Randomized, Open Label, Multi-Center Study comparing Cabazitaxel at 25 mg/m2 and at 20 mg/m² in Combination with Prednisone Every 3 Weeks to Docetaxel in Combination with Prednisone in Patients with Metastatic Castration Resistant Prostate Cancer not Pretreated with Chemotherapy - FIRSTANA

sanofi-aventis R&D0 sites1,170 target enrollmentMay 26, 2011

Overview

No summary available.

Registry

who.int

Start Date

May 26, 2011

End Date

TBD

Last Updated

7 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

Male

Sponsor

sanofi-aventis R&D

•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

•\* 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.