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

NCT00072670 | Completed Phase 2 DMC

• 2 other identifiers: CR101850ET-B-025-02
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Keywords

Prostate cancer; Advanced prostate cancer; Metastatic prostate cancer; Trabectedin; Yondelis; ET-743

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Achieving Prostate-Specific Antigen (PSA) Response

  The PSA response will be evaluated according to National Cancer Institute PSA Working Group criterion, which is, greater than or equal to 50 percent decrease in PSA from Baseline after the first dose of study drug, which would be subsequently confirmed by a measurement, that is, at least 4 or more weeks after initial documentation of PSA.

  Day 1 of each cycle until first documented disease progression up to 4 years

Secondary Outcomes (2)

• Duration of Prostate-Specific Antigen Response

  Day 1 of each cycle until first documented disease progression up to 4 years

• Time to disease progression

  Day 1 of each cycle until first documented disease progression up to 4 years

Study Arms (3)

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

EXPERIMENTAL

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.

Drug: Trabectedin

Trabectedin 1.5 mg/m^2

EXPERIMENTAL

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.

Drug: Trabectedin

Trabectedin 1.2 mg/m^2

EXPERIMENTAL

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.

Drug: Trabectedin

Interventions

Trabectedin 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.

Also known as: ET-743, Yondelis

Trabectedin 0.58 milligram per square meter (mg/m^2); Trabectedin 1.2 mg/m^2; Trabectedin 1.5 mg/m^2

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Johnson & Johnson Pharmaceutical Research & Development, L.L.C.: lead
• PharmaMar: collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114-2617, United States

Location

Related Links

• Phase 2 Study of Yondelis in Men With Advanced Prostate Carcinoma

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Trabectedin

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Dioxoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Tetrahydroisoquinolines; Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

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

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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2003
• First Posted: November 11, 2003
• Study Start: January 1, 2004
• Primary Completion: September 1, 2008
• Study Completion: November 1, 2008
• Last Updated: April 8, 2014

Record last verified: 2014-04

Locations

US (1)