Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Tivantinib · 1 trial · 1 indication
The primary endpoints are the area under the concentration time curve from time of dosing until 12 hours post-dose (AUC0-12) and maximum observed concentration in plasma (Cmax) of ARQ 197 following the administration of the tablet (fed conditions) and capsule formulation (at least 1 hour before or 2 hours after a meal).
| Arm | Type | Description |
|---|---|---|
| ARQ 197 Capsule, oral | EXPERIMENTAL | Oral BID 360 mg dose (Capsule C: 6 X 60 mg) of ARQ 197 at least 1 hour before or 2 hours after a meal for 7 days |
| ARQ 197 Tablet, oral | EXPERIMENTAL | Oral BID 360 mg dose (Tablet: 3 x 120 mg) of ARQ 197 under fed conditions for 7 days |
| ARQ 197 Capsule D, oral | EXPERIMENTAL | Oral BID 360 mg dose (Capsule D: 3 x 120 mg) of ARQ 197 under fed conditions in the extension phase |
| Name | Type | Description |
|---|---|---|
| Tivantinib (ARQ 197) Capsule | DRUG | Oral BID 360 mg dose (Capsule C: 6 X 60 mg) of ARQ 197 at least 1 hour before or 2 hours after a meal for 7 days |
| Tivantinib (ARQ 197) Tablet | DRUG | Oral BID 360 mg dose (Tablet: 3 x 120 mg) of ARQ 197 under fed conditions for 7 days |
| Tivantinib (ARQ 197) Capsule D, oral | DRUG | Oral BID 360 mg dose (Capsule D: 3 x 120 mg) of ARQ 197 under fed conditions in the extension phase |
Inclusion Criteria: * Subjects must have a histologically or cytologically confirmed advanced solid tumor at screening. * Male or female equal or greater than 18 years of age. * All female subjects of childbearing potential must each have a negative serum pregnancy test result before initiating stu...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Merck & Co., Inc. | MRK | 2 | PHASE2 | pembrolizumab |
| Incyte Corporation | INCY | 1 | PHASE2 | Chemotherapy, Retifanlimab |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | E7 TCR-T cells, Aldesleukin |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115, pembrolizumab |
| AstraZeneca PLC | AZN | 1 | - | Trastuzumab deruxtecan |
Tivantinib is an investigational small molecule being studied for the treatment of solid tumors. It is in Phase 1 clinical development for this oncology indication. The drug is being evaluated in patients with advanced solid tumors to determine its safety and pharmacokinetic profile.
Tivantinib is a small molecule that targets the c-Met receptor tyrosine kinase. By inhibiting this target, it is intended to interfere with tumor growth and progression in solid tumors. The drug is being studied in biomarker-selected patients, suggesting a focus on tumors that may be dependent on this pathway.
Tivantinib is being developed by Icon Plc, a company publicly traded under the ticker ICLR. The drug is currently in Phase 1 clinical trials for solid tumors, with one completed study involving 24 patients in the United States.
Tivantinib is in Phase 1 clinical development. It is an investigational drug, not yet approved by regulatory authorities. One Phase 1 trial has been completed, and the drug is being studied in patients with advanced solid tumors.
Tivantinib has one completed clinical trial, NCT01149720, which was a Phase 1 study titled 'Determination of the Relative Bioavailability of ARQ 197 Tablet Formulation With Capsule C Formulation as a Reference in Subjects With Advanced Solid Tumors.' The trial enrolled 24 patients with solid tumors in the United States.
Yes, Tivantinib is also known as ARQ 197. The clinical trial NCT01149720 refers to the drug as ARQ 197, confirming that these names are used interchangeably for the same investigational small molecule being developed for solid tumors.