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”

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

Study Primary Completion Date: May 2010

Intervention(s) in this Clinical Trial

• Drug: XRP6258 (RPR116258)
  • administered by IV route
• Drug: mitoxantrone
  • administered by IV route
• Drug: prednisone
  • administered by oral route

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: Arm A
• Experimental: Arm B

Primary Measures

• overall survival defined as the time interval from the date of randomization to the date of death due to any cause.
  • Time Frame: study period
    Safety Issue?: No

Secondary Measures

• PSA levels
  • Time Frame: at screening, day 1 of every treatment cycle, end of study treatment, and in follow-up until documented progression
    Safety Issue?: No
• Anti-tumor activity via Computerized Tomography / Magnetic Resonance Imaging (and bone scans, as indicated)
  • Time Frame: study period
    Safety Issue?: No
• Pain via an analgesic consumption score and the Present Pain Index over a one-week period
  • Time Frame: study period
    Safety Issue?: No
• Adverse events; laboratory abnormalities; vital signs
  • Time Frame: Study period
    Safety Issue?: Yes

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.

Gender Eligibility for this Clinical Trial: Male

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Sanofi-Aventis

Overall Clinical Trial Officials and Contacts

ICD Study Director Sanofi-Aventis  

Information obtained from ClinicalTrials.gov on July 02, 2009

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