Testing the Addition of Ipatasertib to Usual Chemotherapy and Radiation for Head and Neck Cancer
Recruiting
Phase 1
Interventional Study
Clinical Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8
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 Nasal Cavity Squamous Cell Carcinoma
Locally Advanced Oral Cavity Squamous Cell Carcinoma
Locally Advanced Oropharyngeal Squamous Cell Carcinoma
Locally Advanced Paranasal Sinus Squamous Cell Carcinoma
Locally Advanced Sinonasal Squamous Cell Carcinoma
Maxillary Sinus Squamous Cell Carcinoma
Stage III Hypopharyngeal Carcinoma AJCC v8
Stage III Laryngeal Cancer AJCC v8
Stage III Lip and Oral Cavity Cancer AJCC v8
Stage III Oropharyngeal (p16-Negative) Carcinoma AJCC v8
Stage III Sinonasal Cancer AJCC v8
Stage IVA Hypopharyngeal Carcinoma AJCC v8
Stage IVA Laryngeal Cancer AJCC v8
Stage IVA Lip and Oral Cavity Cancer AJCC v8
Stage IVA Oropharyngeal (p16-Negative) Carcinoma AJCC v8
Stage IVA Sinonasal Cancer AJCC v8
Stage IVB Hypopharyngeal Carcinoma AJCC v8
Stage IVB Laryngeal Cancer AJCC v8
Stage IVB Lip and Oral Cavity Cancer AJCC v8
Stage IVB Oropharyngeal (p16-Negative) Carcinoma AJCC v8
Stage IVB Sinonasal Cancer AJCC v8
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 1
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 46 (estimated)
- Sponsor
- National Cancer Institute (NCI) · NIH
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About This Trial
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 chemotherap…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* 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 an…
Contacts
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