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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: Recruiting 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).

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. According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

Patients who receive at least 70% of the prescribed course of ipatasertib on radiation days will be evaluable for dose limiting toxicity assessment. After the escalation phase of the trial is completed, the MTD will be selected using the pooled-adjacent-violators algorithm, a type of isotonic regression, as specified in Liu and Yuan (2015).

Conditions Studied

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 Locally Advanced Oropharyngeal Squamous Cell Carcinoma Locally Advanced Nasal Cavity Squamous Cell Carcinoma Locally Advanced Oral Cavity Squamous Cell Carcinoma Locally Advanced Paranasal Sinus Squamous Cell Carcinoma Locally Advanced Sinonasal Squamous Cell Carcinoma

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
National Cancer Institute (NCI)

3,257 total trials

What NCT05172245 shows while recruiting

NCT05172245 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 46 participants, a relatively small participant target, 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 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 lists 18 locations in 11 states (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.

Learn More About Clinical Trials

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Where NCT05172245's enrollment target sits among peer trials

46 9th of 12 higher than 4 of 12 other Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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More recruiting context for NCT05172245

Source: ClinicalTrials.gov NCT05172245, the US trial registry maintained by the National Library of Medicine. NCT05172245 (small enrollment · multi site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.