Trials / Terminated
TerminatedNCT02444793
A Study of PF-05082566 In Combination With Mogamulizumab In Patients With Advanced Solid Tumors
A PHASE 1B STUDY OF PF-05082566 IN COMBINATION WITH MOGAMULIZUMAB (KW-0761) IN PATIENTS WITH ADVANCED SOLID TUMORS
- Status
- Terminated
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 24 (actual)
- Sponsor
- Pfizer · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | PF-05082566 | Part 1: PF-05082566 dose escalation; Increased doses of PF-05082566 IV are administered at appropriate intervals. Part 2: MTD of PF-05082566 IV established in Part 1 is administered. |
| DRUG | KW-0761 | Part 1: KW-0761 IV administered at appropriate intervals. Part 2: KW-0761 IV administered at appropriate intervals at the MTD dose for the combination. |
Timeline
- Start date
- 2015-05-01
- Primary completion
- 2017-09-01
- Completion
- 2017-10-01
- First posted
- 2015-05-14
- Last updated
- 2019-02-27
- Results posted
- 2019-02-15
Locations
21 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT02444793. Inclusion in this directory is not an endorsement.