Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
PF-03814735 · 1 trial · 1 indication
DLT defined as any of the following during the first cycle of treatment and attributable to PF-03814735: Grade (Gr) 4 neutropenia (absolute neutrophil count \[ANC\] \<500 cells/mm\^3) for \>7 days or febrile neutropenia (ANC \<1000/mm\^3, fever ≥38 degrees Celsius; neutropenic infection (ANC \<1000/mm\^3); Gr 4 thrombocytopenia (platelets \<25,000 cells/mm\^3); ≥Gr 3 nausea, vomiting, or diarrhea, despite optimal antiemetic, anti-diarrheal support; ≥20% decrease in left ventricular ejection fraction compared to baseline; other non-hematological toxicity; any Gr ≥3 adverse event; or failure to recover.
| Arm | Type | Description |
|---|---|---|
| Single arm dose escalation | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| PF-03814735 | DRUG | 1, 5, and 25 mg gelatin capsules administered orally once a day from day 1 to day 5, or from day 1 to day 10 every 3 weeks until disease progression or unacceptable toxicity. |
Inclusion Criteria: * Metastatic solid tumor resistant to standard therapy or for which no standard therapy is available * Adequate bone marrow, liver and kidney function Exclusion Criteria: * Brain metastases that are symptomatic and/or require treatment with steroids and/or anticonvulsants, or ...
| 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 |
PF-03814735 is an investigational small molecule developed by Pfizer, Inc. (NYSE: PFE) for the treatment of advanced solid tumors. It is an Aurora kinase inhibitor that was studied in a single Phase 1 clinical trial. It is not an approved therapy and remains an early-stage oncology research compound.
PF-03814735 was studied for the treatment of advanced solid tumors in adults. Its only clinical trial enrolled patients with solid tumors across sites in the United States and Belgium. Because the program only reached Phase 1, PF-03814735 has no approved uses and is not available as a marketed treatment.
PF-03814735 targets Aurora kinase A (AURKA) and Aurora kinase B (AURKB). It acts as an inhibitor of these enzymes, which regulate cell division. By blocking AURKA and AURKB activity, the compound was designed to interfere with mitotic progression in tumor cells, a mechanism explored in oncology research.
PF-03814735 is developed by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker PFE. Pfizer sponsored the Phase 1 study of the compound. No partner or licensing arrangement for PF-03814735 is disclosed in the available program information.
PF-03814735 is in Phase 1 development. It has completed one Phase 1 trial and has no active trials. The compound is investigational and has not been approved by the FDA or any other regulatory agency for any indication.
PF-03814735 was evaluated in one completed Phase 1 trial, NCT00424632, titled a Phase 1 study of Aurora kinase inhibitor PF-03814735 in patients with advanced solid tumors. The trial enrolled 57 patients aged 18 years and older in the United States and Belgium. It was an uncontrolled, non-randomized study.