Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as ARQ197
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 studied in oncology for advanced solid tumors and hepatocellular carcinoma. It has been evaluated in patients with inoperable hepatocellular carcinoma who received one prior therapy, and in an extension protocol for subjects previously enrolled in other Tivantinib protocols. It is not described as approved for any indication.
Tivantinib targets MET, a receptor tyrosine kinase. It is classified as a MET inhibitor. By binding to and inhibiting MET, Tivantinib is designed to interfere with MET-mediated signaling in tumor cells. This mechanism underlies its investigation in advanced solid tumors and hepatocellular carcinoma.
Tivantinib is being developed by Merck & Company, Inc., which trades under the ticker MRK. The company is the sponsor associated with the clinical development of Tivantinib in oncology, including studies in advanced solid tumors and hepatocellular carcinoma.
Tivantinib is in Phase 1 development according to the current development stage. It is an investigational agent and has not been approved by the FDA. Clinical evaluation has included a completed Phase 3 trial in hepatocellular carcinoma and a completed Phase 1 extension protocol in advanced solid tumors.
Tivantinib has been studied in two completed trials. NCT01755767 was a Phase 3 study in subjects with inoperable hepatocellular carcinoma who had one prior therapy, enrolling 383 patients across multiple countries. NCT01178411 was a Phase 1 extension protocol for subjects previously enrolled in other Tivantinib protocols, enrolling 60 patients with advanced solid tumors.