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NCT02101034 · ClinicalTrials.gov registry record · Phase 1
PD 0332991 and Cetuximab in Patients With Incurable SCCHN
A Phase 1 study, sponsored by Washington University School of Medicine.
- Completed
- Registry status
- Phase 1
- Development phase
- 96
- Enrollment target
NCT02101034: Completed Phase 1 study, sponsored by Washington University School of Medicine.
NCT02101034 is a Phase 1 study that has completed, run by Washington University School of Medicine. The registered enrollment target is 96 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02101034, a Phase 1 study, has completed, sponsored by Washington University School of Medicine.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 96 participants
- Enrollment target
Study Summary
The purpose of this Phase I/II study is to define the maximum tolerated dose of PD 0332991 given with cetuximab and evaluated the side effects of the combination.
Primary Outcome
MTD is the dose level (DL) immediately below the DL at which 2 patients of a cohort experience dose limiting toxicity (DLT) in the 1st cycle (DLTs) Hematologic DLT is any of the below that occur during the 1st cycle that are possibly, probably, or definitely related to the treatment grade 4 neutropenia ≥7 days grade 4 infection with grade 3/4 neutropenia grade 4 thrombocytopenia with life-threatening bleeding treatment held for \>14 days due to hematologic toxicity febrile neutropenia with tempe
Interventions
- BIOLOGICAL Cetuximab
- DRUG PD 0332991
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 96 participants |
| Start Date | 2014-06-17 |
| Est. Completion | 2023-11-10 |
| Phase | Phase 1 |
What the finished NCT02101034 record still lists
NCT02101034 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 96 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% higher).
The record links to 0 conditions, and to 2 interventions - of which Cetuximab is the first listed.
NCT02101034 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02101034 about?
NCT02101034 is a clinical study titled "PD 0332991 and Cetuximab in Patients With Incurable SCCHN". The purpose of this Phase I/II study is to define the maximum tolerated dose of PD 0332991 given with cetuximab and evaluated the side effects of the combination.
What is the current status of trial NCT02101034?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 96 participants. The study started on 2014-06-17. Estimated completion is 2023-11-10.
What interventions are being tested in trial NCT02101034?
The interventions under investigation include: Cetuximab (BIOLOGICAL), PD 0332991 (DRUG).
Who is sponsoring clinical trial NCT02101034?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02101034's enrollment target sits among peer trials
96 600th of 2000 higher than 1,391 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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