Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ARQ 197 · 9 trials · 12 indications
| Arm | Type | Description |
|---|---|---|
| ARQ 197 | EXPERIMENTAL | - |
| placebo | PLACEBO_COMPARATOR | - |
| 1 | EXPERIMENTAL | Erlotinib (150 mg) once daily plus ARQ 197 (360 mg) twice daily. |
| 2 | ACTIVE_COMPARATOR | Erlotinib (150 mg) once daily plus ARQ 197 placebo twice daily |
| 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. |
| Erlotinib | DRUG | Erlotinib is a white, film coated tablet in strengths of 25, 100 and 150 mg administered once daily until disease progression, unacceptable toxicity or other discontinuation criterion is met. |
| gemcitabine | DRUG | 1000 mg/m2 administered as an intravenous infusion over 30 minutes once weekly for 4 weeks for the first 28 days (cycle). Each subsequent cycle will consist of 1000 mg/m2 administered as an intravenous infusion over 30 minutes once weekly for 3 weeks with no drug administered in the 4th week. |
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 ...
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ARQ 197 is an investigational small molecule being studied for use in oncology. It has been evaluated in clinical trials for conditions including cirrhosis, pancreatic neoplasms, cancer, advanced solid tumors, non-small cell lung cancer, and metastatic non-small cell lung cancer. ARQ 197 is not approved and remains in clinical development.
ARQ 197 is being developed by Merck & Company, Inc., which trades under the ticker MRK. The drug is an investigational small molecule in the oncology therapeutic area. As of the latest data, ARQ 197 has completed Phase 1 clinical trials but is not yet approved.
ARQ 197 is in Phase 1 clinical development. All four clinical trials listed for ARQ 197 are Phase 1 studies and have been completed. The drug is investigational and has not received FDA approval. No active trials are currently listed for ARQ 197.
ARQ 197 has been studied in four completed Phase 1 clinical trials. These include NCT00302172 in metastatic solid tumors, NCT00612209 and NCT00612703 in advanced solid tumors, and NCT00658554, a bioequivalence study in healthy volunteers. Total enrollment across these trials was 167 participants.
ARQ 197 is also known as tivantinib. The drug has been studied under the name ARQ 197 in clinical trials for various cancers, including advanced solid tumors and non-small cell lung cancer. It is an investigational small molecule developed by Merck & Company, Inc.