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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00050427 | A Study of ET-743 (Trabectedin) in Patients With Advanced Breast Cancer | PHASE2 | COMPLETED | 53 | — | — | Dec 1, 2002 | Dec 1, 2006 | Apr 28, 2011 | - | — |
| Arm | Type | Description |
|---|---|---|
| 001 | EXPERIMENTAL | ET743 580 mcg/m2 3-hour i.v. infusion on Days 1 8 and 15 every 28 days for up to approximately 52 weeks in the absence of disease progression. Dexamethasone 10 mg i.v will be administered 30 minutes prior to each trabectedin infusion. |
| 002 | EXPERIMENTAL | ET743 1 300 mcg/m2 3 hour i.v. infusion once every 21 days for up to approximately 52 weeks in the absence of disease progression. Dexamethasone 10 mg i.v will be administered 30 minutes prior to each trabectedin infusion. |
| Name | Type | Description |
|---|---|---|
| ET743 | DRUG | 580 mcg/m2, 3-hour i.v. infusion, on Days 1, 8, and 15 every 28 days for up to approximately 52 weeks in the absence of disease progression. Dexamethasone, 10 mg i.v, will be administered 30 minutes prior to each trabectedin infusion. |
Inclusion Criteria: * Diagnosis of advanced breast cancer * Prior therapy with anthracycline and taxane (2 types of chemotherapy drugs) * At least one measureable tumor lesion * Adequate bone marrow, hepatic and renal function * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1...