Boston,
Massachusetts
02114
Purpose:
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.
Study summary:
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 consists of 3 parts: Screening (consists of 14 days before study
commences on Day -1); Treatment (consists of 4-week dosing cycles wherein trabectedin will
be administered as intravenously at a dose of either 0.58 milligram per square meter
[mg/m^2] weekly 3-hour infusion, or 1.5 mg/m^2 or 1.2 mg/m^2 every three weeks 24-hour
infusion); and Follow-up (until survival after the first dose of trabectedin). Participants
will discontinue study treatment at disease progression or unacceptable toxicity unless, in
the Investigator's opinion, it is deemed that the participants will continue to derive
benefit from trabectedin. Efficacy will be evaluated primarily through decline in
prostate-specific antigen (substance in blood that is measured to check for prostate cancer)
after 72 hours of therapy on Day 1. Participants' safety will be monitored throughout the
study.
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
Primary Contact:
Study Director
Johnson & Johnson Pharmaceutical Research & Development, L.L.C Clinical Trial
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.