Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Tivantinib · 2 trials · 2 indications
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.
The duration of ARQ 197 exposure in this study was calculated as \[(date of last dose of study drug - date of first dose of study drug) + 1\]. Results refer to duration of ARQ 197 treatment in the present study only (i.e., does not include treatment received during participation in "feeder" studies).
| 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. |
| Tivantinib (Monotherapy or Combination Therapy) | EXPERIMENTAL | Tivantinib 360 mg will be administered twice daily, orally, with meals, as a monotherapy or in combination with other drug therapies. |
| Name | Type | Description |
|---|---|---|
| Tivantinib | DRUG | Tivantinib tablets |
| Placebo | DRUG | Matching placebo tablets |
| Anti-Cancer Combination Therapy | DRUG | Tivantinib 360 mg twice daily in combination with other anti-cancer therapy (eg, erlotinib,sorafenib, pemetrexed, docataxel, gemcitabine, irinotecan, and/or cetuximab) at the same dose and schedule in which they were administered in the original (previous) study. |
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...
Tivantinib is an investigational small molecule being studied for the treatment of hepatocellular carcinoma and advanced solid tumors. It is an oral oncology drug in clinical development, though it is not approved by the FDA and remains investigational.
Tivantinib is being developed by Merck & Company, Inc., which trades under the ticker symbol MRK. The company is conducting clinical trials to evaluate the drug's safety and efficacy in cancer patients.
Tivantinib has been studied in Phase 1 and Phase 3 clinical trials. A Phase 1 extension study for advanced solid tumors has been completed, and a Phase 3 study in hepatocellular carcinoma has also been completed. The drug is investigational and not FDA approved.
Tivantinib has been evaluated in two completed trials: NCT01178411, a Phase 1 extension study for advanced solid tumors with 60 participants, and NCT01755767, a Phase 3 study in inoperable hepatocellular carcinoma with 383 participants. Both trials are completed.
Tivantinib is not biomarker-selected in its clinical trials. The studies did not require patients to have a specific biomarker, and the trials were uncontrolled, meaning there was no comparator arm.