Status:
COMPLETED
XRP6258 Plus Prednisone Compared to Mitoxantrone Plus Prednisone in Hormone Refractory Metastatic Prostate Cancer
Lead Sponsor:
Sanofi
Conditions:
Neoplasms
Prostatic Neoplasms
Eligibility:
MALE
18+ years
Phase:
PHASE3
Brief Summary
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 pros...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Histologically or cytologically confirmed adenocarcinoma of the prostate that is refractory to hormone therapy and previously treated with a Taxotere®-containing regimen.
- 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 prostate-specific antigen (PSA) levels or appearance of new lesion.
- Surgical or hormone-induced castration
- Life expectancy \> 2 months
- Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2
- Exclusion criteria
- Previous treatment with mitoxantrone
- Previous treatment with \<225 mg/m\^2 cumulative dose of Taxotere (or docetaxel)
- Prior radiotherapy to ≥ 40% of bone marrow
- Surgery, radiation, chemotherapy, or other anti-cancer therapy within 4 weeks prior to enrollment in the study
- 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
- Known brain or leptomeningeal involvement
- Other concurrent serious illness or medical conditions
- Inadequate organ function evidenced by unacceptable laboratory results
- The investigator will evaluate whether there are other reasons why a patient may not participate.
Exclusion
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2009
Estimated Enrollment :
755 Patients enrolled
Trial Details
Trial ID
NCT00417079
Start Date
January 1 2007
End Date
September 1 2009
Last Update
March 10 2011
Active Locations (26)
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1
sanofi-aventis US
Bridgewater, New Jersey, United States, 08807
2
sanofi-aventis Argentina
Buenos Aires, Argentina
3
sanofi-aventis Belgium
Diegem, Belgium
4
sanofi-aventis Brazil
São Paulo, Brazil