A Phase 2 Study of Trabectedin (Yondelis) in Adult Male Participants With Advanced Prostate Cancer

• Status: Completed
• Trial end date: 2008-11-01
• Target enrollment: 0
• Participant gender: Male

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) prostate cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Collaborator: PharmaMar
• Treatments: Trabectedin

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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