Phase 3
Completed N=672
An Efficacy and Safety Study for Yondelis (Trabectedin) in Patients With Advanced Relapsed Ovarian Cancer
Source: ClinicalTrials.gov NCT00113607 ↗Enrolled (actual)
672
Serious AEs
35.4%
Results posted
Aug 2013
Primary outcomePrimary: Progression-Free Survival (PFS): Independent Radiologist Review — 5.8; 7.3 Months — p=0.0190
Summary
The purpose of the study is to compare the progression-free survival (PFS) of the combination of trabectedin + DOXIL with DOXIL monotherapy in patients with ovarian cancer.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression-Free Survival (PFS): Independent Radiologist Review |
5.8; 7.3 | 0.0190 sig |
| SECONDARY Overall Survival |
18.9; 22.2 | 0.0835 |
| SECONDARY Objective Response Rate (ORR) - Independent Radiologist Review |
18.8; 27.6 | 0.0080 sig |
| SECONDARY Duration of Response: Independent Radiologist Review |
7.7; 7.9 | 0.8203 |
| SECONDARY Median Area Under Curve (AUC) of Trabectedin. |
74.24 | — |
| SECONDARY Median Maximum Plasma Concentration (Cmax) of Trabectedin. |
13394 | — |
Eligibility Criteria
Inclusion Criteria
- Histologically proven epithelial ovarian cancer, epithelial fallopian tube cancer, or primary peritoneal cancer
- Prior treatment with only 1 platinum based chemotherapy regimen
- Eastern Cooperative Oncology Group status of not more than 2
- Progression more than 6 months after the start of initial chemotherapy treatment
Exclusion Criteria
- Treatment with more than 1 prior chemotherapy regimen
- Progression within 6 months after starting initial chemotherapy
- Prior exposure to anthracyclines
- Unwilling or unable to have central venous catheter
- Known clinically relevant central nervous system metastasis
Data sourced from ClinicalTrials.gov (NCT00113607). 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.