metastatic Castration Resistant Prostate cancer MedDRA version: 14.1 Level: PT Classification code 10060862 Term: Prostate cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: JEVTANA 60mg
Product Name: cabazitaxel
Product Code: XRP6258
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: cabazitaxel
CAS Number: 183 133-96-2
Current Sp
Sponsors
sanofi-aventis R&D
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1.Histologically- or cytologically-confirmed prostate adenocarcinoma. 2.Metastatic disease. 3.Progressive disease while receiving hormonal therapy or after surgical castration documented. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: * Prior chemotherapy for prostate cancer, * Less than 28 days elapsed from prior treatment with estramustine, radiotherapy or surgery to the time of randomization. . * Prior isotope therapy, whole pelvic radiotherapy, or radiotherapy to > 30% of bone marrow. * Adverse events (excluding alopecia and those listed in the specific exclusion criteria) from any prior anticancer therapy of grade >1(National Cancer Institute Common Terminology Criteria [NCI CTCAE] v4.03) at the time of randomization. * Less than 18 years (or country's legal age of majority if the legal age is > 18 years). * Eastern Cooperative Oncology Group (ECOG) performance status > 2. leptomeningeal disease. * Participation in another clinical trial and any concurrent treatment with any investigational drug within 30 days prior to randomization. 13.Any severe acute or chronic medical condition which could impair the ability of the patient to participate to the study or interfere with interpretation of study results or patients unable to comply with the study procedures. 14.Absence of signed and dated Institutional Review Board (IRB)-approved patient informed consent form prior to enrollment into the study. * Patients with reproductive potential who do not agree to use accepted and effective method of contraception during the study treatment period. * Inadequate organ and bone marrow function.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate the superiority of cabazitaxel plus prednisone at 25 mg/m² (Arm A) or 20 mg/m² (Arm B) versus docetaxel plus prednisone (Arm C) in term of overall survival (OS) in patients with metastatic castration resistant prostate cancer (MCRPC) and not previously treated with chemotherapy;Secondary Objective: * Evaluate safety in the 3 treatment arms * Compare efficacy of cabazitaxel at 20 mg/m² and 25 mg/m² to docetaxel for: - Progression Free Survival (PFS) defined as the first occurrence of any of the following events: tumor progression per Response Evaluation Criteria In Solid Tumors (RECIST 1.1), PSA progression, pain progression or death due to any cause - Time to occurrence of any skeletal related events (SRE). * To compare Health-Related Quality of Life (HRQL) * To assess the pharmacokinetic and pharmacogenomics of cabazitaxel- ;Primary end point(s): OS defined as the time interval from the date of randomization to the date of death due to any cause;Timepoint(s) of evaluation of this end point: Every 12 weeks until study cut off date | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Progression-free survival - Tumor response in patients with measurable disease (RECIST) - PSA response - PSA Progression - Pain response - Pain Progression - Health-Related Quality of Life (HRQL) - Related skeletal events - Safety (NCI-CTC version 4.03) - Pharmacokinetics and pharmcogenomics - Biomarkers;Timepoint(s) of evaluation of this end point: every 12 weeks for radiological assessment each visit for safety, biology and patient questionnaires | — |
Countries
Brazil, Canada, Czech Republic, Denmark, European Union, Finland, Germany, Israel, Italy, Mexico, Peru, Poland, Portugal, Russian Federation, Spain, Sweden, Taiwan, Turkey
Outcome results
None listed