Basic Trial Information
Trial Description
     Summary
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Completed 18 and over Pharmaceutical / Industry EFC5378 SR31747A, NCT00174863

Trial Description

Summary

To evaluate the efficacy of SR31747 given at 75 or 125mg per day versus placebo in androgen prostate cancer patient without distant metastases with Time to Clinical progression as main objective and PSA parameters, Tumor response, survival , safety,Tumor-related symptoms deterioration Quality of Life, PK analysis as secondary objectives

Eligibility Criteria

Inclusion Criteria:

• Prior confirmed histological diagnosis of prostatic carcinoma.

• Rising PSA while receiving hormonal therapy or after surgical castration defined as 2 sequential increases above a previous lowest reference value within the past 12 months; PSA must be at least 4ng/ml at the time of study entry.

• No distant metastases as evidenced by bone scan (+ or - centered X-Ray or MRI), and spiral thoracoabdominopelvic CT scan.

• Effective castration throughout the study. Any prior anti-androgen therapy should be stopped with documented continued elevation of PSA 4 weeks after the cessation of flutamide (6 weeks for bicalutamide).

• Serum testosterone levels < 50ng/dL at the time of progression and throughout the study.

• Age > or = to 18 years.

• Extensive metabolizer by CYP2D6 genotyping.

• Karnofsky Performance Status > or = to 70% and life expectancy > 6 months.

• Adequate hematological, renal and liver function.

• Signed written informed consent

Exclusion Criteria:

• Poor metabolizers by CYP2D6 genotyping.

• Prior palliative radiotherapy or any prior chemotherapy or experimental therapy.

• More than one line of any prior anticancer treatment with estrogen (estrogen or estramustine) if discontinued at least 4 weeks before study entry.

• Concomitant administration of biphosphonate or chronic corticosteroids.

• Presence of progressive symptoms not adequately controlled with non opioid medications

• Concomitant use of medications known to be cytochrome P450 2D6 inhibitors as listed in protocol appendice

• Previous malignancies except if there has been a disease-free interval of at least 5 years and except curatively treated non-melanoma skin cancer

• Other serious illness or medical condition, which would not permit the patient to be managed according to the protocol.

Trial Contact Information

Trial Lead Organizations/Sponsors

Sanofi-Aventis - US - Bridgewater

B. TOMBAL, MD

Study Chair

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00174863
Information obtained from ClinicalTrials.gov on May 27, 2008