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

Objective

To determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of ipatasertib in combination with definitive chemoradiation in locally advanced head and neck squamous cell carcinoma (HNSCC) based on dose-limiting toxicities (DLTs).

Protocol #

NCI-10492

Trial Phase:

Phase I

Principal Investigator:

Alesi, Erin

Cancer Type
  • Larynx
  • Lip
  • Oral Cavity and Pharynx
Study Site
  • Virginia Commonwealth University

- Patients must have pathologically confirmed HNSCC (including tumors of the oropharynx, hypopharynx, larynx, oral cavity, nasal cavity, maxillary and other paranasal sinuses, and unknown primary of the head and neck), with measurable disease as per RECIST 1.1
- Oropharyngeal and unknown primary squamous cell cancers must test negative for human papilloma virus (HPV), for example by p16 IHC, ISH, or PCR, regardless of AJCC/TNM stage. HPV testing is not required for other HNSCC primary tumor sites
- Clinical stage III-IVB (locally advanced but non-metastatic) according to the American Joint Committee on Cancer
- Must be candidate for concurrent, definitive cisplatin and radiation therapy as judged by the treating physician
- Able to swallow tablets at the time of enrollment
- Age >/=18 years
- Life expectancy of greater than 3 months

Get more detailed information at ClinicalTrials.gov

  • Enrollment Status 1
  • Age Group Adult
  • Protocol Type Treatment
  • Research Study Team Carrie Donovan, RN
    Phone: +1 804-628-3836
    Email Study Contact

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