Clinical trial · Interventional
A Phase 2 Study of Trabectedin (Yondelis) in Adult Male Participants With Advanced Prostate Cancer
Phase 2 Study of Yondelis in Men With Advanced Prostate Carcinoma
NCT00072670CI-TRIAL-00014206completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Trabectedin | Drug | Trabectedin | ALIAS |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Trabectedin 0.58 milligram per square meter (mg/m^2)
- 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.
- interventionNames
- Drug: Trabectedin
- type
- EXPERIMENTAL
- label
- Trabectedin 1.5 mg/m^2
- 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.
- interventionNames
- Drug: Trabectedin
- type
- EXPERIMENTAL
- label
- Trabectedin 1.2 mg/m^2
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.