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PI3Kγ inhibitor

IPI-549 for Head and Neck Cancers

Phase 2

Recruiting

Led By Ezra Cohen, MD

Research Sponsored by Ezra Cohen

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

Study Summary

This trial will investigate whether IPI-549 is an effective treatment against cancer.

Eligible Conditions

Head and Neck Cancers
Carcinoma
Head and Neck Squamous Cell Carcinoma
HPV-Related Malignancy
Squamous Cell Carcinoma

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

PI3K-y changes

Secondary outcome measures

Changes of Myeloid composition

Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

changes in T cell composition

Trial Design

1Treatment groups

Experimental Treatment

Group I: Arm A: IPI-549 40 mg PO qdailyExperimental Treatment1 Intervention

Patients enrolled in Arm A will receive IPI-549 40 mg by mouth daily for at least 14 days

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

IPI-549

2018

Completed Phase 1

~40

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

The V Foundation for Cancer ResearchOTHER

18 Previous Clinical Trials

1,253 Total Patients Enrolled

Ezra CohenLead Sponsor

4 Previous Clinical Trials

78 Total Patients Enrolled

Ezra Cohen, MD4.8134 ReviewsPrincipal Investigator - University of California, San Diego

13 Previous Clinical Trials

768 Total Patients Enrolled

4Patient Review

Dr Raush was very amiable and gentle. This was my first visit to an optometrist in years, but they were able to take care of everything I needed — including my DMV form. I had a lovely time.

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the total number of people allowed to enroll in this clinical trial?

"The clinical trial is currently recruiting patients, with a posting date of March 6th, 2020 and an update on July 20th, 2022. They are looking for a total of 15 patients at a single site."

Answered by AI

To the best of your knowledge, are there other on-going or completed studies involving IPI-549?

"Currently, there are 3 clinical trials underway for IPI-549. Of these active studies, 0 are in Phase 3. The 41 locations running trials for this treatment are primarily based in Sevilla and Michigan."

Answered by AI

Are investigators seeking new participants for this clinical trial?

"That is correct. The clinical trial is looking for 15 more participants and is being hosted at 1 site. The information on clinicaltrials.gov shows that the study was posted on 3/6/2020 and was last updated on 7/20/2022."

Answered by AI

Could you please tell me about the risks and side effects of IPI-549?

"IPI-549, which is currently in Phase 2 trials, received a safety score of 2. While there is some evidence supporting its safety, there is no data yet indicating whether or not the medication is effective."

Answered by AI

Have patients undergone this kind of treatment before?

"IPI-549 is being trialed in 3 ongoing studies located in 17 cities and 7 countries. The first study was conducted in 2015 by Infinity Pharmaceuticals, Inc. and completed Phase 1 drug approval with 219 patients. Since then, 1 more study has been completed."

Answered by AI

Recent research and studies

European Journal of CancerJournal

New Response Evaluation Criteria in Solid Tumours: Revised RECIST Guideline (version 1.1)

Eisenhauer, E.A., P. Therasse, J. Bogaerts, L.H. Schwartz, D. Sargent, R. Ford, J. Dancey, et al.. 2009. “New Response Evaluation Criteria in Solid Tumours: Revised RECIST Guideline (version 1.1)”. European Journal of Cancer. Elsevier BV. doi:10.1016/j.ejca.2008.10.026.

Cancer CellJournal

Macrophage Regulation of Tumor Responses to Anticancer Therapies

De Palma, Michele, and Claire E. Lewis. 2013. “Macrophage Regulation of Tumor Responses to Anticancer Therapies”. Cancer Cell. Elsevier BV. doi:10.1016/j.ccr.2013.02.013.

Cancer CellJournal

Receptor Tyrosine Kinases and Tlr/il1rs Unexpectedly Activate Myeloid Cell Pi3kγ, A Single Convergent Point Promoting Tumor Inflammation and Progression

Schmid, Michael C., Christie J. Avraamides, Holly C. Dippold, Irene Franco, Philippe Foubert, Lesley G. Ellies, Lissette M. Acevedo, et al.. 2011. “Receptor Tyrosine Kinases and Tlr/il1rs Unexpectedly Activate Myeloid Cell Pi3kγ, A Single Convergent Point Promoting Tumor Inflammation and Progression”. Cancer Cell. Elsevier BV. doi:10.1016/j.ccr.2011.04.016.

NatureJournal