Phase 1Recruiting

Comparing Biospecimen Collection with Biopsy Procedure for clinical stage II HPV-mediated (p16-positive) oropharyngeal

Official title: Testing the Addition of Ipatasertib to Usual Chemotherapy and Radiation for Head and Neck Cancer

Phase 1/1b Study of AKT Inhibitor Ipatasertib With Chemoradiation for Locally Advanced Head and Neck Cancer

Condition: Clinical Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8Sponsor: National Cancer Institute (NCI)Target enrollment: 46

Phase 1
2 groups
One site, in Toronto
Recruiting

Interventions (8)

Medical procedure
Biopsy Procedure
Undergo tumor biopsy
Medical procedure
Biospecimen Collection
Undergo blood sample collection
Medication
Cisplatin
Given IV
Medical procedure
Computed Tomography
Undergo CT or PET/CT
Medication
Ipatasertib
Given PO
Medical procedure
Magnetic Resonance Imaging
Undergo MRI
Medical procedure
Positron Emission Tomography
Undergo PET/CT
Radiation therapy
Radiation Therapy
Undergo radiation therapy

Canadian Sites (1)

1 listed, none recruiting

University Health Network-Princess Margaret Hospital
Toronto, Ontario
Paused

See who this study is looking for42 criteria

The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.

Inclusion

+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 Staging System, 8th or 9th edition (Ed.)
+Eastern Cooperative Oncology Group (ECOG) performance status 0-1
+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, accompanied by a negative HBV deoxyribonucleic acid \[DNA\] test) are eligible. Patients with chronic HBV infection are eligible if the HBV viral load is undetectable on suppressive therapy, if indicated. Patients undergoing current treatment with anti-viral therapy for HBV are ineligible
+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 are eligible if they have an undetectable HCV viral load
+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 for human papilloma virus (HPV), for example by p16 immunohistochemistry (IHC), in situ hybridization (ISH), or polymerase chain reaction (PCR). HPV testing is not required for other HNSCC primary tumor sites
+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.
+Able to swallow tablets at the time of enrollment
+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)
+Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
+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
+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 failure rate of \< 1% per year during the treatment period and for at least 28 days after the last dose of ipatasertib and agreement to refrain from donating eggs during this same period. For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm during the treatment period and for 28 days after the last dose of ipatasertib
+Must be candidate for concurrent, definitive cisplatin and radiation therapy as judged by the treating physician
+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

Exclusion

−History of allergic reactions attributed to compounds of similar chemical or biologic composition to ipatasertib or other agents used in study
−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 \[HCV\] antibody at screening), or cirrhosis
−Primary tumor of nasopharynx, salivary, thyroid or parathyroid glands, or skin
−Distant metastases from the current HNSCC
−Current use of any other investigational agents
−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 constantly changing, it is important to regularly consult a frequently-updated medical reference. As part of the enrollment/informed consent procedures, the patient will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the patient is considering a new over-the-counter medicine or herbal product
−Patients with uncontrolled intercurrent illness, including active infection
−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 medication \>= 4 weeks prior to initiation of study treatment. Patients with a history of diabetes mellitus, an abnormal fasting glucose level, or other signs or symptoms indicating diabetes mellitus, must meet the laboratory eligibility criteria for fasting blood glucose and hemoglobin A1c
−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 pneumonia)
−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)
−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 nursing infants secondary to treatment of the mother with ipatasertib, breastfeeding should be discontinued if the mother is treated with ipatasertib. These potential risks may also apply to other agents used in this study
−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 who underwent prior definitive surgery alone for an early stage (T1-2N0) HNSCC which has now recurred with stage III-IVB disease at least 3 months after the initial surgery are eligible
−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 neck or adjacent anatomical site for another malignancy, there may be no overlap with current area to be irradiated

5 concepts to explore on this page · up to 1,300 pointsTap any term to learn what it means.

In plain language

Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.

Learning

What this study is

This study is testing a treatment for a condition.

Phase 1 — an early safety study in a small group, checking how it is tolerated and at what dose.

From the trial registry

Built from these fields:

designModule.designInfo.primaryPurpose
designModule.phases

Who receives what

There are 2 groups in this study.

Group A receives Ipatasertib, Cisplatin and Radiation Therapy, together with one or more of: Biospecimen Collection, Computed Tomography, Magnetic Resonance Imaging and Positron Emission Tomography.

Registry label: A: Dose Escalation (ipatasertib, cisplatin, radiation therapy)

Group B receives Ipatasertib, Cisplatin and Radiation Therapy, together with one or more of: Biopsy Procedure, Biospecimen Collection, Computed Tomography, Magnetic Resonance Imaging and Positron Emission Tomography.

Registry label: B: Dose Expansion (ipatasertib, cisplatin, radiation therapy)

From the trial registry

Built from these fields:

armsInterventionsModule.armGroups[].label
armsInterventionsModule.armGroups[].type
armsInterventionsModule.armGroups[].interventionNames

How the study is run

This study is open-label: everyone knows which treatment is being given, including you and the study team.

From the trial registry

Built from this field:

designModule.designInfo.maskingInfo.masking

Is there a placebo?

This study does not list a placebo group.

From the trial registry

Built from these fields:

armsInterventionsModule.armGroups[].type
armsInterventionsModule.armGroups[].interventionNames

Who the study is looking for

The study lists a minimum age of 18 years, with no upper limit given.

The study is open to people of any sex.

The study does not accept healthy volunteers.

These are the criteria the study lists. Only the trial site can decide whether someone can take part.

From the trial registry

Built from these fields:

eligibilityModule.minimumAge
eligibilityModule.sex
eligibilityModule.healthyVolunteers

How big and how long

The study aims to enrol about 46 people.

The study is currently expected to finish around July 2027.

The main measurement is taken over: At the completion of dose escalation phase, up to 56 days from treatment start date.

From the trial registry

Built from these fields:

designModule.enrollmentInfo.count
statusModule.completionDateStruct.date
outcomesModule.primaryOutcomes[].timeFrame

What the study measures

Maximum tolerated dose (MTD) and recommended phase 2 dose of ipatasertib in combination with definitive chemo-radiation — measured over At the completion of dose escalation phase, up to 56 days from treatment start date.

From the trial registry

Built from these fields:

outcomesModule.primaryOutcomes[].measure
outcomesModule.primaryOutcomes[].timeFrame

Source: NCT05172245 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.

Not medical advice. What do these terms mean?