Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
PF-04691502 · 1 trial · 1 indication
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state.
DLT was classified as per common terminology criteria for adverse events (CTCAE) version 4.0 and defined as any of the following events occurring after first dose of study medication and considered at least possibly-related to study medication. Hematological: grade 4 neutropenia (absolute neutrophil count \[ANC\] \<500 cells per cubic millimeter \[cells/mm\^3\]) for 1 week or greater, febrile neutropenia (fever \>=38.5 degree celsius with ANC \<1000/mm\^3), grade 3 (50,000 cells/mm\^3) and grade 4 (\<25,000 cells/mm\^3) thrombocytopenia; Non-Hematologic: grade 3 or 4 nausea, vomiting, or diarrhea and any clinically significant grade 3 or greater non-hematologic toxicity, despite the use of adequate/maximal medical intervention and/or prophylaxis, and any persistent, intolerable PF-04691502 related toxicity which delayed retreatment for \>14 days.
RP2D was determined based on the safety profile and pharmacodynamic findings, as per investigator's discretion.
| Arm | Type | Description |
|---|---|---|
| PF-04691502 Treatment | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| PF-04691502 | DRUG | Once daily continuous dosing. Dose escalation to Maximally tolerated dose (MTD) until progression or discontinuation. |
Inclusion Criteria: * Patients with a histologically or cytologically confirmed malignant solid tumor for which there is no currently approved treatment or which is unresponsive to currently approved therapies. * Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-1 * Female patient...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| GE Healthcare Technologies Inc. | GEHC | 1 | PHASE1 | GEH200520/ GEH200521- Part A |
| Zimmer Biomet Holdings, Inc. | ZBH | 1 | - | Undisclosed |
| Ascentage Pharma Group International Unsponsored ADR | AAPG | 1 | PHASE1 | Olverembatinib |
PF-04691502 is an investigational small molecule being developed for the treatment of cancer. It is intended for use in oncology, targeting cancer patients. The drug is currently in clinical development, having completed a Phase 1 trial to assess its safety and tolerability in cancer patients.
PF-04691502 is being developed by Pfizer, Inc., a pharmaceutical company listed on the New York Stock Exchange under the ticker symbol PFE. Pfizer is responsible for the clinical development of this investigational oncology drug.
PF-04691502 is in Phase 1 of clinical development. It has completed a Phase 1 trial, which was an uncontrolled, non-randomized study. The drug is still investigational and has not been approved by regulatory authorities for commercial use.
PF-04691502 has been studied in one clinical trial, identified as NCT00927823. This was a Phase 1 study titled "A Trial To Assess Safety And Tolerability Of PF-04691502 In Cancer Patients," which has been completed. The trial enrolled 37 participants in the United States.
PF-04691502 is not FDA approved. It is an investigational drug that has completed a Phase 1 clinical trial. The drug remains in clinical development, and its safety and efficacy have not been fully established for regulatory approval.