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

NCT ID: NCT00072670

Last Updated: 2014-04-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 59 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-01-31
• Study Completion Date: 2008-11-30

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) prostate cancer.

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 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.

Conditions

Prostate Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

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.

Group Type: EXPERIMENTAL

Trabectedin

Intervention Type: DRUG

Trabectedin will be administered intravenously as either 0.58 milligram per square meter (mg/m\^2) weekly as 3-hour infusion or 1.5 mg/m\^2 or 1.2 mg/m\^2 every three weeks as 24-hour infusion until disease progression or unacceptable toxicity.

Trabectedin 1.5 mg/m^2

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.

Group Type: EXPERIMENTAL

Trabectedin

Intervention Type: DRUG

Trabectedin will be administered intravenously as either 0.58 milligram per square meter (mg/m\^2) weekly as 3-hour infusion or 1.5 mg/m\^2 or 1.2 mg/m\^2 every three weeks as 24-hour infusion until disease progression or unacceptable toxicity.

Trabectedin 1.2 mg/m^2

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.

Group Type: EXPERIMENTAL

Trabectedin

Intervention Type: DRUG

Trabectedin will be administered intravenously as either 0.58 milligram per square meter (mg/m\^2) weekly as 3-hour infusion or 1.5 mg/m\^2 or 1.2 mg/m\^2 every three weeks as 24-hour infusion until disease progression or unacceptable toxicity.

Interventions

Trabectedin

Trabectedin will be administered intravenously as either 0.58 milligram per square meter (mg/m\^2) weekly as 3-hour infusion or 1.5 mg/m\^2 or 1.2 mg/m\^2 every three weeks as 24-hour infusion until disease progression or unacceptable toxicity.

Intervention Type: DRUG

Other Intervention Names

ET-743; Yondelis

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

PharmaMar

INDUSTRY

Sponsor Role: collaborator

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

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

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

Role: STUDY_DIRECTOR

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

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Countries

United States

Related Links

http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_JNJ_6051&studyid=4518&filename=CR101850_CSR.pdf

Phase 2 Study of Yondelis in Men With Advanced Prostate Carcinoma

Other Identifiers

ET-B-025-02

Identifier Type: -

Identifier Source: secondary_id

CR101850

Identifier Type: -

Identifier Source: org_study_id