Phase 1 Head and Neck Cancer Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who have been diagnosed with a confirmed squamous cell cancer of the head and neck (including cancers of the throat, voice box, mouth, nasal cavity, sinuses, or an unknown primary site in the head and neck), with disease that can be measured on scans according to standard criteria.
• People with throat (oropharyngeal) cancer or unknown primary head and neck cancer that has been tested for the human papillomavirus (HPV), using standard laboratory methods.
• People with HPV-positive (p16-positive) tumours that have not spread to distant parts of the body, and meet certain staging criteria for tumour or lymph node involvement (confirm with trial site).
• People with HPV-negative (or untested) tumours that are at a locally advanced but non-metastatic stage (Stage III–IVB) according to standard cancer staging guidelines.
• People whose treating doctor considers them suitable for treatment with cisplatin (chemotherapy) and radiation therapy given at the same time.
• People who are able to swallow tablets at the time of joining the trial.
• People aged 18 years or older.
• People with a good general level of physical functioning, rated 0 or 1 on a standard performance scale (confirm with trial site).
• People with a life expectancy of more than 3 months.
• People whose blood test results meet the required levels for white blood cells, red blood cells, platelets, albumin, liver function, kidney function, and blood clotting (confirm specific values with trial site).
• People with a fasting blood sugar level at or below 150 mg/dL, and, where relevant, a HbA1c (a measure of longer-term blood sugar control) at or below 7.5%.
• People living with HIV, provided they are on effective treatment and have had an undetectable viral load within the past 6 months.
• People with a past or resolved hepatitis B infection, provided specific test results meet the required criteria (confirm with trial site).
• People with a history of hepatitis C infection, provided the virus is no longer detectable in the blood.
• People who have or have had another cancer, provided that cancer or its treatment is not expected to interfere with this trial's safety or results assessment.
• People who agree to use highly effective contraception or remain abstinent during treatment and for at least 28 days after the last dose of the study drug, and agree not to donate eggs or sperm during this period.
• People who are willing and able to understand and sign a written informed consent form.
• People joining the expansion part of the trial who are willing to consider having a tissue biopsy taken during treatment.

Who may not be able to join:

• People whose cancer started in the nasopharynx, salivary glands, thyroid, parathyroid glands, or skin.
• People whose head and neck cancer has spread to distant parts of the body (distant metastases).
• People who have already received chemotherapy, radiation, or definitive surgery for their current locally advanced head and neck cancer (note: diagnostic biopsies are not considered surgery).
• People who received chemotherapy or radiation for a previous different cancer within 6 weeks before joining the trial, or whose previous head and neck radiation would overlap with the area to be treated in this trial.
• People currently taking part in another clinical trial involving an investigational treatment.
• People with a known history of allergic reactions to ipatasertib or to other drugs with a similar chemical makeup to those used in this trial.
• People who have taken certain medications that strongly affect the way the body processes the study drug (known as strong CYP3A4 or P-glycoprotein inhibitors or inducers) within 2 weeks or 5 drug-elimination half-lives before starting the study drug, whichever is longer (confirm with trial site).
• People with an uncontrolled ongoing illness, including an active infection.
• People who are pregnant or breastfeeding.
• People with type 1 diabetes or type 2 diabetes requiring insulin at the time of joining; however, people with type 2 diabetes managed with stable oral medication for at least 4 weeks may be eligible (confirm with trial site).
• People with a history of, or currently active, inflammatory bowel disease (such as Crohn's disease or ulcerative colitis) or active bowel inflammation such as diverticulitis.
• People with a condition that affects the body's ability to absorb food or medication through the digestive system, or who are unable or unwilling to swallow pills.
• People with certain lung conditions, including pneumonitis, interstitial lung disease, pulmonary fibrosis, cystic fibrosis, aspergillosis, active tuberculosis, or a history of specific opportunistic lung infections.
• People with a known significant liver disease, including active hepatitis B or C, or cirrhosis, consistent with a moderate-to-severe liver impairment rating (Child Pugh Class B or C).
• People with uncontrolled or untreated high cholesterol (above 300 mg/dL) or high triglycerides (above 300 mg/dL) at a moderate or severe level.

Important: Always verify eligibility with the trial site directly before applying.