prostate cancer metastatic MedDRA version: 18.0 Level: PT Classification code 10036909 Term: Prostate cancer metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: Jevtana
Product Name: Cabazitaxel
Product Code: XRP6258
Pharmaceutical Form: Concentrate and solvent for solution for infusion
INN or Proposed INN: cabazitaxel
CAS Number: 183133-96-2
Curr
Sponsors
Sanofi-aventis Groupe
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Histologically or cytologically confirmed prostate adenocarcinoma. Metastatic disease. Effective castration with serum testosterone levels =65 years) yes F.1.3.1 Number of subjects for this age range 160
Exclusion criteria
Exclusion criteria: Prior chemotherapy other than docetaxel for prostate cancer, except estramustine and except adjuvant/neoadjuvant treatment completed >3 years ago. Less than 28 days elapsed from prior treatment with chemotherapy, radiotherapy, or surgery to the time of randomization. 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] v4.0) at the time of randomization. Eastern Cooperative Oncology Group performance status (ECOG PS) >2 (ECOG 2 must be related to prostate cancer, not to other comorbidities). Prior malignancy. Adequately treated basal cell or squamous cell skin or superficial (pTis, pTa, and pT1) bladder cancer are allowed, as well as any other cancer for which treatment has been completed ?5 years ago and from which the patient has been disease-free for ?5 years. Participation in another clinical trial and any concurrent treatment with any investigational drug within 30 days prior to randomization. Acquired immunodeficiency syndrome (AIDS-related illnesses) or known HIV disease requiring antiretroviral treatment. Patients with reproductive potential who do not agree to use an accepted and effective method of contraception during the study treatment period and up to 6 months after the last administered dose. The definition of "effective method of contraception" will be based on the Investigator?s judgment. Known allergies, hypersensitivity or intolerance to prednisone or excipients of abiraterone acetate, enzalutamide, docetaxel, or polysorbate 80. Known history of mineralocorticoid excess or deficiency. History of seizure, underlying brain injury with loss of consciousness, transient ischemic attack within the past 12 months, cerebral vascular accident, brain arteriovenous malformation, brain metastases, or the use of concomitant medications that may lower the seizure threshold. Unable to swallow a whole tablet or capsule. Inadequate organ and bone marrow function as evidenced by: - Hemoglobin 1.5 × the upper limit of normal (ULN); - Total bilirubin >1.0 × ULN; - Potassium 2 (NCI CTCAE v4.0). Uncontrolled severe illness or medical condition including uncontrolled diabetes mellitus, history of cardiovascular disease (uncontrolled hypertension, arterial thrombotic events in the past 6 months, congestive heart failure, severe or unstable angina pectoris, recent myocardial infarction within the last 6 months, or uncontrolled cardiac arrhythmia).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the radiographic progression-free survival (rPFS) of chemotherapy (cabazitaxel plus prednisone, Arm A) versus AR-targeted therapy (enzalutamide or abiraterone acetate plus prednisone, Arm B) in mCRPC patients who have been treated with docetaxel and who had disease progression while receiving AR-targeted therapy within 6 months of AR treatment initiation (?6 months, either before or after docetaxel).;Secondary Objective: To compare efficacy for: - Prostate-specific antigen (PSA) response rate and time to PSA progression (TTPP). - Progression-free survival (PFS). - Overall survival (OS). - Tumor response rate and duration of tumor response. - Pain response and time to pain progression. - Symptomatic skeletal event (SSE) rate and time to occurrence of any SSE. - Health status. To evaluate the correlation of a signature of resistance to AR-targeted agents with clinical outcome via the analysis of circulating tumor cell (CTC) phenotypes as well as expression and localization of proteins including AR isoforms in CTCs. To evaluate safety in the 2 treatment arms.;Primary end point(s): a) Radiographic progression-free survival defined as the time from randomization to the occurrence of radiological tumor progressions using RECIST 1.1 and PCWG2 criteria b) Radiographic progression-free survival defined as the time from randomization to the occurrence of death due to any cause;Timepoint(s) of evaluation of this end point: a) up to 2 years b) up to 2 years | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): a) Number of patients achieving PSA decline >=50% b) Progression-free survival-Time c) Overall survival defined as the time interval from the date of randomization to the date of death due to any cause d) Time to PSA progression defined as the time interval between the date of randomization and the date of PSA progression using PCWG2 definition e) Number of patients achieving tumor response f) Duration of tumor response g) Pain response using Brief Pain Inventory-Short Form (BPI-SF) for pain intensity score h) Time to pain progression i) Symptomatic skeletal event (SSE) rate l) Number of treatment-emergent adverse events (TEAEs);Timepoint(s) of evaluation of this end point: a), b) : up to 2 years c) up to 2 years post treatment d), e), f), g), h), i) : up to 2 years l) Up to 30 days after the last treatment administration | — |
Countries
Austria, Belgium, Czech Republic, France, Greece, Iceland, Ireland, Italy, Netherlands, Spain
Contacts
Public ContactUnidad Estudios Clínicos
sanofi-aventis, s.a.
Outcome results
None listed