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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00060944 | A Study to Assess Treatment With 2 Different Dosing Schedules of Trabectidin Administered to Patients With Advanced Cancer | PHASE2 | COMPLETED | 271 | — | — | May 1, 2003 | May 1, 2008 | Sep 8, 2014 | 39 | United States, Australia +6 |
Time to Progression was defined as time between randomization and the first documentation of disease progression or death due to progressive disease.
| Arm | Type | Description |
|---|---|---|
| Yondelis weekly schedule | EXPERIMENTAL | Yondelis weekly schedule: 0.58 mg/m2 administered as a 3-hour i.v. infusion on Days 1 8 and 15 of each 28-day treatment cycle. Patients will be pretreated with 10 mg of dexamethasone i.v. 30 minutes prior to each infusion. |
| Yondelis once every 3 weeks schedule | EXPERIMENTAL | Yondelis once every 3 weeks schedule: 1.5 mg/m2 administered as a 24-hour i.v. infusion on Day 1 of every 21-day treatment cycle. Patients will be pretreated with 20 mg of dexamethasone i.v. on Day 1 of each treatment cycle 30 minutes prior to each infusion. |
| Name | Type | Description |
|---|---|---|
| Yondelis | DRUG | 1.5 mg/m2 administered as a 24-hour i.v. infusion on Day 1 of every 21-day treatment cycle. |
| Dexamethasone | DRUG | Pretreatment with 10 mg of dexamethasone i.v. 30 minutes prior to each Yondelis infusion on Days 1, 8, and 15 of each 28-day treatment cycle. |
Inclusion Criteria: * Have advanced liposarcoma or leiomyosarcoma that has metastasized (spread) * Have a pathology specimen available for centralized review * Have progressive or relapsed (reappearance of) disease, received treatment with anthracycline and/or ifosfamide before enrollment in study,...