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

Johnson & Johnson (J&J)

Status and phase: Completed; Phase 2

Conditions: Prostate Cancer

Treatments: Drug: Trabectedin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00072670

CR101850

ET-B-025-02

Details and patient eligibility

About

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.

Full 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 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.

Enrollment: 59 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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59 participants in 3 patient groups

Trabectedin 0.58 milligram per square meter (mg/m^2)

Experimental group

Description:

Trabectedin will be administered as 3-hour intravenous infusion at dose of 0.58 mg/m\^2 weekly on Day 1, 8 and 15 in 28-day cycle and will be continued until disease progression or unacceptable toxicity.

Treatment:

Drug: Trabectedin

Trabectedin 1.5 mg/m^2

Experimental group

Description:

Trabectedin will be administered at dose of 1.5 mg/m\^2 as 24-hour infusion every three weeks, and will be continued until disease progression or unacceptable toxicity.

Treatment:

Drug: Trabectedin

Trabectedin 1.2 mg/m^2

Experimental group

Description:

Trabectedin will be administered at dose of 1.2 mg/m\^2 as 24-hour infusion every three weeks, and will be continued until disease progression or unacceptable toxicity.

Treatment:

Drug: Trabectedin