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

Completed · Phase 3

Conditions studied: Neoplasms, Prostatic Neoplasms

In brief

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.

Key facts

Study ID

NCT00417079

Run by

Sanofi

People needed

755

Starts

2007-01-01

Expected to finish

2009-09-01

Last updated by the study team

2011-03-10

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• sanofi-aventis US — Bridgewater, New Jersey, United States
• sanofi-aventis Argentina — Buenos Aires, Argentina
• sanofi-aventis Belgium — Diegem, Belgium
• sanofi-aventis Brazil — São Paulo, Brazil
• sanofi-aventis Canada — Laval, Quebec, Canada
• sanofi-aventis Chile — Santiago, Chile
• sanofi-aventis Czech Republic — Prague, Czechia
• sanofi-aventis Denmark — Hørsholm, 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 — Milan, Italy
• sanofi-aventis Mexico — México, Mexico
• sanofi-aventis Netherlands — Gouda, Netherlands
• sanofi-aventis Russia — Moscow, Russia
• sanofi-aventis Singapore — Singapore, Singapore
• sanofi-aventis Slovakia — Bratislava, Slovakia
• sanofi-aventis South Africa — Midrand, South Africa
• sanofi-aventis South Korea — Seoul, South Korea
• sanofi-aventis Spain — Barcelona, Spain
• sanofi-aventis Sweden — Bromma, Sweden
• sanofi-aventis Taiwan — Taipei, Taiwan
• sanofi-aventis Turkey — Istanbul, Turkey (Türkiye)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.