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

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.

Conditions

Head and Neck Squamous Cell Carcinoma, Head and Neck Cancer, Head and Neck Carcinoma, Head and Neck Cancer Stage IV, Head and Neck Cancer Stage III, HPV-Related Carcinoma, HPV-Related Malignancy, HPV-Related Squamous Cell Carcinoma

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Head and Neck Squamous Cell Carcinoma
Intervention / Treatment

-

Contacts and Locations

La Jolla

UC San Diego Moores Cancer Center, La Jolla, California, United States, 92093

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Ezra Cohen,

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

Study Record Dates

2023-06