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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00073736 | Safety and Tolerability of I.V. Infusion of MB07133 in Patients With Unresectable Hepatocellular Carcinoma | PHASE1 | COMPLETED | 28 | — | — | Sep 1, 2003 | - | Aug 12, 2011 | 4 | United States, Hong Kong +1 |
To determine the dose-limiting toxicities (DLT) of MB07133; To determine the maximum-tolerated continuous infusion dose (MTD) of MB07133
| Arm | Type | Description |
|---|---|---|
| MB07133 Dose Level 1 | EXPERIMENTAL | 7-day continuous infusion in 28-day cycles |
| MB07133 Dose Level 2 | EXPERIMENTAL | 7-day continuous infusion in 28-day cycles |
| MB07133 Dose Level 3 | EXPERIMENTAL | 7-day continuous infusion in 28-day cycles |
| MB07133 Dose Level 4 | EXPERIMENTAL | 7-day continuous infusion in 28-day cycles |
| MB07133 Dose Level 5 | EXPERIMENTAL | 7-day continuous infusion in 28-day cycles |
| Name | Type | Description |
|---|---|---|
| MB07133 300mg/m2/day | DRUG | 7-day continuous infusion in 28-day cycles |
| MB07133 600 mg/m2/day | DRUG | 7-day continuous infusion in 28-day cycles |
| MB07133 1200 mg/m2/day | DRUG | 7-day continuous infusion in 28-day cycles |
| MB07133 1800 mg/m2/day | DRUG | 7-day continuous infusion in 28-day cycles |
| MB07133 2400 mg/m2/day | DRUG | 7-day continuous infusion in 28-day cycles |
Inclusion Criteria: * Patients with a diagnosis of local unresectable HCC confirmed by histology using fine needle aspirate (FNA) or liver biopsy. "Local" is defined as disease either restricted to the liver or contiguous with the liver and no identifiable extrahepatic disease. * Patients with Chil...