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NCT01970865 · ClinicalTrials.gov registry record · Phase 1
A Study Of PF-06463922 An ALK/ROS1 Inhibitor In Patients With Advanced Non Small Cell Lung Cancer With Specific Molecular Alterations
A Phase 1 study, sponsored by Pfizer.
- Completed
- Registry status
- Phase 1
- Development phase
- 364
- Enrollment target
NCT01970865: Completed Phase 1 study, sponsored by Pfizer.
NCT01970865 is a Phase 1 study that has completed, run by Pfizer. The registered enrollment target is 364 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (507% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01970865, a Phase 1 study, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 364 participants
- Enrollment target
Study Summary
Phase 1 and 2 trial to study the safety, pharmacokinetics, pharmacodynamics, patient reported outcomes and efficacy of PF-06463922 in ALK + advanced non-small cell lung cancer patients and ROS1+ advanced non small cell lung cancer patients .
Primary Outcome
DLT: any of following adverse events (AEs) attributable to PF-06463922: (1) hematologic: grade 4 neutropenia for \>7 days; febrile neutropenia; grade\>=3 neutropenic infection; grade\>=3 thrombocytopenia with bleeding; grade 4 thrombocytopenia; (2) non-hematologic: grade\>=3 pancreatitis; grade\>=3 toxicities (excluding grade \>=3 laboratory abnormalities not requiring dose modifications) persisting after optimal treatment with standard medical therapy; symptomatic grade \>=3 QT interval correct
Interventions
- DRUG Crizotinib
- DRUG PF-06463922
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 364 participants |
| Start Date | 2014-01-08 |
| Est. Completion | 2023-05-24 |
| Phase | Phase 1 |
What the finished NCT01970865 record still lists
NCT01970865 is an interventional study that assigns participants to a tested intervention. The registered 364 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (507% higher).
The record links to 0 conditions, and to 2 interventions - of which Crizotinib is the first listed.
NCT01970865 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01970865 about?
NCT01970865 is a clinical study titled "A Study Of PF-06463922 An ALK/ROS1 Inhibitor In Patients With Advanced Non Small Cell Lung Cancer With Specific Molecular Alterations". Phase 1 and 2 trial to study the safety, pharmacokinetics, pharmacodynamics, patient reported outcomes and efficacy of PF-06463922 in ALK + advanced non-small cell lung cancer patients and ROS1+ advanced non small cell lung cancer patients .
What is the current status of trial NCT01970865?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 364 participants. The study started on 2014-01-08. Estimated completion is 2023-05-24.
What interventions are being tested in trial NCT01970865?
The interventions under investigation include: Crizotinib (DRUG), PF-06463922 (DRUG).
Who is sponsoring clinical trial NCT01970865?
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 NCT01970865's enrollment target sits among peer trials
364 88th of 2000 higher than 1,911 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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