Cabazitaxel at 20 mg/m² compared to 25mg/m² with Prednisone for the treatment of Metastatic Castration Resistant Prostate Cancer
- Conditions
- metastatic Castration Resistant Prostate CancerMedDRA version: 17.0Level: PTClassification code 10060862Term: Prostate cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
- Registration Number
- EUCTR2010-022163-35-DE
- Lead Sponsor
- sanofi-aventis R&D
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Male
- Target Recruitment
- 1200
1.Diagnosis of histologically or cytologically proven prostate adenocarcinoma, 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 or antagonist with or without antiandrogen, antiandrogen withdrawal, monotherapy with estramustine, or other hormonal agents.
I 04. 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).
I 05. Age =18 years (or country's legal age of majority if the legal age is > 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
1.Previous treatment with mitoxantrone or cabazitaxel
2.Prior isotope therapy, whole pelvic radiotherapy, or radiotherapy to >30% of bone marrow.
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 (NYHA III or IV) 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 severe (> grade 2) hypersensitivity to docetaxel, or polysorbate 80.
14.Inadequate organ and bone marrow function
15.Contraindications to the use of corticosteroid treatment.
16.Symptomatic peripheral neuropathy grade > 2
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.<br>* To compare efficacy of cabazitaxel at 20 mg/m² and 25 mg/m² for:<br>* Progression Free Survival (PFS) <br>*To compare Health-related Quality of Life (HRQL)<br>* To assess the pharmacokinetics and pharmacogenomics of cabazitaxel<br>* Biomarker studies<br><br>;Primary end point(s): Overall survival (OS) ;Timepoint(s) of evaluation of this end point: Every 12 weeks until study cut off date
- Secondary Outcome Measures
Name Time Method Secondary end point(s): - Progression-free survival<br>- Tumor response in patients with measurable disease (RECIST)<br>- PSA response<br>- PSA Progression<br>- Pain response<br>- Pain Progression<br>- Health-Related Quality of Life (HRQL)<br>- Safety <br>- Pharmacokinetics and pharmacogenomics<br>- Biomarkers assessment;Timepoint(s) of evaluation of this end point: Every 3, 6 or 12 weeks depending on study phase (study treatment or follow ups) and endpoint.