CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 16 enrolled
Drug / intervention
IPI-549drug
Likely dose
IPI-549 40mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03795610
NCT03795610Phase 2Completed
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Phase 2 Window of Opportunity Study of IPI-549 in Patients With Locally Advanced HPV+ and HPV- Head and Neck Squamous Cell Carcinoma

Assuntina G. Sacco, MD·interventional·Posted Jan 8, 2019·Updated Jul 25, 2025

In Brief

A Phase 2 clinical trial evaluating IPI-549 for Head and Neck Squamous Cell Carcinoma and 7 related conditions. Completed, enrolled 16 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHead 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
CountriesUnited States
CollaboratorsThe V Foundation for Cancer Research

Timeline

Phase 2CompletedFinished
20192020202120222023202420252026
First PostedJan 8, 2019
Enrollment StartMar 6, 2020
Primary CompletionDec 22, 2022
Study CompletionAug 24, 2023
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 7.5 years ago

Interventions

IPI-549drug

40mg by mouth (PO) every day (QD) for at least 14 days