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NCT01816984 · ClinicalTrials.gov registry record · Phase 1
PI3K Inhibitor BKM120 and Cetuximab in Treating Patients With Recurrent or Metastatic Head and Neck Cancer
A Phase 1 study, sponsored by University of Chicago.
- Completed
- Registry status
- Phase 1
- Development phase
- 12
- Enrollment target
NCT01816984: Completed Phase 1 study, sponsored by University of Chicago.
NCT01816984 is a Phase 1 study that has completed, run by University of Chicago. The registered enrollment target is 12 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01816984, a Phase 1 study, has completed, sponsored by University of Chicago.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 12 participants
- Enrollment target
Study Summary
This pilot randomized phase I/II trial studies the side effects and best dose of PI3K inhibitor BKM120 when given together with cetuximab and to see how well it works in treating patients with recurrent or metastatic head and neck cancer. PI3K inhibitor BKM120 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumors to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving PI3K inhibitor BKM120 together with cetuximab may kill more tumor cells
Primary Outcome
Performed using snap frozen tissue samples using the well-established PamGene Kinase array platform available in the Salgia/Seiwert laboratories.
Interventions
- BIOLOGICAL cetuximab
- DRUG PI3K inhibitor BKM120
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2013-05 |
| Est. Completion | 2020-09 |
| Phase | Phase 1 |
What the finished NCT01816984 record still lists
NCT01816984 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower).
The record links to 0 conditions, and to 2 interventions - of which cetuximab is the first listed.
NCT01816984 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01816984 about?
NCT01816984 is a clinical study titled "PI3K Inhibitor BKM120 and Cetuximab in Treating Patients With Recurrent or Metastatic Head and Neck Cancer". This pilot randomized phase I/II trial studies the side effects and best dose of PI3K inhibitor BKM120 when given together with cetuximab and to see how well it works in treating patients with recurrent or metastatic head and neck cancer. PI3K inhibitor BKM120 may stop the growth of tumor cells by b...
What is the current status of trial NCT01816984?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2013-05. Estimated completion is 2020-09.
What interventions are being tested in trial NCT01816984?
The interventions under investigation include: cetuximab (BIOLOGICAL), PI3K inhibitor BKM120 (DRUG).
Who is sponsoring clinical trial NCT01816984?
This trial is sponsored by University of Chicago, which has 796 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01816984's enrollment target sits among peer trials
12 1852nd of 2000 higher than 90 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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