XRP6258 Plus Prednisone Compared to Mitoxantrone Plus Prednisone in Hormone Refractory Metastatic Prostate Cancer

Condition(s) targeted: Neoplasms; Prostatic Neoplasms

Intervention: XRP6258 (RPR116258) (Drug); mitoxantrone (Drug); prednisone (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Sanofi-Aventis

Official(s) and/or principal investigator(s):
ICD, Study Director, Affiliation: Sanofi-Aventis

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

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.

Official title: A Randomized, Open Label Multi-Center Study of XRP6258 in Combination With Prednisone Every 3 Weeks Compared to Mitoxantrone in Combination With Prednisone For The Treatment of Hormone Refractory Metastatic Prostate Cancer Previously Treated With A Taxotere®-Containing Regimen

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

Primary outcome: overall survival defined as the time interval from the date of randomization to the date of death due to any cause.

Secondary outcome:

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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Male.

Criteria:

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.

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

sanofi-aventis Argentina, Buenos Aires, Argentina; Recruiting
Email: GV-Contact-us@sanofi-aventis.com

sanofi-aventis Belgium, Diegem, Belgium; Recruiting
Email: GV-Contact-us@sanofi-aventis.com

sanofi-aventis Brazil, Sao Paulo, Brazil; Recruiting
Email: GV-Contact-us@sanofi-aventis.com

sanofi-aventis Chile, Santiago, Chile; Recruiting
Email: GV-Contact-us@sanofi-aventis.com

sanofi-aventis Czech Republic, Praha, Czech Republic; Recruiting
Email: GV-Contact-us@sanofi-aventis.com

sanofi-aventis Denmark, Horsholm, Denmark; Recruiting
Email: GV-Contact-us@sanofi-aventis.com

sanofi-aventis Finland, Helsinki, Finland; Recruiting
Email: GV-Contact-us@sanofi-aventis.com

sanofi-aventis France, Paris, France; Recruiting
Email: GV-Contact-us@sanofi-aventis.com

sanofi-aventis Germany, Berlin, Germany; Recruiting
Email: GV-Contact-us@sanofi-aventis.com

Sanofi-Aventis Hungaria, Budapest, Hungary; Recruiting
Email: GV-Contact-us@sanofi-aventis.com

sanofi-aventis India, Mumbai, India; Recruiting
Email: GV-Contact-us@sanofi-aventis.com

sanofi-aventis Italy, Milano, Italy; Recruiting
Email: GV-Contact-us@sanofi-aventis.com

sanofi-aventis South Korea, Seoul, Korea, Republic of; Recruiting
Email: GV-Contact-us@sanofi-aventis.com

sanofi-aventis Mexico, Mexico, Mexico; Recruiting
Email: GV-Contact-us@sanofi-aventis.com

sanofi-aventis Netherlands, Gouda, Netherlands; Recruiting
Email: GV-Contact-us@sanofi-aventis.com.

sanofi-aventis Russia, Moscow, Russian Federation; Recruiting
Email: GV-Contact-us@sanofi-aventis.com

sanofi-aventis Singapore, Singapore, Singapore; Recruiting
Email: GV-Contact-us@sanofi-aventis.com

sanofi-aventis Slovakia, Bratislava, Slovakia; Recruiting
Email: GV-Contact-us@sanofi-aventis.com

sanofi-aventis South Africa, Midrand, South Africa; Recruiting
Email: GV-Contact-us@sanofi-aventis.com

sanofi-aventis Spain, Barcelona, Spain; Recruiting
Email: GV-Contact-us@sanofi-aventis.com

sanofi-aventis Sweden, Bromma, Sweden; Recruiting
Email: GV-Contact-us@sanofi-aventis.com

sanofi-aventis Taiwan, Taipei, Taiwan; Recruiting
Email: GV-Contact-us@sanofi-aventis.com

sanofi-aventis Turkey, Istanbul, Turkey; Recruiting
Email: GV-Contact-us@sanofi-aventis.com

sanofi-aventis Uruguay, Montevideo, Uruguay; Recruiting
Email: GV-Contact-us@sanofi-aventis.com

sanofi-aventis US, Bridgewater, New Jersey 08807, United States; Recruiting
Email: GV-Contact-us@sanofi-aventis.com

sanofi-aventis Canada, Laval, Quebec, Canada; Recruiting
Email: GV-Contact-us@sanofi-aventis.com

sanofi-aventis UK, Guildford, Surrey, United Kingdom; Recruiting
Email: GV-Contact-us@sanofi-aventis.com

Starting date: December 2006
Ending date: May 2010
Last updated: August 29, 2008