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NCT02349633 · ClinicalTrials.gov registry record · Phase 1
Study For Patients With NSCLC EGFR Mutations (Del 19 or L858R +/- T790M)
A Phase 1 study, sponsored by Pfizer.
- Terminated
- Registry status
- Phase 1
- Development phase
- 65
- Enrollment target
NCT02349633: Clinical Trial Phase 1 study, sponsored by Pfizer.
NCT02349633 is a Phase 1 study that was terminated before completion, run by Pfizer. The registered enrollment target is 65 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02349633, a Phase 1 study, was terminated before completion, sponsored by Pfizer.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 65 participants
- Enrollment target
Study Summary
This is a Phase 1/2 study of PF-06747775 as a single agent and in combination with other cancer treatments in patients with advanced EGFRm NSCLC. The overall clinical study consists of a Phase 1 single agent dose-escalation and expansion part to determine the RP2D of PF-06747775 single agent in patients with previously-treated EGFRm NSCLC followed by sequential evaluations of PF-06747775 at the RP2D in 3 different clinical scenarios as detailed below: * Cohort 1: Phase 2 evaluation of PF-06747775 as a single agent in previously untreated patients with advanced EGFRm NSCLC, * Cohort 2: Phase 1b single arm evaluation of PF-06747775 in combination with palbociclib (Cohort 2A) followed by Phase 2 randomized evaluation of PF 06747775 in combination with palbociclib vs PF-06747775 single agent (Cohort 2B) in previously-treated patients with EGFRm NSCLC with a secondary T790M mutation (del 19 and T790M or L858R and T790M), and * Cohort 3: Phase 1b evaluation of PF-06747775 in combination with avelumab in previously-treated patients with EGFRm NSCLC with a secondary T790M mutation (del 19 and T790M or L858R and T790M).
Primary Outcome
DLT was defined as any of the following adverse events (AEs) occurring during the first cycle for Phase 1 dose-escalation cohorts, Japan LIC and Phase 1b Cohort 3, or the first 2 cycles for Phase 1b Cohort 2A of treatment, and considered attributable to study intervention: Grade 4 neutropenia \>7 days; febrile neutropenia; Grade \>=3 thrombocytopenia with bleeding; Grade 4 thrombocytopenia; Grade \>=3 non-hematologic toxicities; Grade 4 rash, mucositis, or diarrhea; failure to receive at least 7
Interventions
- DRUG Palbociclib
- DRUG Avelumab
- DRUG PF-06747775
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 65 participants |
| Start Date | 2015-05-14 |
| Est. Completion | 2020-05-28 |
| Phase | Phase 1 |
Why NCT02349633 stopped before completion
NCT02349633 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 65 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.
The record links to 0 conditions, and to 3 interventions - of which Palbociclib is the first listed.
NCT02349633 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02349633 about?
NCT02349633 is a clinical study titled "Study For Patients With NSCLC EGFR Mutations (Del 19 or L858R +/- T790M)". This is a Phase 1/2 study of PF-06747775 as a single agent and in combination with other cancer treatments in patients with advanced EGFRm NSCLC. The overall clinical study consists of a Phase 1 single agent dose-escalation and expansion part to determine the RP2D of PF-06747775 single agent in pati...
What is the current status of trial NCT02349633?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 65 participants. The study started on 2015-05-14. Estimated completion is 2020-05-28.
What interventions are being tested in trial NCT02349633?
The interventions under investigation include: Palbociclib (DRUG), Avelumab (DRUG), PF-06747775 (DRUG).
Who is sponsoring clinical trial NCT02349633?
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 NCT02349633's enrollment target sits among peer trials
65 798th of 2000 higher than 1,193 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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