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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 is a Phase 1 study that has completed, run by University of Chicago. The registered enrollment target is 12 participants.

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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

Interventions

  • BIOLOGICAL cetuximab
  • DRUG PI3K inhibitor BKM120

Trial Details

FieldValue
Enrollment Target 12 participants
Start Date 2013-05
Est. Completion 2020-09
Phase Phase 1

Sponsor

University of Chicago

796 total trials

What the Registry Record Tells You About NCT01816984

The ClinicalTrials.gov registry entry for NCT01816984 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Chicago, which has 796 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which cetuximab is the first listed.

NCT01816984 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.