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

Completed · Phase 2

Conditions studied: Prostate Cancer

In brief

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.

Key facts

Study ID

NCT00072670

Run by

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

People needed

59

Starts

2004-01-01

Expected to finish

2008-11-01

Last updated by the study team

2014-04-08

Who can join

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

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Massachusetts General Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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