Approval Probability
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ML Risk
PF-03446962 · 2 trials · 2 indications
The MTD was defined as the highest dose of PF-03446962 associated with the occurrence of Dose Limiting Toxicities (DLTs) in at most 1 of 6 participants with the next higher dose having at least 2/3 or 2/6 participants experiencing DLTs (that is (i.e.) Maximum Administrated Dose). DLT is defined if the participants meets the following criteria during the first 6 weeks of treatment, possibly attributable to PF-03446962. Neutropenia grade 4 (less than \[\< \])500/cubic millimeter \[mm\^ 3\]) lasting for greater than equal to (\>=) 8 days; Febrile Neutropenia \>= Grade 3; Neutropenic Infection \>= Grade 3; Grade 4 thrombocytopenia (\<25,000/mm\^3); Grade 3 thrombocytopenia (\<50,000/mm\^3) with active bleeding; Grade 3 or higher non-hematological toxicity.
RP2D was determined by a comprehensive assessments based on all the safety data, efficacy data, pharmacokinetics profile and biomarker data using blood and tumor samples.
MTD was defined as highest dose level for which no more than 1 participant in a dose cohort experienced DLT and at least 2 out of 3/6 participants in the next higher dose. DLT was defined as any of the following events occurring during the first 42 days of study drug: any grade greater than or equal to 3 hematologic and non-hematologic toxicity, all non-disease-related adverse events (AEs).
RP2D was defined as the lower dose level to MTD based on the safety profile.
| Arm | Type | Description |
|---|---|---|
| A | EXPERIMENTAL | PF-03446962 |
| 1 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| PF-03446962 | DRUG | PF 03446962 given by a 1 hour IV infusion. Each patient will initially receive the first dose on Cycle 1 Day 1 with a 28 day observation period. Cycle 2 will start on Day 29. The dosing interval will be 14 days for Cycle 2 and subsequent cycles. |
Inclusion Criteria: * Confirmed diagnosis of stomach cancer * advanced/metastasis solid tumor refractory or intolerant to established therapy * adequate blood chemistry, blood counts and kidney/liver function * willing to participate to study requirements and sign an informed consent document Excl...
| 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-03446962 is an investigational small molecule being studied for the treatment of advanced solid tumors and neoplasms. It is being developed by Pfizer, Inc. (NYSE: PFE) and has completed Phase 1 clinical trials. The drug is not approved and remains in clinical development.
PF-03446962 is being developed by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker symbol PFE. The drug is an investigational oncology small molecule that has completed Phase 1 trials for advanced solid tumors and neoplasms.
PF-03446962 is in Phase 1 clinical development. It has completed two Phase 1 trials, one with 70 patients in the United States, Italy, and South Korea, and another with 36 patients in Japan and South Korea. The drug is investigational and not yet approved.
PF-03446962 has completed two Phase 1 clinical trials. The first, NCT00557856, enrolled 70 patients with advanced solid tumors in the United States, Italy, and South Korea. The second, NCT01337050, enrolled 36 patients with neoplasms in Japan and South Korea. Both trials are completed.
PF-03446962 is not FDA approved. It is an investigational drug that has completed Phase 1 clinical trials for advanced solid tumors and neoplasms. The drug is still in clinical development and has not been approved for any use.