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NCT02444793 · ClinicalTrials.gov registry record · Phase 1
A Study of PF-05082566 In Combination With Mogamulizumab In Patients With Advanced Solid Tumors
A Phase 1 study, sponsored by Pfizer.
- Terminated
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
NCT02444793: Clinical Trial Phase 1 study, sponsored by Pfizer.
NCT02444793 is a Phase 1 study that was terminated before completion, run by Pfizer. The registered enrollment target is 24 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02444793, a Phase 1 study, was terminated before completion, sponsored by Pfizer.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
Study 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.
Primary Outcome
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
Interventions
- DRUG PF-05082566
- DRUG KW-0761
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2015-05 |
| Est. Completion | 2017-10 |
| Phase | Phase 1 |
Why NCT02444793 stopped before completion
NCT02444793 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower).
The record links to 0 conditions, and to 2 interventions - of which PF-05082566 is the first listed.
NCT02444793 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02444793 about?
NCT02444793 is a clinical study titled "A Study of PF-05082566 In Combination With Mogamulizumab 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 MT...
What is the current status of trial NCT02444793?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2015-05. Estimated completion is 2017-10.
What interventions are being tested in trial NCT02444793?
The interventions under investigation include: PF-05082566 (DRUG), KW-0761 (DRUG).
Who is sponsoring clinical trial NCT02444793?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02444793's enrollment target sits among peer trials
24 1520th of 2000 higher than 405 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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