Completed

Phase 2 Study of Yondelis in Men With Advanced Prostate Carcinoma

What is being tested

Trabectedin

Drug

Who is being recruted

Urogenital Diseases+7

+ Genital Diseases

+ Genital Diseases, Male

Over 18 Years

+10 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 2

Interventional

Study Start: January 2004

See protocol details

Summary

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

Last updated: January 27, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: January 1, 2004

Actual date on which the first participant was enrolled.

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.

Official TitlePhase 2 Study of Yondelis in Men With Advanced Prostate Carcinoma

NCT00072670

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

Last updated: January 27, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

59 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Male

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesGenital DiseasesGenital Diseases, MaleGenital Neoplasms, MaleNeoplasmsNeoplasms by SiteProstatic DiseasesProstatic NeoplasmsUrogenital NeoplasmsMale Urogenital Diseases

Criteria

6 inclusion criteria required to participate

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)

Show More Criteria

4 exclusion criteria prevent from participating

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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

3 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

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.

Group II

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.

Group III

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.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Massachusetts General Hospital

Boston, United StatesOpen Massachusetts General Hospital in Google Maps

CompletedOne Study Center