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A PHASE 1B STUDY OF PF-05082566 IN COMBINATION WITH MOGAMULIZUMAB (KW-0761) IN PATIENTS WITH ADVANCED SOLID TUMORS
This study is a Phase 1b, open label, multi center, multi-dose trial designed to estimate the maximum tolerated dose (MTD) and select the recommended dose for phase 2 (RP2D) investigations of PF- 05082566 in combination with KW-0761 (mogamulizumab) in patients with advanced solid tumors. Once the MTD of PF-05082566 administered in combination with KW-0761 is estimated (dose finding), one or more expansion cohorts of patients with selected advanced solid tumors (dose-expansion ) will be enrolled to further characterize the combination in term of safety profile, anti tumor activity, pharmacokinetics, pharmacodynamics and biomarkers modulation.
Details
| Lead sponsor | Pfizer |
|---|---|
| Phase | Phase 1 |
| Status | TERMINATED |
| Enrolment | 24 |
| Start date | 2015-05 |
| Completion | 2017-10 |
Conditions
- Advanced/Metastatic Solid Tumors
Interventions
- PF-05082566
- KW-0761
Primary outcomes
- Number of Participants With Dose Limiting Toxicities (DLT) — First 2 Cycles (28 days in each cycle)
DLTs was defined as any of the following adverse events (AEs) according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 at first 2 Cycles. Hematologic: (1) Grade 4 neutropenia lasting \>7 days; (2) Febrile neutropenia, defined as absolute neutrophil count (ANC) \<1000/mm3 with a single temperature of \>38.3 degrees C (101 degrees F) or a sustained temperature of \>=38 degrees C (100.4 degrees F) for more than 1 hour; (3) Grade \>=3 neutropenic infection; (4) Grade \>=3 thrombocytopenia with bleeding; (5) Grade 4 thrombocytopenia. Non-Hematologic: (1) Grade \>=3 non laboratory toxicities (excluding infusion reactions), except those that had not been maximally treated (eg, nausea, vomiting, diarrhea); (2) Grade \>=3 laboratory abnormalities (other than aspartate aminotransferase \[AST\]/alanine aminotransferase \[ALT\]) if: Medical intervention was required to treat the participant, or The abnormality led to hospitalization; (3) Grade 4 AST and ALT increase.
Countries
United States