Alpelisib in Treating Participants With Transorally Resectable HPV-Associated Stage I-IVA Oropharyngeal Cancer

Recruiting in Palo Alto (17 mi)

Overseen byRicklie Julian, MD

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: University of Arizona

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

This phase II trial studies how well alpelisib works in treating participants with human papillomavirus(HPV)-associated stage I-IVA head and neck cancer that can be removed by surgery. Alpelisib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Research Team

Ricklie Julian, MD

Principal Investigator

The University of Arizona Medical Center-University Campus

Eligibility Criteria

Inclusion Criteria

Cytologic or histologic diagnosis of oropharyngeal squamous cell carcinoma

Clinical stage I-IVa p16+ oropharyngeal squamous cell carcinoma, based upon the American Joint Committee on Cancer (AJCC) staging manual, 7th edition

No evidence of distant metastatic disease

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Treatment Details

Interventions

Alpelisib (PI3K Inhibitor)

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Treatment (Alpelisib)Experimental Treatment4 Interventions

Participants receive Alpelisib PO QD for 14-21 days in the absence of disease progression of unacceptable toxicity and then undergo surgery. Participants may receive Alpelisib for up to 28 days if surgery is delayed.