutropenic infection G ≥3, 4) G4 thrombocytopenia or G3 thrombocytopenia associated with bleeding requiring whole blood transfusion.5) Non-haematological G ≥3 toxicity excluding: (a) untreated G3 diarrhoea, (b) untreated G3 nausea and/or vomiting, (c) untreated G3 rash. 6) G2 increase in AST and/or ALT in conjunction with an elevated bilirubin level of G ≥2, 7) G2 nausea and/or vomiting despite optimal supportive/antiemetic treatment for at least 7consecutive days. 8) G2 diarrhoea for 2 or more consecutive days despite antidiarrhoeal medication/hydration, 9) Decrease in left ventricular function G ≥2. (NCT01206816)
Timeframe: 22 Days

Number of Patients With Drug-related Adverse Events According to Common Terminology Criteria for Adverse Events (CTCAE) Criteria v 3.0

Number of patients with investigator defined drug-related adverse events according to Common Terminology Criteria for Adverse Events (CTCAE) criteria v 3.0 (NCT01206816)
Timeframe: After the first drug administration until 28 days after the last drug administration, up to 413 days.

Maximum Tolerable Dose (MTD) of Two Combination Therapy of Volasertib and Afatinib.

"Maximum Tolerable Dose (MTD) was determined by dose escalation for volasertib and afatinib. The 3 + 3 design with de-escalation for both the Schedules A and B. Patients were sequentially allocated to the dose cohorts. Apart from allocation to the treatment schedules, escalation and/or de-escalation to determine the MTD occurred independently within the 2 dose schedules. Cohorts of 3 patients were to be treated at the starting dose levels according to the treatment schedule. Before entering patients at a higher dose level, all patients at the previous dose level combination had to complete at least the initial cycle of 21 days." (NCT01206816)
Timeframe: MTD was assessed during the first cycle of combination of Volasertib and Afatinib therapy (22 days)

Number of Patients With Best Overall Response.

"Best overall response based on response evaluation criteria in solid tumors (RECIST) version 1.1. Best overall response is defined as complete response, partial response, stable disease, progressive disease or not evaluable.~As Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by using appropriate radiology techniques: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; progression, as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression." (NCT01206816)
Timeframe: Tumor assessment was performed at screening and at the end of every 3 treatment cycle (ie every 9 weeks of treatment).

Number of Patients With Disease Control

"Disease control based on response evaluation criteria in solid tumors (RECIST) version 1.1. Patients who had a best overall tumour response of complete response (CR), partial response (PR) or stable disease (SD) were assessed to show disease control.~As Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by using appropriate radiology techniques: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression." (NCT01206816)
Timeframe: Tumor assessment was performed at screening and at the end of every 3 treatment cycle (ie every 9 weeks of treatment).

Number of Patients With Objective Response (OR)

"Objective tumor response based on response evaluation criteria in solid tumors (RECIST) version 1.1. OR is defined as complete response (CR) or partial response (PR).~As Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by using appropriate radiology techniques: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions." (NCT01206816)
Timeframe: Tumor assessment was performed at screening and at the end of every 3 treatment cycle (ie every 9 weeks of treatment).

Trials

3 trials available for pteridines and Metastase

Other Studies

4 other studies available for pteridines and Metastase