mitoxantrone and Androgen-Independent Prostatic Cancer

mitoxantrone has been researched along with Androgen-Independent Prostatic Cancer in 25 studies

Mitoxantrone: An anthracenedione-derived antineoplastic agent.
mitoxantrone : A dihydroxyanthraquinone that is 1,4-dihydroxy-9,10-anthraquinone which is substituted by 6-hydroxy-1,4-diazahexyl groups at positions 5 and 8.

Research

Studies (25)

Authors

Clinical Trials (4)

Trial Overview

Trial Outcomes

Overall Survival

"Overall survival was defined as the time interval from the date of randomization to the date of death due to any cause.~In the absence of confirmation of death, the survival time was censored at the last date patient was known to be alive or at the cut-off date, whichever had come first." (NCT00417079)
Timeframe: From the date of randomization up to 104 weeks (study cut-off)

Overall Tumor Response

"Tumor Overall Response Rate (ORR) (only in patients with measurable disease):~Objective responses (Complete Response and Partial Response) for measurable disease as assessed by investigators according to RECIST criteria.~Complete Response (CR) is defined as: Disappearance of all target lesions. Partial Response (PR) is defined as: At least a 30% decrease in the sum of longest diameter (LD) of target lesions taking as reference baseline sum LD.~Confirmation of objective responses will be performed by repeat tumor imaging (CT scans, MRI, bone scans) after the first documentation of response." (NCT00417079)
Timeframe: From the date of randomization up to 104 weeks (study cut-off)

Pain Response

Pain Response was defined as a two-point or greater reduction from baseline median Present Pain Intensity (PPI) score without an increased Analgesic Score (AS) or a decrease of ≥50% in the AS without an increase in the PPI score, maintained for at least 3 weeks. (NCT00417079)
Timeframe: from baseline up to 104 weeks (study cut-off)

PSA (Prostate-Specific Antigen) Response

PSA response was defined as a ≥ 50% reduction in serum PSA, determined only for patients with a serum PSA ≥ 20ng/mL at baseline, confirmed by a repeat PSA ≥ 3 weeks later. (NCT00417079)
Timeframe: from baseline up to 104 weeks (study cut-off)

Time to Pain Progression

"Pain Progression is defined as an increase of ≥1 point in the median Personal Pain Intensity (PPI) from its nadir noted on 2 consecutive 3-week-apart visits or ≥25 % increase in the mean analgesic score compared with the baseline score & noted on 2 consecutive 3-week-apart visits or requirement for local palliative radiotherapy.~Evaluation of the PPI & analgesic scores are based on the short-form McGill Pain Questionnaire which consists of 15 descriptors (11 sensory; 4 affective) which are rated on an intensity scale as 0=none (best) 1=mild 2=moderate 3=severe (worst) (TOTAL: 0=best 45=worst)" (NCT00417079)
Timeframe: from baseline up to 104 weeks (study cut-off)

Time to Progression Free Survival (PFS)

Progression free survival was defined as a composite endpoint evaluated from the date of randomization to the date of tumor progression, PSA progression, pain progression, or death due to any cause, whichever occurred first (NCT00417079)
Timeframe: From the date of randomization up to 104 weeks (study cut-off)

Time to Prostatic Specific Antigen (PSA) Progression

"In PSA non-responders, progression will be defined as a 25% increase over nadir and increase in the absolute value PSA level by at least 5 ng/ml and confirmed by a second value at least 4 weeks later.~In PSA responders and in patients not evaluable for PSA response at baseline, progression will be defined as a ≥50% increase over nadir, provided that the increase is a minimum of 5 ng/ml and confirmed by a second value at least 1 week later." (NCT00417079)
Timeframe: at screening, day 1 of every treatment cycle, up to 104 weeks (study cut-off)

Time to Tumor Progression

Time to tumor progression is defined as the number of months from randomization until evidence of progressive disease (RECIST) (NCT00417079)
Timeframe: From the date of randomization up to 104 weeks (study cut-off)

Composite Progression-free Survival (cPFS)

