Official Title: “Randomized, Open Label Multi-Center Study of XRP6258 in Combination With Prednisone Compared to Mitoxantrone in Combination With Prednisone For The Treatment of Hormone Refractory Metastatic Prostate Cancer Previously Treated With A Taxotere®-Containing Regimen”

This is a randomized, open-label, multi-center study comparing the safety and efficacy of XRP6258 plus prednisone to mitoxantrone plus prednisone in the treatment of hormone refractory metastatic prostate cancer previously treated with a Taxotere-containing regimen.

The primary objective is overall survival. Secondary objectives include progression free survival, overall response rate, prostate-specific antigen (PSA) response/progression, pain response/progression, overall safety, and pharmacokinetics. Patients will be treated until disease progression, death, unacceptable toxicity, or for a maximum of 10 cycles. Patients will have long-term follow-up for a maximum of up to 2 years.

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Primary:

• The primary outcome measure is overall survival defined as the time interval from the date of randomization to the date of death due to any cause.

Secondary:

• to be evaluated at screening, day 1 of every treatment cycle, end of study treatment, and in follow-up until documented progression: PSA levels
• Anti-tumor activity via Computerized Tomography / Magnetic Resonance Imaging (and bone scans, as indicated)
• Pain via an analgesic consumption score and the Present Pain Index over a one-week period
• Adverse events; laboratory abnormalities; vital signs

Inclusion Criteria

• 1. Histologically or cytologically confirmed adenocarcinoma of the prostate.
• 2. Documented progression of disease (demonstrating at least one visceral or soft tissue metastatic lesion, including a new lesion). Patients with non-measurable disease must have documented rising PSA levels or appearance of new lesion.
• 3. Surgical or hormone-induced castration
• 4. Life expectancy > 2 months
• 5. Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2

Exclusion criteria

• 1. Previous treatment with mitoxantrone
• 2. Prior radiotherapy to ≥ 40% of bone marrow
• 3. Surgery, radiation, chemotherapy, or other anti-cancer therapy within 4 weeks prior to enrollment in the study
• 4. Other prior malignancy, except for adequately treated superficial basal cell skin cancer, or any other cancer from which the patient has been disease-free for less than 5 years
• 5. Known brain or leptomeningeal involvement
• 6. Other concurrent serious illness or medical conditions
• 7. Inadequate organ function evidenced by unacceptable laboratory results
• The investigator will evaluate whether there are other reasons why a patient may not participate.

Lead Sponsor: Sanofi-Aventis

sanofi-aventis US

Bridgewater New Jersey 08807 United States

sanofi-aventis Argentina

Buenos Aires   Argentina

sanofi-aventis Belgium

Diegem   Belgium

sanofi-aventis Brazil

Sao Paulo   Brazil

sanofi-aventis Canada

Laval Quebec  Canada

sanofi-aventis Chile

Santiago   Chile

sanofi-aventis Czech Republic

Praha   Czech Republic

sanofi-aventis Denmark

Horsholm   Denmark

sanofi-aventis Finland

Helsinki   Finland

sanofi-aventis France

Paris   France

sanofi-aventis Germany

Berlin   Germany

Sanofi-Aventis Hungaria

Budapest   Hungary

sanofi-aventis India

Mumbai   India

sanofi-aventis Italy

Milano   Italy

sanofi-aventis South Korea

Seoul   Korea, Republic of

sanofi-aventis Mexico

Mexico   Mexico

sanofi-aventis Netherlands

Gouda   Netherlands

sanofi-aventis Russia

Moscow   Russian Federation

sanofi-aventis Singapore

Singapore   Singapore

sanofi-aventis Slovakia

Bratislava   Slovakia

sanofi-aventis South Africa

Midrand   South Africa

sanofi-aventis Spain

Barcelona   Spain

sanofi-aventis Sweden

Bromma   Sweden

sanofi-aventis Taiwan

Taipei   Taiwan

sanofi-aventis Turkey

Istanbul   Turkey

sanofi-aventis UK

Guildford Surrey  United Kingdom

sanofi-aventis Uruguay

Montevideo   Uruguay

Overall Clinical Trial Officials and Contacts

ICD Study Director Sanofi-Aventis  

Overall Contact: Public Registry ICD  GV-Contact-us@sanofi-aventis.com

Information obtained from ClinicalTrials.gov on July 18, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00417079

Study ID Number: EFC6193

ClinicalTrials.gov Identifier: NCT00417079

Health Authority: United States: Food and Drug Administration