Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01337050 | Asian Phase I Study Of PF-03446962 | PHASE1 | COMPLETED | 36 | — | — | Jul 1, 2011 | Mar 1, 2014 | Oct 28, 2015 | 2 | Japan, South Korea |
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.
| Arm | Type | Description |
|---|---|---|
| A | EXPERIMENTAL | PF-03446962 |
| 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...