Status:
COMPLETED
A Phase 2 Study of Trabectedin (Yondelis) in Adult Male Participants With Advanced Prostate Cancer
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Collaborating Sponsors:
PharmaMar
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate safety and efficacy of trabectedin (ET-743) in adult male participants with advanced metastatic (spread of cancer cells from one part of the body to another) p...
Detailed Description
This is an open-label (all people know the identity of the intervention), non-randomized, multi-center and Phase 2 study in adult male participants with advanced metastatic prostate cancer. The study ...
Eligibility Criteria
Inclusion
- Histologically confirmed adenocarcinoma of the prostate
- Radiographically documented metastatic disease
- Surgical or chemical castration
- Prostate-specific antigen greater than or equal to (\>=) 5 nanogram per milliliter (ng/ml)
- Eastern Cooperative Oncology Group performance status of 0, 1, or 2
- Androgen Independent disease
Exclusion
- Treatment with chemotherapy or radiation therapy that was terminated at least 4 weeks before study entry
- Treatment with extensive external beam radiation therapy or radionuclide therapy within 6 weeks of study entry (palliative radiation involving less than 20 percent of bone marrow reserves must have been completed at least 4 weeks before study entry)
- Participant not employing adequate contraception
- Other serious illness or medical conditions as : Uncontrolled congestive heart failure or history of myocardial infection or active angina pectoris within six months preceding registration; active infectious process; chronic active liver disease, including chronic Hepatitis B, chronic Hepatitis C, or cirrhosis
Key Trial Info
Start Date :
January 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2008
Estimated Enrollment :
59 Patients enrolled
Trial Details
Trial ID
NCT00072670
Start Date
January 1 2004
End Date
November 1 2008
Last Update
April 8 2014
Active Locations (1)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114-2617