CompletedPhase 2

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

United States16 participantsStarted 2020-03-06

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion 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. Exclusion Criteria: * 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

What they're measuring

Participants Experiencing Adverse Events

Timeframe: 7 weeks

Trial details

NCT IDNCT03795610

SponsorAssuntina G. Sacco, MD

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-12-22

Results submitted2025-06-09