Phase 2
Completed N=50
ET 743 (Yondelis) in Men With Advanced Prostate Cancer
Source: ClinicalTrials.gov NCT00147212 ↗Enrolled (actual)
50
Serious AEs
20.0%
Results posted
Jan 2013
Primary outcomePrimary: The Number of Men With Advanced Prostate Cancer Treated With Trabectedin Who Have a PSA Response — 7 participants
Summary
The main purpose of this study is to find out what effects (good or bad) trabectedin (ET743) has on men with advanced prostate carcinoma.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Number of Men With Advanced Prostate Cancer Treated With Trabectedin Who Have a PSA Response |
7 | — |
Eligibility Criteria
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 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
Data sourced from ClinicalTrials.gov (NCT00147212). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.