MedTrace Logo

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

NCT03601507 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2024-04-17

Study results available
· View outcomes & findings →

Summary

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.

Conditions

  • CDKN2A-p16 Positive
  • HPV Positive Oropharyngeal Squamous Cell Carcinoma
  • Stage I Oropharyngeal Squamous Cell Carcinoma AJCC V7
  • Stage II Oropharyngeal Squamous Cell Carcinoma AJCC V7
  • Stage III Oropharyngeal Squamous Cell Carcinoma AJCC v7
  • Stage IVA Oropharyngeal Squamous Cell Carcinoma AJCC v7

Interventions

DRUG

Alpelisib

Given PO

OTHER

Laboratory Biomarker Analysis

Correlative studies

OTHER

Pharmacodynamic Study

Correlative studies

PROCEDURE

Therapeutic Conventional Surgery

Undergo surgery

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • University of Arizona

    lead OTHER

Principal Investigators

  • Ricklie Julian, MD · The University of Arizona Medical Center-University Campus

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-11
Primary Completion
2022-05-24
Completion
2022-05-24
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03601507 on ClinicalTrials.gov