metastatic Castration Resistant Prostate Cancer
Conditions
Interventions
Trade Name: JEVTANA
Product Name: cabazitaxel
Product Code: XRP6258
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Cabazitaxel
CAS Number: 183133-96-2
Concentration un
Sponsors
sanofi-aventis R&D
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1.Diagnosis of histologically or cytologically proven prostate adenocarcinoma, that is resistant to hormone therapy and previously treated with a docetaxel-containing regimen. Patient must have documented progression of disease during or within 6 months after prior hormone therapy and disease progression during or after docetaxel-containing therapy. 2.Patient must have either measurable or non-measurable disease. 3.Received prior castration by orchiectomy and/or Luteinizing Hormone-Releasing Hormone (LH-RH) agonist with or without antiandrogen, antiandrogen withdrawal, monotherapy with estramustine, or other hormonal agents. 4.Life expectancy > 6 months 5.Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 – 2 (ie, patient must be ambulatory, capable of all self-care, and up and about more than 50% of waking hours) 6.Age =18 years 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: 1.Previous treatment with mitoxantrone or cabazitaxel 2.Prior isotope therapy or radiotherapy to =30% of bone marrow. In case of prior isotope therapy 12 weeks must have elapsed prior to first study drug administration. 3.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. 4.Prior surgery, radiation, chemotherapy, or other anti-cancer therapy within 4 weeks prior to enrollment in the study 5.Prior malignancy. Adequately treated basal cell or squamous cell skin or in situ bladder cancer are allowed, as well as any other cancer for which chemotherapy has been completed = 5 years ago and from which the patient has been disease-free for = 5 years 6.Participation in another clinical trial and any concurrent treatment with any investigational drug within 30 days prior to randomization. 7.Known brain or leptomeningeal involvement 8.Other concurrent serious illness or medical conditions 9.Uncontrolled cardiac arrhythmias, angina pectoris, and/or hypertension. History of congestive heart failure or myocardial infarction within last 6 months is also not allowed. 10.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. 11.Absence of signed and dated Institutional Review Board (IRB)-approved patient informed consent form prior to enrollment into the study. 12.Patients with reproductive potential who do not agree to use accepted and effective method of contraception during the study treatment period. The definition of “effective method of contraception” will be based on the investigator’s judgment. Patients' Partners of childbearing potential (unless surgically sterile, post menopausal or for another reason have no chance of becoming pregnant) not protected by highly effective contraceptive method of birth control as defined for contraception in the Informed Consent Form and /or in a local protocol addendum. Related to chemotherapy 13.History of hypersensitivity to docetaxel, or polysorbate 80. 14.Inadequate organ and bone marrow function as evidenced by: a.Hemoglobin 1.5 x ULN; e.Total bilirubin > 1.0 x ULN f.Serum Creatinine > 1.5 x ULN. If creatinine 1.0 - 1.5 x ULN, creatinine clearance will be calculated either according to Cockcroft-Gault formula for patients younger than 65 years or, according to aMDRD formula for patients = 65 years) Creatinine clearance 2 (National Cancer Institute Common Terminology Criteria [NCI CTCAE] v.4.03).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate the non inferiority in term of overall survival (OS) of cabazitaxel 20 mg/m² (Arm A) versus cabazitaxel 25 mg/m² (Arm B) in combination with prednisone in patients with metastatic castration resistant prostate (MCRPC) previously treated with a docetaxel-containing regimen;Secondary Objective: * To evaluate safety in the 2 treatment arms and to assess if cabazitaxel 20 mg/m² is better tolerated than cabazitaxel 25 mg/m². * To compare efficacy of cabazitaxel at 20 mg/m² and 25 mg/m² 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), PSA progression, pain progression or death due to any cause - PSA-Progression - Pain progression - Tumor response in patients with measurable disease (RECIST 1.1). - PSA response - Pain response in patients with stable pain at baseline. * To compare Health-related Quality of Life (HRQL) * To assess the pharmacokinetics of cabazitaxel ;Primary end point(s): Overall survival (OS) defined as the time interval from the date of randomization to the date of death due to any cause | — |
Countries
Belgium, France, Germany, Hungary, Netherlands, Poland, Spain, United Kingdom
Outcome results
None listed