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NCT01465802 · ClinicalTrials.gov registry record · Phase 2
Study Of Dacomitinib (PF-00299804) In Advanced NSCLC Patients (Post Chemo Or Select First Line) To Evaluate Prophylactic Intervention On Derm And GI AEs And PRO
A Phase 2 study, sponsored by Pfizer.
- Completed
- Registry status
- Phase 2
- Development phase
- 236
- Enrollment target
NCT01465802: Completed Phase 2 study, sponsored by Pfizer.
NCT01465802 is a Phase 2 study that has completed, run by Pfizer. The registered enrollment target is 236 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (77% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01465802, a Phase 2 study, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 236 participants
- Enrollment target
Study Summary
To assess the impact of prophylactic treatment on the incidence of adverse events in advanced NSCLC patients (post chemotherapy) treated with dacomitinib daily as a single agent. To assess the impact of an interrupted dacomitinib dosing schedule in Cycle 1 on the incidence of adverse events in first-line advanced NSCLC patients with an EGFR mutation (HER-1 mutation, HER-2 mutation or HER-2 amplification).
Primary Outcome
SDAEI of all causality and all grades were evaluated in participants in Cohort I. These SDAEIs included dermatitis acneiform, dry skin, exfoliative rash, nail discoloration, nail disorder, paronychia, pruritus, rash, skin exfoliation, skin fissures, skin infection, skin laceration and skin ulcer. 95% confidence interval (CI) calculated using exact method based on binomial distribution. After protocol amendment 1, Arm C was removed from Cohort I and enrollment to Arm C was terminated. Only 7 pa
Interventions
- DRUG Doxycycline
- DRUG Dacomitinib
- DRUG Probiotic
- DRUG Alclometasone cream
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 236 participants |
| Start Date | 2011-12-26 |
| Est. Completion | 2015-05-18 |
| Phase | Phase 2 |
What the finished NCT01465802 record still lists
NCT01465802 is an interventional study that assigns participants to a tested intervention. The registered 236 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (77% higher).
The record links to 0 conditions, and to 4 interventions - of which Doxycycline is the first listed.
NCT01465802 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01465802 about?
NCT01465802 is a clinical study titled "Study Of Dacomitinib (PF-00299804) In Advanced NSCLC Patients (Post Chemo Or Select First Line) To Evaluate Prophylactic Intervention On Derm And GI AEs And PRO". To assess the impact of prophylactic treatment on the incidence of adverse events in advanced NSCLC patients (post chemotherapy) treated with dacomitinib daily as a single agent. To assess the impact of an interrupted dacomitinib dosing schedule in Cycle 1 on the incidence of adverse events in first...
What is the current status of trial NCT01465802?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 236 participants. The study started on 2011-12-26. Estimated completion is 2015-05-18.
What interventions are being tested in trial NCT01465802?
The interventions under investigation include: Doxycycline (DRUG), Dacomitinib (DRUG), Probiotic (DRUG), Alclometasone cream (DRUG).
Who is sponsoring clinical trial NCT01465802?
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 NCT01465802's enrollment target sits among peer trials
236 255th of 2000 higher than 1,746 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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