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New treatment option for Clinical Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma...
Official title Testing the Addition of Ipatasertib to Usual Chemotherapy and Radiation for Head and Neck Cancer
ClinicalTrials.gov ID: NCT05172245
What this study is testing
What is Cisplatin?
Cisplatin is an investigational medicine, given as an once-weekly infusion into a vein, being studied as a potential treatment for clinical stage ii hpv-mediated (p16-positive) oropharyngeal carcinoma ajcc v8.
Also referred to as Abiplatin, Blastolem.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- Time commitment: about 2 years
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patients must have pathologically confirmed HNSCC (including tumors of the oropharynx, hypopharynx, larynx, oral cavity, nasal cavity, maxillary and...
- Oropharyngeal and unknown primary squamous cell cancers must test for human papilloma virus (HPV), for example by p16 immunohistochemistry (IHC), in...
- Patients with p16-positive tumors are eligible if M0 and any of one the following: cT4 or cN3 or cT2-3N2 or imaging-detected extranodal extension...
- Patients with p16-negative (or not tested) tumors are eligible if clinical stage III-IVB (locally advanced but non-metastatic) according to the...
- Must be candidate for concurrent, definitive cisplatin and radiation therapy as judged by the treating physician
You likely can't join if
- Primary tumor of nasopharynx, salivary, thyroid or parathyroid glands, or skin
- Distant metastases from the current HNSCC
- Prior treatment (e.g., chemotherapy, radiation, or definitive surgery) for the current locally advanced HNSCC is not permitted. Biopsies, including...
- For patients with a prior history of another malignancy, no prior chemotherapy or radiation may have been administered within 6 weeks prior to study...
- Current use of any other investigational agents
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to ipatasertib or other agents used in study
See the full eligibility criteria
Who can join
- 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)...
- Oropharyngeal and unknown primary squamous cell cancers must test for human papilloma virus (HPV), for example by p16 immunohistochemistry (IHC), in situ hybridization (ISH), or polymerase chain reaction (PCR). HPV...
- Patients with p16-positive tumors are eligible if M0 and any of one the following: cT4 or cN3 or cT2-3N2 or imaging-detected extranodal extension (iENE) according to the American Joint Committee on Cancer (AJCC)/TNM...
- Patients with p16-negative (or not tested) tumors are eligible if clinical stage III-IVB (locally advanced but non-metastatic) according to the AJCC/TNM Staging System, 8th or 9th Ed.
- 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. Because no dosing or adverse event data are currently available on the use of ipatasertib in combination with chemoradiation in patients \< 18 years of age, children are excluded from this study
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Life expectancy of greater than 3 months
- Absolute neutrophil count \>= 3000/mcL
- Hemoglobin \>= 10 g/dL
- Platelets \>= 150,000/mcL
- Serum albumin \>= 3 g/dL
- Total bilirubin =\< 1.5 x institutional upper limit of normal (ULN)
- Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =\< 2.5 x institutional ULN / 2 x institutional ULN
- Alkaline phosphatase (ALP) =\< 2.0 x institutional ULN
- Partial thromboplastin time (PTT) (or activated [a]PTT) and international normalized ratio (INR) =\< 1.5 institutional ULN (except for patients receiving anticoagulation therapy)
- Creatinine clearance (CLcr) \> 60 mL/min
- For this calculation, use the Cockroft-Gault formula
- Fasting glucose =\< 150 mg/dL (8.3 mmol/L) and (when indicated) glycosylated hemoglobin (HbA1c ) =\< 7.5% (58 mmol/mol)
- Human immunodeficiency virus (HIV)-infected patients are eligible if on effective anti-retroviral therapy with undetectable viral load within 6 months
- Patients with past hepatitis B virus (HBV) infection or resolved HBV infection (defined as having a negative hepatitis B virus surface antigen [HBsAg] test and a positive hepatitis B core antibody [HBcAb] test...
- Patients with a history of hepatitis C virus (HCV) infection are eligible only if polymerase chain reaction (PCR) is negative for HCV ribonucleic acid (RNA). Patients with HCV infection who are currently on treatment...
- Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or how well it works assessment of the investigational regimen are eligible for...
- The effects of ipatasertib on the developing human fetus are unknown. For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods with a...
- Ability to understand and the willingness to sign a written informed consent document
- For the expansion cohort only, there is a mandatory ask of patients to consider undergoing on-treatment biopsies
What rules you out
- Primary tumor of nasopharynx, salivary, thyroid or parathyroid glands, or skin
- Distant metastases from the current HNSCC
- Prior treatment (e.g., chemotherapy, radiation, or definitive surgery) for the current locally advanced HNSCC is not permitted. Biopsies, including those performed under anesthesia, are not considered surgery. Patients...
- For patients with a prior history of another malignancy, no prior chemotherapy or radiation may have been administered within 6 weeks prior to study entry. Among patients who received prior radiation to the head and...
- Current use of any other investigational agents
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to ipatasertib or other agents used in study
- Treatment with strong inhibitors or inducers of CYP3A4 or P-glycoprotein within 2 weeks or 5 drug-elimination half-lives, whichever is longer, prior to initiation of study drug. Because the lists of these agents are...
- Patients with uncontrolled intercurrent illness, including active infection
- Pregnant women are excluded from this study because ipatasertib is an oral AKT inhibitor with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in...
- Patients with type I or type II diabetes mellitus requiring insulin at study entry. Patients with non-insulin dependent type II diabetes mellitus are eligible, as are patients who are on a stable dose of oral diabetes...
- History of or active inflammatory bowel disease (e.g., Crohn's disease and ulcerative colitis) or active bowel inflammation (e.g., diverticulitis)
- History of malabsorption syndrome or other condition that would interfere with enteral absorption or results in the inability or unwillingness to swallow pills
- Lung disease: pneumonitis, interstitial lung disease, idiopathic pulmonary fibrosis, cystic fibrosis, aspergillosis, active tuberculosis, or history of opportunistic infections (pneumocystis pneumonia or cytomegalovirus...
- Known clinically significant history of liver disease consistent with Child Pugh Class B or C, including active viral or other hepatitis (e.g., positive for hepatitis B surface antigen [HBsAg] or hepatitis C virus [HCV]...
- Grade \>= 2 uncontrolled or untreated hypercholesterolemia (cholesterol \> 300 mg/dL or \> 7.75 mmol/L) or hypertriglyceridemia (triglycerides \> 300 mg/dL or \> 3.42 mmol/L)
The study team makes the final eligibility decision.
Where it's taking place
- Tampa, Florida, United States
- Chicago, Illinois, United States
- Fairway, Kansas, United States
- Kansas City, Kansas, United States
- Westwood, Kansas, United States
- Lexington, Kentucky, United States
- Baltimore, Maryland, United States
- New Brunswick, New Jersey, United States
- Newark, New Jersey, United States
- The Bronx, New York, United States
- Charlotte, North Carolina, United States
- Concord, North Carolina, United States
- Cincinnati, Ohio, United States
- West Chester, Ohio, United States
- Charlottesville, Virginia, United States
- Richmond, Virginia, United States
- Toronto, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 2 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tampa, Florida, United States; Chicago, Illinois, United States; Fairway, Kansas, United States; Kansas City, Kansas, United States; Westwood, Kansas, United States; Lexington, Kentucky, United States and 11 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.