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NCT02499120 · ClinicalTrials.gov registry record · Phase 2
Safety And Efficacy Study Of Palbociclib Plus Cetuximab Versus Cetuximab To Treat Head And Neck Cancer
A Phase 2 study, sponsored by Pfizer.
- Completed
- Registry status
- Phase 2
- Development phase
- 125
- Enrollment target
NCT02499120: Completed Phase 2 study, sponsored by Pfizer.
NCT02499120 is a Phase 2 study that has completed, run by Pfizer. The registered enrollment target is 125 participants, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02499120, a Phase 2 study, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 125 participants
- Enrollment target
Study Summary
The purpose of this study is to determine whether the combination of palbociclib with cetuximab is superior to cetuximab in prolonging overall survival in HPV-negative, cetuximab-naive patients with recurrent/metastatic squamous cell carcinoma of the head and neck.
Primary Outcome
OS was defined as the time from the date of randomization to the date of death due to any cause. OS (in months) was calculated as (date of death - randomization date +1)/30.4. For participants lacking survival data beyond the date of their last follow-up, the OS time was censored on the last date they were known to be alive. Participants lacking survival data beyond randomization had their OS times be censored at randomization. Estimates of OS and its 95% confidence interval were determined usin
Interventions
- DRUG Placebo
- DRUG Cetuximab
- DRUG palbociclib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 125 participants |
| Start Date | 2015-09-10 |
| Est. Completion | 2022-09-07 |
| Phase | Phase 2 |
What the finished NCT02499120 record still lists
NCT02499120 is an interventional study that assigns participants to a tested intervention. The registered 125 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT02499120 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02499120 about?
NCT02499120 is a clinical study titled "Safety And Efficacy Study Of Palbociclib Plus Cetuximab Versus Cetuximab To Treat Head And Neck Cancer". The purpose of this study is to determine whether the combination of palbociclib with cetuximab is superior to cetuximab in prolonging overall survival in HPV-negative, cetuximab-naive patients with recurrent/metastatic squamous cell carcinoma of the head and neck.
What is the current status of trial NCT02499120?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 125 participants. The study started on 2015-09-10. Estimated completion is 2022-09-07.
What interventions are being tested in trial NCT02499120?
The interventions under investigation include: Placebo (DRUG), Cetuximab (DRUG), palbociclib (DRUG).
Who is sponsoring clinical trial NCT02499120?
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 NCT02499120's enrollment target sits among peer trials
125 558th of 2000 higher than 1,437 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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