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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02191878 | Safety, Pharmacokinetics and Preliminary Anti-Tumor Activity of Intravenous TKM-080301 in Subjects With Advanced Hepatocellular Carcinoma | PHASE1 | COMPLETED | 43 | — | — | Jun 1, 2014 | Jul 1, 2016 | Jan 16, 2019 | 15 | United States, Canada +4 |
Laboratory assessments
| Arm | Type | Description |
|---|---|---|
| Phase 1 Escalation / Phase 2 Expansion | EXPERIMENTAL | Phase 1 - dose escalation with intravenous infusion of TKM-080301 to determine MTD. Phase 2 - dose expansion at the MTD. |
| Name | Type | Description |
|---|---|---|
| TKM-080301 | DRUG | TKM-080301 intravenous infusion |
Key Inclusion Criteria: * Child-Pugh class of A * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤5.0 × ULN * Total bilirubin ≤3.0 mg/dL * Platelets ≥75,000 /mL * International Normalized Ratio (INR) ≤1.7 ...