Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01846611 | A Study Comparing the Combination of Trabectedin (YONDELIS) and DOXIL/CAELYX With DOXIL/CAELYX for the Treatment of Advanced-Relapsed Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer | PHASE3 | COMPLETED | 581 | — | — | Oct 16, 2013 | Nov 16, 2018 | Apr 1, 2019 | 138 | United States, Australia +8 |
| NCT00050414 | A Study of Trabectedin in Patients With Advanced Ovarian Cancer | PHASE2 | COMPLETED | 147 | — | — | Oct 1, 2002 | Sep 1, 2005 | Jan 10, 2013 | - | — |
OS is defined as the time between the date of randomization and the date of death. Participants who died, regardless of the cause of death, were considered to have had an event.
| Arm | Type | Description |
|---|---|---|
| Arm A: trabectedin + DOXIL | EXPERIMENTAL | Participants will receive DOXIL 30 millgram per meter square (mg/m\^2) administered as an intravenous (IV) infusion over approximately 90 minutes followed by trabectedin 1.1 mg/m\^2 administered as an IV infusion over approximately 3hours, every 3 weeks. Participants will be pretreated with 20 mg dexamethasone IV (or the IV equivalent) approximately 30 minutes before DOXIL study drug. As of Amendment 6, treatment with trabectedin will be discontinued for participants on treatment with trabectedin and no new participants will receive trabectedin. Participants who, in the opinion of the investigator, are deriving clinical benefit may continue treatment with single-agent DOXIL as per the local standard of care. |
| Arm B: DOXIL | ACTIVE_COMPARATOR | Participants will receive DOXIL, 50 mg/m\^2 administered as an IV infusion over approximately 90 minutes every 4 weeks. |
| Trabectedin | EXPERIMENTAL | Trabectedin 0.58 mg/m2 administered as a 3-hour intravenous infusion, Days 1, 8, and 15 every 28 days for up to approximately 3 years in the absence of disease progression. Dexamethasone 10 mg administered intravenously 30 minutes prior to each trabectedin infusion. |
| Name | Type | Description |
|---|---|---|
| Trabectedin | DRUG | 1.1 mg/m\^2 administered intravenously over approximately 3 hours on Day 1 of each 21-day treatment cycle. |
| DOXIL | DRUG | 30 mg/m\^2 administered intravenously over approximately 90 minutes on Day 1 of each 21-day treatment cycle. |
| Dexamethasone | DRUG | 20 mg administered intravenously on Day 1 of each 21-day treatment cycle approximately 30 minutes prior to study drug infusion. |
Inclusion Criteria: * Histologically proven advanced-relapsed epithelial ovarian, primary peritoneal, or fallopian tube cancer * Eastern Cooperative Oncology Group (ECOG) performance status grade of 0 or 1 * Received first-line treatment with a platinum-based regimen and had no evidence of disease ...