RecruitingPhase 1NCT05172245

Testing the Addition of Ipatasertib to Usual Chemotherapy and Radiation for Head and Neck Cancer

Phase 1/1b Study of AKT Inhibitor Ipatasertib With Chemoradiation for Locally Advanced Head and Neck Cancer


Sponsor

National Cancer Institute (NCI)

Enrollment

46 participants

Start Date

Sep 19, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

This phase I/Ib trial tests the safety and best dose of ipatasertib in combination with the usual treatment approach using chemotherapy together with radiation therapy ("chemo-radiation") in patients with head and neck cancer. Ipatasertib is in a class of medications called protein kinase B (AKT) inhibitors. It may stop the growth of tumor cells and may kill them. Cisplatin, which is a chemotherapy used in this trial, is in a class of medications known as platinum-containing compounds. It works by killing, stopping or slowing the growth of cancer cells. Radiation therapy uses high energy to kill tumor cells and shrink tumors. Giving ipatasertib in combination with chemo-radiation may be better than chemo-radiation alone in treating patients with advanced head and neck cancer.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding ipatasertib — a drug that blocks a cell survival pathway called AKT — to the standard treatment of cisplatin chemotherapy plus radiation improves outcomes in people with locally advanced head and neck squamous cell cancer (HNSCC). **You may be eligible if...** - You are 18 years of age or older - You have confirmed locally advanced head and neck squamous cell cancer of the mouth, throat, voice box, or related areas - You can swallow tablets - You are in good enough health to receive cisplatin-based chemotherapy plus radiation (ECOG 0–1) - You have a life expectancy of more than 3 months - Your blood counts, liver, and kidney function are within acceptable ranges **You may NOT be eligible if...** - Your cancer has spread to distant organs (metastatic disease) - You are unable to tolerate cisplatin chemotherapy or radiation - You have serious heart, kidney, or liver problems - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREBiopsy Procedure

Undergo tumor biopsy

PROCEDUREBiospecimen Collection

Undergo blood sample collection

DRUGCisplatin

Given IV

PROCEDUREComputed Tomography

Undergo CT or PET/CT

DRUGIpatasertib

Given PO

PROCEDUREMagnetic Resonance Imaging

Undergo MRI

PROCEDUREPositron Emission Tomography

Undergo PET/CT

RADIATIONRadiation Therapy

Undergo radiation therapy


Locations(18)

Moffitt Cancer Center

Tampa, Florida, United States

Northwestern University

Chicago, Illinois, United States

University of Kansas Clinical Research Center

Fairway, Kansas, United States

University of Kansas Cancer Center

Kansas City, Kansas, United States

University of Kansas Hospital-Westwood Cancer Center

Westwood, Kansas, United States

University of Kentucky/Markey Cancer Center

Lexington, Kentucky, United States

University of Maryland/Greenebaum Cancer Center

Baltimore, Maryland, United States

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, United States

Rutgers New Jersey Medical School

Newark, New Jersey, United States

Montefiore Medical Center-Einstein Campus

The Bronx, New York, United States

Montefiore Medical Center - Moses Campus

The Bronx, New York, United States

Carolinas Medical Center/Levine Cancer Institute

Charlotte, North Carolina, United States

Atrium Health Cabarrus/LCI-Concord

Concord, North Carolina, United States

University of Cincinnati Cancer Center-UC Medical Center

Cincinnati, Ohio, United States

University of Cincinnati Cancer Center-West Chester

West Chester, Ohio, United States

University of Virginia Cancer Center

Charlottesville, Virginia, United States

VCU Massey Comprehensive Cancer Center

Richmond, Virginia, United States

University Health Network-Princess Margaret Hospital

Toronto, Ontario, Canada

View Full Details on ClinicalTrials.gov

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NCT05172245


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