Actively Recruiting
Phase 1/1b Study of AKT Inhibitor Ipatasertib with Chemoradiation for Locally Advanced Head and Neck Cancer
Led by National Cancer Institute (NCI) · Updated on 2026-05-18
46
Participants Needed
18
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and best dose of ipatasertib combined with the usual chemotherapy and radiation treatment in patients with locally advanced head and neck squamous cell carcinoma (HNSCC). This phase I/Ib trial focuses on determining the maximum tolerated dose and recommended phase 2 dose of ipatasertib when added to definitive chemoradiation. The study also aims to assess toxicities, swallowing function, treatment completion, pharmacokinetics, pharmacodynamics, anti-tumor activity, and genetic factors related to treatment response. Participants receive ipatasertib orally either daily or three times a week depending on the dose level, combined with weekly intravenous cisplatin and daily radiation therapy Monday through Friday for 35 sessions over 7 weeks. The study includes a dose escalation phase where doses are adjusted and a dose expansion phase using the recommended dose. Treatment cycles last 28 days, with up to 2 cycles given if no disease progression or severe side effects occur. Imaging scans such as PET/CT, CT, or MRI are performed for screening and follow-up, and blood samples and tumor biopsies are collected during the trial. During the study, patients undergo regular assessments including imaging, blood tests, and biopsies to monitor treatment effects and side effects. After completing treatment, participants are followed for 30 days and then every 3 months for up to 2 years to evaluate long-term outcomes such as swallowing ability, tumor control, survival, and treatment safety. The researchers measure outcomes like dose-limiting toxicities, treatment completion rates, tumor response, and survival rates throughout the study period.
CONDITIONS
Brief Title
Testing the Addition of Ipatasertib to Usual Chemotherapy and Radiation for Head and Neck Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must have confirmed head and neck squamous cell carcinoma with measurable disease
- Oropharyngeal and unknown primary cancers must have HPV testing; eligibility depends on HPV status and cancer stage
- Must be candidate for concurrent cisplatin and radiation therapy
- Able to swallow tablets
- Age 18 years or older
- ECOG performance status 0-1
- Life expectancy greater than 3 months
- Specific blood count and organ function levels met (neutrophils, hemoglobin, platelets, albumin, bilirubin, liver enzymes, clotting tests, creatinine clearance)
- Fasting glucose and hemoglobin A1c within defined limits
- HIV patients on effective therapy with undetectable viral load
- Patients with past or resolved hepatitis B or C under specific conditions
- Prior or concurrent malignancy allowed if unlikely to interfere with study
- Agreement on contraception and abstinence for men and women during and after treatment
- Willingness and ability to sign informed consent
- For dose expansion, agreement to undergo on-treatment biopsies and tumors amenable to biopsy
You will not qualify if you...
- Primary tumors of nasopharynx, salivary, thyroid, parathyroid glands, or skin
- Distant metastases from current cancer
- Prior chemotherapy, radiation, or definitive surgery for current cancer (except prior early stage surgery meeting criteria)
- Chemotherapy or radiation within 6 weeks for another malignancy
- Overlapping radiation fields from prior treatments
- Use of other investigational agents
- Allergic reactions to similar compounds
- Recent treatment with strong CYP3A4 or P-glycoprotein inhibitors or inducers
- Uncontrolled illness or active infection
- Pregnancy or breastfeeding
- Insulin-dependent diabetes
- Active or history of inflammatory bowel disease or active bowel inflammation
- Conditions affecting pill swallowing or absorption
- Significant lung diseases or history of opportunistic infections
- Significant liver disease or active viral hepatitis
- Uncontrolled or untreated high cholesterol or triglycerides
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Duration - Up to 2 cycles of 28 days each, with radiation therapy delivered daily Monday-Friday during weeks 1-7 of each cycle
Participants receive the study drugs ipatasertib orally and cisplatin intravenously combined with daily radiation therapy for head and neck cancer. Treatment is given in cycles with active drug and radiation administration over approximately 7 weeks per cycle.
Weekly visits for cisplatin administration, daily radiation therapy visits Monday through Friday for 7 weeks, and daily or thrice weekly ipatasertib dosing depending on dose level
Duration - Up to 2 years
After completing study treatment, participants are monitored for safety and cancer outcomes with visits every 3 months for up to 2 years.
Visits every 3 months for up to 2 years
Trial Site Locations
Total: 18 locations
1
Moffitt Cancer Center
Tampa, Florida, United States, 33612
Actively Recruiting
2
Northwestern University
Chicago, Illinois, United States, 60611
Actively Recruiting
3
University of Kansas Clinical Research Center
Fairway, Kansas, United States, 66205
Actively Recruiting
4
University of Kansas Cancer Center
Kansas City, Kansas, United States, 66160
Actively Recruiting
5
University of Kansas Hospital-Westwood Cancer Center
Westwood, Kansas, United States, 66205
Actively Recruiting
6
University of Kentucky/Markey Cancer Center
Lexington, Kentucky, United States, 40536
Active, Not Recruiting
7
University of Maryland/Greenebaum Cancer Center
Baltimore, Maryland, United States, 21201
Actively Recruiting
8
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08903
Actively Recruiting
9
Rutgers New Jersey Medical School
Newark, New Jersey, United States, 07101
Actively Recruiting
10
Montefiore Medical Center-Einstein Campus
The Bronx, New York, United States, 10461
Actively Recruiting
11
Montefiore Medical Center - Moses Campus
The Bronx, New York, United States, 10467
Actively Recruiting
12
Carolinas Medical Center/Levine Cancer Institute
Charlotte, North Carolina, United States, 28203
Active, Not Recruiting
13
Atrium Health Cabarrus/LCI-Concord
Concord, North Carolina, United States, 28025
Active, Not Recruiting
14
University of Cincinnati Cancer Center-UC Medical Center
Cincinnati, Ohio, United States, 45219
Actively Recruiting
15
University of Cincinnati Cancer Center-West Chester
West Chester, Ohio, United States, 45069
Actively Recruiting
16
University of Virginia Cancer Center
Charlottesville, Virginia, United States, 22908
Suspended
17
VCU Massey Comprehensive Cancer Center
Richmond, Virginia, United States, 23298
Actively Recruiting
18
University Health Network-Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Suspended
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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