Cabazitaxel versus Docetaxel both with Prednisone in Patients with Metastatic Castration Resistant Prostate Cancer

• Conditions: metastatic Castration Resistant Prostate cancer; MedDRA version: 14.1Level: PTClassification code 10060862Term: Prostate cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2010-022064-12-PT
• Lead Sponsor: sanofi-aventis R&D

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-04-15
• Last Update Posted: 11 January 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 1170

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

* 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified