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RECRUITING Phase 1

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

NCT05172245 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 46 participants
Start Date 2022-09-19
Est. Completion 2026-06-01
Phase Phase 1

Sponsor

National Cancer Institute (NCI)

2,390 total trials

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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. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 46 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 2,390 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05172245 reports 18 study locations spanning 11 distinct geographic areas — top geographies include Kansas, New Jersey, New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05172245?

This trial is sponsored by National Cancer Institute (NCI), which has 2,390 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial