Clinical trial · Interventional
ET 743 (Yondelis) in Men With Advanced Prostate Cancer
A Phase II Study of Three Hour, Weekly Infusion of ET 743 (Yondelis) in Men With Advanced Prostate Cancer
NCT00147212CI-TRIAL-00008990completedPhase 2Results postedClinicalTrials.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 main purpose of this study is to find out what effects (good or bad) trabectedin (ET743) has on men with advanced prostate carcinoma.
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 |
|---|---|---|---|
| ET 743 | Drug | Trabectedin | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 1
- description
- ET-743
- interventionNames
- Drug: ET 743
Primary outcomes (1)
- measure
- The Number of Men With Advanced Prostate Cancer Treated With Trabectedin Who Have a PSA Response
- timeFrame
- Participants were followed until disease progression, an average of 6 months
- description
- Prostate specific antigen (PSA) response rate, as defined by the PSA Working Group Criteria (see Bubley et al, J Clin Oncol. 1999 Nov;17(11):3461-7)
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 (PSA) \> 5 ng/ml * Castration resistant prostate cancer (CRPC) * One previous taxane-based chemotherapy regimen * Eastern Cooperative Group (ECOG) performance status 0,1 or 2 * Neutrophil count \> 1,500/ul * Platelet count \> 100,000/ul * Serum bilirubin \< 1.0 x upper limit normal (ULN) * Serum alkaline phosphatase \< 1.5 x ULN * Asparate aminotransferase/Alanine aminotransferase \< 2.5 x ULN * Albumin \> 2.5 g/dl * Serum creatinine \< 1.5 x ULN * Prior hormonal therapy Exclusion Criteria: * Chemotherapy treatment within 4 weeks of study entry * Patient not employing adequate contraception * Serious illness or medical conditions, specifically: uncontrolled congestive heart failure or history of myocardial infection or active angina pectoris within 6 months; active infectious process; chronic active liver disease, including chronic hepatitis B, C or cirrhosis * Current anti-cancer treatment with any non-FDA approved investigational drug
References
Publications (0)
Data not yet available
No reference posted for this study.