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NCT05172245 · ClinicalTrials.gov registry record · Phase 1
Testing the Addition of Ipatasertib to Usual Chemotherapy and Radiation for Head and Neck Cancer
A Phase 1 study of Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 and Head and Neck Carcinoma of Unknown Primary, sponsored by National Cancer Institute (NCI).
- Recruiting
- Registry status
- Phase 1
- Development phase
- 46
- Enrollment target
- 18
- Study locations
NCT05172245 is a Phase 1 study of Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 and Head and Neck Carcinoma of Unknown Primary that is actively recruiting participants, run by National Cancer Institute (NCI). The registered enrollment target is 46 participants, below the 219-participant average among 12 other Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 trials with a reported enrollment target (79% lower). The trial reports 18 study locations across 11 states.
The verdict
NCT05172245, a Phase 1 study of Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 and Head and Neck Carcinoma of Unknown Primary, is actively recruiting participants, sponsored by National Cancer Institute (NCI).
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 46 participants
- Enrollment target
- 18
- Study locations
Study 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.
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Computed Tomography
- DRUG Ipatasertib
- DRUG Cisplatin
- PROCEDURE Biopsy Procedure
Study Locations (18)
Kansas
- University of Kansas Clinical Research Center - Fairway
- University of Kansas Cancer Center - Kansas City
- University of Kansas Hospital-Westwood Cancer Center - Westwood
New Jersey
- Rutgers Cancer Institute of New Jersey - New Brunswick
- Rutgers New Jersey Medical School - Newark
New York
- Montefiore Medical Center-Einstein Campus - The Bronx
- Montefiore Medical Center - Moses Campus - The Bronx
North Carolina
- Carolinas Medical Center/Levine Cancer Institute - Charlotte
- Atrium Health Cabarrus/LCI-Concord - Concord
Ohio
- University of Cincinnati Cancer Center-UC Medical Center - Cincinnati
- University of Cincinnati Cancer Center-West Chester - West Chester
Virginia
- University of Virginia Cancer Center - Charlottesville
- VCU Massey Comprehensive Cancer Center - Richmond
Florida
- Moffitt Cancer Center - Tampa
Illinois
- Northwestern University - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 46 participants |
| Start Date | 2022-09-19 |
| Est. Completion | 2026-06-01 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05172245
The ClinicalTrials.gov registry entry for NCT05172245 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 46 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 219-participant average among 12 other Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 trials with a reported enrollment target (79% lower). The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 10 conditions, with Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT05172245 reports 18 study locations spanning 11 distinct geographic areas - top geographies include Kansas, New Jersey, New York.
Frequently Asked Questions
What is clinical trial NCT05172245 about?
NCT05172245 is a clinical study titled "Testing the Addition of Ipatasertib to Usual Chemotherapy and Radiation for Head and Neck Cancer". 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) in...
What is the current status of trial NCT05172245?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 46 participants. The study started on 2022-09-19. Estimated completion is 2026-06-01.
What conditions does trial NCT05172245 study?
This clinical trial studies the following conditions: Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, Head and Neck Carcinoma of Unknown Primary, Locally Advanced Head and Neck Squamous Cell Carcinoma, Locally Advanced Hypopharyngeal Squamous Cell Carcinoma, Locally Advanced Laryngeal Squamous Cell Carcinoma.
What interventions are being tested in trial NCT05172245?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Ipatasertib (DRUG), Cisplatin (DRUG), Biopsy Procedure (PROCEDURE).
Who is sponsoring clinical trial NCT05172245?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05172245 being conducted?
This trial has 18 study locations across Florida, Illinois, Kansas, Kentucky, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8
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