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PI3K Inhibitor

Cetuximab + BYL719 + IMRT for Head and Neck Cancers

Phase 1
Waitlist Available
Led By David Pfister, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

Study Summary

This trial is testing a new cancer drug to see what the maximum dose is that can be given to patients with head and neck squamous cell cancer, in combination with a standard treatment.

Eligible Conditions
  • Head and Neck Cancers

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
determine the phase II-recommended dose of BYL719
Secondary outcome measures
Adverse events

Trial Design

1Treatment groups
Experimental Treatment
Group I: Cetuximab + BYL719 + IMRTExperimental Treatment3 Interventions
Cetuximab loading dose, 400 mg/m2 intravenously (IV). IMRT, 1 fraction/day, up to total of approximately 70 Gy, over approximately 33 treatment days Cetuximab 250 mg/m2 weekly IV X 7 weeks Daily BYL719, according to dose escalation scheme followup clinic visits every 3 months for 2 years,every 6 months for the next 3 years, and annually thereafter.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cetuximab
FDA approved
Alpelisib
FDA approved
IMRT (Intensity-Modulated Radiation Therapy)
2014
Completed Phase 1
~20

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsIndustry Sponsor
2,865 Previous Clinical Trials
4,199,271 Total Patients Enrolled
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,938 Previous Clinical Trials
588,359 Total Patients Enrolled
David Pfister, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
5 Previous Clinical Trials
125 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Cetuximab + BYL719 + IMRT (Intensity-Modulated Radiation Therapy) in Stage III/IVB Head and Neck Squamous Cell Cancer (HNSCC)
2014. "Cetuximab + BYL719 + IMRT (Intensity-Modulated Radiation Therapy) in Stage III/IVB Head and Neck Squamous Cell Cancer (HNSCC)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02282371.
~2 spots leftby May 2025
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