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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01755767 | Study of Tivantinib in Subjects With Inoperable Hepatocellular Carcinoma (HCC) Who Have Been Treated With One Prior Therapy | PHASE3 | COMPLETED | 383 | — | — | Dec 27, 2012 | Jul 31, 2017 | Apr 6, 2021 | 112 | United States, Argentina +14 |
Overall survival (OS) is defined as the time from randomization to the date of death. The rate of OS (percentage of participants still alive) was determined only in the tivantinib 120 mg BID cohort.
Overall survival (OS) is defined as the time from randomization to the date of death. The rate of OS (percentage of participants still alive) was determined only in the tivantinib 120 mg BID cohort.
| Arm | Type | Description |
|---|---|---|
| Tivantinib 240 mg BID Cohort | EXPERIMENTAL | The tivantinib dosage of 240 mg tablets administered by mouth twice daily (BID), once in the morning and once in the evening, with food, for a total daily dose of 480 mg. |
| Tivantinib 120 mg BID Cohort | EXPERIMENTAL | Tivantinib 120 mg is administered by oral tablet BID, once in the morning and once in the evening, with food, for a total daily dose of 240 mg (amended dosing group; primary analysis group). |
| Placebo Matching 240 mg BID Cohort | PLACEBO_COMPARATOR | Matching placebo is administered by oral tablet(s) BID, once in the morning and once in the evening, with food. |
| Placebo Matching 120 mg BID Cohort | PLACEBO_COMPARATOR | Matching placebo is administered by oral tablet(s) BID, once in the morning and once in the evening, with food. |
| Name | Type | Description |
|---|---|---|
| Tivantinib | DRUG | Tivantinib tablets |
| Placebo | DRUG | Matching placebo tablets |
Inclusion Criteria: * Histologically confirmed HCC that is inoperable (where surgery is not indicated due to disease extension, co-morbidities, or other technical reasons), and not eligible for local therapy * MET Diagnostic-High tissue reported by the central authorized laboratory using archival o...