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NCT02282371 · ClinicalTrials.gov registry record · Phase 1

Cetuximab + BYL719 + IMRT (Intensity-Modulated Radiation Therapy) in Stage III/IVB Head and Neck Squamous Cell Cancer (HNSCC)

A Phase 1 study, sponsored by Memorial Sloan Kettering Cancer Center.

Completed
Registry status
Phase 1
Development phase
16
Enrollment target

NCT02282371: Completed Phase 1 study, sponsored by Memorial Sloan Kettering Cancer Center.

NCT02282371 is a Phase 1 study that has completed, run by Memorial Sloan Kettering Cancer Center. The registered enrollment target is 16 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (73% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02282371, a Phase 1 study, has completed, sponsored by Memorial Sloan Kettering Cancer Center.

COMPLETED
Registry status
Phase 1
Development phase
16 participants
Enrollment target

Study Summary

This is a phase 1b study, which means that the purpose of the study is to establish the maximum dose of a pill drug called BYL719, when given with a standard treatment for patients with head and neck squamous cell cancer.

Primary Outcome

Patients will be treated in cohorts of size three to six and the dosage will be escalated if the clinical toxicity is acceptable.

Interventions

  • DRUG Cetuximab
  • DRUG BYL719
  • RADIATION IMRT (Intensity-Modulated Radiation Therapy)

Trial Details

FieldValue
Enrollment Target 16 participants
Start Date 2014-10-30
Est. Completion 2021-10-22
Phase Phase 1
Memorial Sloan Kettering Cancer Center

1,884 total trials

What the finished NCT02282371 record still lists

NCT02282371 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (73% lower).

The record links to 0 conditions, and to 3 interventions - of which Cetuximab is the first listed.

NCT02282371 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02282371 about?

NCT02282371 is a clinical study titled "Cetuximab + BYL719 + IMRT (Intensity-Modulated Radiation Therapy) in Stage III/IVB Head and Neck Squamous Cell Cancer (HNSCC)". This is a phase 1b study, which means that the purpose of the study is to establish the maximum dose of a pill drug called BYL719, when given with a standard treatment for patients with head and neck squamous cell cancer.

What is the current status of trial NCT02282371?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 16 participants. The study started on 2014-10-30. Estimated completion is 2021-10-22.

What interventions are being tested in trial NCT02282371?

The interventions under investigation include: Cetuximab (DRUG), BYL719 (DRUG), IMRT (Intensity-Modulated Radiation Therapy) (RADIATION).

Who is sponsoring clinical trial NCT02282371?

This trial is sponsored by Memorial Sloan Kettering Cancer Center, which has 1,884 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02282371's enrollment target sits among peer trials

16 1786th of 2000 higher than 203 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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Source: ClinicalTrials.gov NCT02282371, the US trial registry maintained by the National Library of Medicine. NCT02282371 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.