COMPLETED

IPI-549 in Patients With Locally Advanced HPV+ and HPV- Head and Neck Squamous Cell Carcinoma

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this study is to investigate how effective the study drug IPI-549 is against types of cancers. IPI-549 is considered experimental because it is not approved by the US Food and Drug Administration (FDA) for the treatment of cancer. Patients will be treated with 2 weeks of IPI-549, a specific PI3Kγ inhibitor. Tumor tissue for research purposes through core biopsies will be obtained prior to initiation of IPI-549 and at surgery.

Official Title

Phase 2 Window of Opportunity Study of IPI-549 in Patients With Locally Advanced HPV+ and HPV- Head and Neck Squamous Cell Carcinoma

Quick Facts

Study Start:2020-03-06

Study Completion:2023-08-24

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT03795610

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Have locally advanced that is amenable to surgical resection * Must be able to swallow tablets * Must be able to undergo a core tumor biopsy. * Must have adequate organ function.	* Diagnosis of cutaneous squamous cell carcinoma (SCC) or Epstein-Barr virus (EBV) related nasopharynx cancer. * Planned major surgery within 4 weeks prior to initiation of study drug * Patients treated with chemotherapy, biologic therapy, or other investigational agent within \< 28 days of starting study drug * History of infection with human immunodeficiency virus (HIV), hepatitis B, or hepatitis C virus (HCV) * On going treatment with chronic immunosuppressants (e.g., cyclosporine) or systemic steroids * Prior surgery or gastrointestinal dysfunction that may affect drug absorption (e.g. gastric bypass surgery, gastrectomy) * Female subjects who are pregnant or breastfeeding * Concurrent active malignancy other than nonmelanoma skin cancer, carcinoma in situ of the cervix, or prostate intraepithelial neoplasia

Inclusion Criteria

Exclusion Criteria

* Have locally advanced that is amenable to surgical resection
* Must be able to swallow tablets
* Must be able to undergo a core tumor biopsy.
* Must have adequate organ function.

* Diagnosis of cutaneous squamous cell carcinoma (SCC) or Epstein-Barr virus (EBV) related nasopharynx cancer.
* Planned major surgery within 4 weeks prior to initiation of study drug
* Patients treated with chemotherapy, biologic therapy, or other investigational agent within \< 28 days of starting study drug
* History of infection with human immunodeficiency virus (HIV), hepatitis B, or hepatitis C virus (HCV)
* On going treatment with chronic immunosuppressants (e.g., cyclosporine) or systemic steroids
* Prior surgery or gastrointestinal dysfunction that may affect drug absorption (e.g. gastric bypass surgery, gastrectomy)
* Female subjects who are pregnant or breastfeeding
* Concurrent active malignancy other than nonmelanoma skin cancer, carcinoma in situ of the cervix, or prostate intraepithelial neoplasia

Contacts and Locations

Principal Investigator

Ezra Cohen, MD

PRINCIPAL_INVESTIGATOR

University of California, San Diego

Study Locations (Sites)

UC San Diego Moores Cancer Center

La Jolla, California, 92093

United States

Collaborators and Investigators

Sponsor: Assuntina G. Sacco, MD

Ezra Cohen, MD, PRINCIPAL_INVESTIGATOR, University of California, San Diego

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-03-06

Study Completion Date2023-08-24

Study Record Updates