"Defined as the median time from randomization to the earliest of:~Tumor progression by Response Evaluation Criteria in Solid Tumors (RECIST);~Evidence of progression by bone scan, performed after completion of the first 3 cycles, demonstrating the appearance of >=2 new lesions;~New skeletal events (New pathologic bone fracture in the region of metastatic disease; New bone lesion requiring radiation or surgery; Spinal cord or nerve root compression)~Symptomatic progression (for participants without measurable disease);~Other clinical events attributable to prostate cancer that require major interventions; or~Death from any cause~Participants who were ongoing with no progression or who discontinued treatment for reasons other than progression were censored at date of last assessment. Participants who started new anticancer treatment before progression were censored at date of last assessment before start of new anti-cancer therapy." (NCT00683475)
Timeframe: Randomization to composite progressive disease, up to 23.4 months

Composite Progression-free Survival (cPFS) at 12-months

"Data presented are the percentage of participants without disease progression at 12 months.~Participants who were ongoing with no progression or who discontinued treatment for reasons other than progression were censored at date of last assessment. Participants who started new anticancer treatment before progression were censored at date of last assessment before start of new anti-cancer therapy." (NCT00683475)
Timeframe: 12 months

Composite Progression-free Survival (cPFS) at 6-months

"Data presented are the percentage of participants without disease progression at 6 months.~Participants who were ongoing with no progression or who discontinued treatment for reasons other than progression were censored at date of last assessment. Participants who started new anticancer treatment before progression were censored at date of last assessment before start of new anti-cancer therapy." (NCT00683475)
Timeframe: 6 months

Composite Progression-free Survival (cPFS) at 9-months

"Data presented are the percentage of participants without disease progression at 9 months.~Participants who were ongoing with no progression or who discontinued treatment for reasons other than progression were censored at date of last assessment. Participants who started new anticancer treatment before progression were censored at date of last assessment before start of new anti-cancer therapy." (NCT00683475)
Timeframe: 9 months

Objective Response Rate (ORR)

"Objective response is Complete Response (CR) + Partial Response (PR), as classified by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST) guidelines. CR is a disappearance of all target and non-target lesions; PR is at least a 30% decrease in the sum of the longest diameter of target lesions without new lesions and progression of non-target lesions.~Objective response rate is calculated as a total number of participants with CR or PR divided by the total number of participants with measurable disease, multiplied by 100." (NCT00683475)
Timeframe: Baseline to date of progressive disease or death up to 36.3 months

Overall Survival (OS)

Overall survival is defined as the time from randomization to the date of death due to any cause. Participants who were alive at the time of study completion were censored at the time the participant was last known to be alive. (NCT00683475)
Timeframe: First dose to death due to any cause up to 36.3 months

Prostate Specific Antigen (PSA) Response Rate

PSA response rate is defined as the percentage of participants with a decrease in PSA >= 50 percent from baseline. (NCT00683475)
Timeframe: Baseline up to data cut-off date (up to 36.3 months)

Time to Radiographic Evidence of Disease Progression

"Time between date of randomization and earliest date of radiographic progression defined as either:~Tumor progression by RECIST;~Evidence of progression by bone scan;~New skeletal events (New pathologic bone fracture in the region of metastatic disease; New bone lesion requiring radiation or surgery; Spinal cord or nerve root compression).~Participants who were ongoing with no radiographic evidence of disease progression, who discontinued treatment for reasons other than progression,or died before progression were censored at date of last tumor or bone radiographic assessment. Participants who started a new anticancer treatment before progression were censored at date of last tumor or bone radiographic assessment before start of new anti-cancer therapy." (NCT00683475)
Timeframe: Randomization to date of radiographic progression, up to 36.3 months

Summary Listing of Participants Reporting Treatment-Emergent Adverse Events

Data presented are the number of participants who experienced A12 or 1121B (ramucirumab) related treatment-emergent adverse events (TEAE), treatment related serious adverse events (SAE), or any Grade 3 or higher TEAE; any TEAE leading to discontinuation of A12 or 1121B (ramucirumab) treatment, and any TEAE leading to dose modification of A12 or 1121B (ramucirumab). A summary of SAEs and other nonserious AEs, regardless of causality, is located in the Reported Adverse Event section. (NCT00683475)
Timeframe: Randomization to 36.3 months

Reviews

6 reviews available for mitoxantrone and Androgen-Independent Prostatic Cancer

Trials

14 trials available for mitoxantrone and Androgen-Independent Prostatic Cancer

Other Studies

5 other studies available for mitoxantrone and Androgen-Independent Prostatic Cancer