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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02024087 | Study of Dalantercept and Sorafenib in Patients With Advanced Hepatocellular Carcinoma | PHASE1 | COMPLETED | 21 | — | — | Aug 4, 2014 | Sep 22, 2017 | Sep 26, 2022 | 7 | United States |
Assessed by monitoring AEs using the current active minor version on the National Cancer Institute Common Toxicity Criteria for Adverse Events, version 4.0 (NCI-CTCAE v4 current minor version), physical examinations, vital signs, clinical laboratory test, ECHO, ECG and ADA testing; through final study visit, up to approximately 20 weeks from first dose of dalantercept.
| Arm | Type | Description |
|---|---|---|
| Dalantercept 0.6 mg/kg plus sorafenib 400 mg | EXPERIMENTAL | Cohort 1: Participants received dalantercept 0.6 mg/kg by subcutaneous (SC) injection once every 3 weeks plus sorafenib 400 mg orally (PO) once daily |
| Dalantercept 0.4 mg/kg plus sorafenib 400 mg | EXPERIMENTAL | Cohort 2: Participants will receive dalantercept 0.4 mg/kg SC injection once every 3 weeks plus sorafenib 400 mg PO once daily |
| Expansion cohort - dalantercept 0.4 mg/kg plus sorafenib 400 mg | EXPERIMENTAL | Cohort 3: Participants will receive dalantercept 0.4 mg/kg SC injection once every 3 weeks plus sorafenib 400 mg PO once daily |
| Name | Type | Description |
|---|---|---|
| Dalantercept plus sorafenib | DRUG | Subcutaneous (SC) injection of dalantercept once every 3 weeks and oral sorafenib daily. |
Inclusion Criteria: * Histologically confirmed, locally advanced or metastatic HCC. * Child-Pugh Score A (5-6) * At least one target lesion that has not been treated with local therapy and is measurable by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 * Eastern Cooperative Oncology Gro...