Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Linifanib · 2 trials · 1 indication
Blood samples for the pharmacokinetics (PK) of linifanib will be collected at designated time points and assayed.
To assess the effect of rifampin on the pharmacokinetics of linifanib and metabolite(s), an analysis will be performed for the natural logarithms of Cmax and AUC of linifanib and metabolite(s) with concentrations that permit confident determination of values of the pharmacokinetic variables. A paired t-test will be performed to compare the central value on Study Day 13 (with rifampin) to that on Study Day 1 (without rifampin). Point estimates and 90% confidence intervals will also be provided.
| Arm | Type | Description |
|---|---|---|
| linifanib | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| linifanib | DRUG | QD on Day 1 of Periods 1 and 2 |
| Rifampin | DRUG | QD on Days 5-16 |
Inclusion Criteria 1. Age is greater than or equal to 18 years. 2. Subject must have a histologically or cytologically confirmed non-hematologic malignancy other than Hepatocellular Carcinoma (HCC). 3. Eastern Cooperative Oncology Group (ECOG) Performance Score of 0-2. 4. Subject must have adequate...
| 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 |
Linifanib is an investigational small molecule being developed for the treatment of advanced solid tumors. It is currently in Phase 1 clinical development, meaning it has not yet been approved by regulatory authorities and is still being studied for safety and efficacy in clinical trials.
Linifanib is being developed by Abbott Laboratories, a company traded on the stock exchange under the ticker symbol ABT. The drug is in Phase 1 clinical development for advanced solid tumors.
Linifanib is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still being studied in clinical trials for safety and efficacy in patients with advanced solid tumors.
Linifanib has been studied in two completed Phase 1 clinical trials. One trial, NCT01381341, compared the relative bioavailability of two clinical formulations of Linifanib in 13 patients with advanced solid tumors. The other trial, NCT01401933, studied the effect of rifampin on the pharmacokinetics of Linifanib in 14 patients with advanced or metastatic solid tumors.
Linifanib is not FDA approved. It is an investigational drug currently in Phase 1 clinical development for advanced solid tumors. The drug has been studied in two completed clinical trials, but it has not yet received regulatory approval.