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

Information source: Sanofi
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Neoplasms; Prostatic Neoplasms

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

Phase: Phase 3

Status: Completed

Sponsored by: Sanofi

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

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 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.

Clinical Details

Official title: A Randomized, Open Label Multi-Center Study of XRP6258 at 25 mg/m^2 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: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Overall Survival

Secondary outcome:

Time to Progression Free Survival (PFS)

Overall Tumor Response

Time to Tumor Progression

Time to Prostatic Specific Antigen (PSA) Progression

PSA (Prostate-Specific Antigen) Response

Time to Pain Progression

Pain Response

Eligibility

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

Criteria:

Inclusion Criteria 1. Histologically or cytologically confirmed adenocarcinoma of the prostate that is refractory to hormone therapy and previously treated with a Taxotere®-containing regimen. 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 prostate-specific antigen (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. Previous treatment with <225 mg/m^2 cumulative dose of Taxotere (or docetaxel) 3. Prior radiotherapy to ≥ 40% of bone marrow 4. Surgery, radiation, chemotherapy, or other anti-cancer therapy within 4 weeks prior to enrollment in the study 5. 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 6. Known brain or leptomeningeal involvement 7. Other concurrent serious illness or medical conditions 8. Inadequate organ function evidenced by unacceptable laboratory results The investigator will evaluate whether there are other reasons why a patient may not participate.

Locations and Contacts

sanofi-aventis Argentina, Buenos Aires, Argentina

sanofi-aventis Belgium, Diegem, Belgium

sanofi-aventis Brazil, Sao Paulo, Brazil

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 US, Bridgewater, New Jersey 08807, United States

sanofi-aventis Canada, Laval, Quebec, Canada

sanofi-aventis UK, Guildford, Surrey, United Kingdom

Additional Information

Starting date: January 2007
Last updated: March 4, 2011

Page last updated: August 23, 2015

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