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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00988741 | Trial of ARQ 197 in Patients With Unresectable Hepatocellular Carcinoma (HCC) Who Have Failed One Prior Systemic Therapy | PHASE2 | COMPLETED | 107 | — | — | Sep 1, 2009 | Mar 1, 2012 | Feb 28, 2013 | 23 | United States, Belgium +3 |
| Arm | Type | Description |
|---|---|---|
| ARQ 197 | EXPERIMENTAL | - |
| placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| ARQ 197 | DRUG | The investigational drug ARQ 197 is supplied as capsules. A dose of 360 mg (3 capsules of 120 mg each) of ARQ 197 will be administered by mouth BID, once in the morning and once in the evening with meals, for a total daily dose of 720 mg. Under Amendment 2, a dose of 240 mg (2 capsules of 120 mg each) of ARQ 197/placebo will be administered by mouth BID, once in the morning and once in the evening with meals, for a total daily dose of 480 mg. A treatment cycle is defined as 4 weeks for both treatment arms. Cycles will be repeated every 4 weeks (28 days) based on toxicity and response. |
| Placebo | DRUG | The placebo is provided in a capsule form. |
Inclusion Criteria: * Written informed consent granted prior to initiation of any study-specific screening procedures * 18 year of age or older * Histologically or cytologically confirmed HCC * Archival, fresh core needle biopsy or fine needle aspiration (FNA) tumor samples * Received at least one ...