Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ARQ 197 plus erlotinib · 1 trial · 1 indication
Progression is defined using Response Evaluation Criteria in Solid Tumors (RECIST v 1.1) criteria as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions or progression of existing non-target lesions are also considered progression.
| Arm | Type | Description |
|---|---|---|
| tivantinib (ARQ 197) plus erlotinib arm | EXPERIMENTAL | Eligible subjects will be randomly assigned to receive erlotinib plus tivantinib (ARQ 197). Treatment will be open-label and continue until progression of disease, unacceptable toxicity, or another discontinuation criterion is met. |
| Chemotherapy arm | ACTIVE_COMPARATOR | Investigator's choice of single agent chemotherapy (pemetrexed, docetaxel, or gemcitabine) administered in 3-week cycles according to the approved label until disease progression or unacceptable toxicity. Subjects who discontinued chemotherapy can be switched to the crossover arm (tivantinib plus erlotinib) and continue treatment until disease progression or unacceptable toxicity. |
| Name | Type | Description |
|---|---|---|
| ARQ 197 plus erlotinib | DRUG | Eligible subjects will be randomly assigned to receive erlotinib plus ARQ 197. |
| Pemetrexed, docetaxel or gemcitabine | DRUG | Investigator's choice of a single agent chemotherapy (pemetrexed, docetaxel, or gemcitabine) administered according to the approved label. |
Inclusion Criteria: 1. Provide signed and dated informed consent prior to study-specific screening procedures 2. Male or female at least 18 years of age 3. Histologically or cytologically confirmed inoperable locally advanced or metastatic (stage IVA/IVB) NSCLC 4. Documented KRAS mutation positive ...
Top 20 of 84 competitors
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.