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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02234986 | A Multi-center, Open-label Study of Oral ENMD-2076 for the Treatment of Patients With Advanced Fibrolamellar Carcinoma | PHASE2 | COMPLETED | 35 | — | — | Oct 1, 2015 | Jun 30, 2018 | Apr 18, 2025 | 5 | United States |
6-month overall response rate (ORR rate) using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR) - disappearance of all target lesions; partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; ORR = proportion of patients evaluated as CR + PR
| Arm | Type | Description |
|---|---|---|
| ENMD-2076 | EXPERIMENTAL | ENMD-2076, oral capsule Once daily dose 250 mg/day |
| Name | Type | Description |
|---|---|---|
| ENMD-2076 | DRUG | 250 mg oral dose, once daily (QD) for 28 day cycles |
Inclusion Criteria: * Histologically or cytologically confirmed advanced fibrolamellar carcinoma (FLC). * All forms of prior local therapy are allowed as long as patients have either a target lesion, which has not been treated with local therapy and/or the target lesion(s) within the field of the l...