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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03377179 | A Study of ABC294640 Alone and in Combination With HCQ Sulfate in the Treatment of Advanced Cholangiocarcinoma | PHASE2 | COMPLETED | 65 | — | — | Mar 7, 2018 | Jun 21, 2022 | Jul 23, 2025 | 5 | United States |
To determine the response rate (RR) of CCA defined as objective responses (OR), i.e. complete and partial responses (CR, PR) plus stable disease (SD) of at least 4 months to treatment with ABC294640.
To determine the Durable Disease Control Rate (DDCR) of CCA defined as Disease Control Rate (DCR) of at least 4 months duration to treatment with ABC294640 and HCQ
| Arm | Type | Description |
|---|---|---|
| ABC294640 +/- HCQ treatment | EXPERIMENTAL | Part 1: All participants will be receiving ABC294640, 500 mg twice a day (BID), continuously in 28 day cycles Part 2: All participants will be receiving ABC294640, 500 mg twice a day (BID) and HCQ at a determined level, continuously in 28 day cycles |
| Name | Type | Description |
|---|---|---|
| ABC294640 | DRUG | Two 250 mg capsules of ABC294640 will be taken twice daily |
| Hydroxychloroquine Sulfate 200 MG | DRUG | HCQ tablets will be taken at a dose that will be determined |
Inclusion Criteria: 1. Patients with histologically confirmed intrahepatic, perihilar or extra-hepatic CCA. 2. Patients with no more than 2 prior treatments with systemic anti-neoplastic therapy for CCA. 3. The tumor is unresectable and not amenable to curative therapy. 4. One or more tumors measur...