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 | 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 |
PF-03814735 is an investigational small molecule being studied for the treatment of advanced solid tumors. It is an aurora kinase inhibitor that was evaluated in a Phase 1 clinical trial in patients with advanced solid tumors. The drug is being developed by Pfizer, Inc. and is currently in clinical development.
PF-03814735 targets aurora kinases, which are enzymes involved in cell division. By inhibiting these kinases, the drug aims to disrupt the proliferation of cancer cells. This mechanism is being investigated as a potential treatment approach for advanced solid tumors.
PF-03814735 is being developed by Pfizer, Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol PFE. The drug is an investigational small molecule in Phase 1 clinical development for the treatment of solid tumors.
PF-03814735 is in Phase 1 clinical development. It has completed a Phase 1 study in patients with advanced solid tumors. The drug is investigational and has not been approved by regulatory authorities. It remains in clinical development as a potential oncology treatment.
PF-03814735 has been studied in one completed clinical trial, NCT00424632, titled "Phase 1 Study Of Aurora Kinase Inhibitor PF-03814735 In Patients With Advanced Solid Tumors." This trial enrolled 57 participants with solid tumors and was conducted in the United States and Belgium.