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Also known as ABT-869
Linifanib · 3 trials · 2 indications
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.
Blood samples for the PK of ABT-869 and ketoconazole will be collected at designated time points throughout the study.
| Arm | Type | Description |
|---|---|---|
| linifanib | EXPERIMENTAL | - |
| Arm 1 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| linifanib | DRUG | QD on Day 1 of Periods 1 and 2 |
| Rifampin | DRUG | QD on Days 5-16 |
| ABT-869 | DRUG | 2.5mg \[5 mg days 1, 8 and 12. 17.5 mg on days 13 and after\] |
| ketoconazole | DRUG | 400 mg days 6-11 |
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 | 3 | PHASE2 | Pembrolizumab, Gardasil 9 |
| Incyte Corporation | INCY | 1 | PHASE2 | Retifanlimab |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115 |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | Aldesleukin |
| AstraZeneca PLC | AZN | 1 | - | Trastuzumab deruxtecan |
Linifanib is an investigational small molecule being studied in adults with advanced solid tumors. It has been evaluated in Phase 1 clinical trials, including pharmacokinetic and bioavailability studies, and is not approved for any indication. All reported trials in advanced solid tumors have been completed.
Linifanib targets FLT3, FLT1, FLT4, KDR, CSF1R, and PDGFRB. It is a small molecule inhibitor of these receptor tyrosine kinases. This mechanism is being explored in advanced solid tumors, though the drug remains investigational and has not been approved.
Linifanib is being developed by Abbott Laboratories, which trades under the ticker ABT. Abbott is the sponsor of the clinical trials evaluating linifanib in advanced solid tumors.
Linifanib is in Phase 1 clinical development. Two Phase 1 trials have been completed, and no active trials are currently listed. The drug is investigational and has not received FDA approval for any indication.
Linifanib has been studied in two completed Phase 1 trials: NCT01401933, which examined the effect of rifampin on linifanib pharmacokinetics in patients with advanced or metastatic solid tumors, and NCT01381341, which compared the relative bioavailability of two clinical formulations of linifanib.