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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02014337 | Mifepristone and Eribulin in Patients With Metastatic Triple Negative Breast Cancer or Other Specified Solid Tumors | PHASE1 | COMPLETED | 37 | — | — | Jan 1, 2014 | Dec 1, 2017 | Jan 17, 2018 | 11 | United States |
In the dose escalation phase: MTD time frame is within 28 days of first dose (Cycle 1)
| Arm | Type | Description |
|---|---|---|
| Mifepristone and Eribulin in combination | EXPERIMENTAL | Single Arm |
| Name | Type | Description |
|---|---|---|
| Mifepristone and Eribulin in combination | DRUG | Single Arm, Two Parts Part 1: Dose Escalation Phase to determine MTD and RP2D in up to 20 patients Part 2: Dose Expansion Phase at RP2D in 20 patients |
Inclusion Criteria: 1. Informed consent given prior to study-specific screening procedures 2. ≥ 18 years old Part 2, dose expansion: 1. Diagnosis of TNBC: \< 1% cells positive for ER/progesterone receptor, and HER2 IHC score of 0 or 1, or FISH HER2+ ratio of less than 1.8; patients with low ER IH...