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Abemaciclib for Head and Neck Cancer

Phase 2

Recruiting

Led By Julie Bauman, MD, MPH

Research Sponsored by University of Arizona

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Clinically or radiologically measurable disease; the primary tumor and/or cervical nodes may be measurable according to RECIST 1.1 (tumor diameter ≥ 1 cm; short-axis lymph node diameter ≥ 1.5 cm) OR by caliper/ruler measurement (tumor diameter ≥ 1 cm).

No prior treatment for the index (study-qualifying) HNSCC.

Must not have

Patient has a personal history of any of the following cardiac or pulmonary abnormalities: Syncope of cardiovascular etiology Ventricular arrhythmia of pathologic origin (including, but limited to, ventricular tachycardia and ventricular fibrillation) Sudden cardiac arrest Documented history of New York Heart Association functional classification III-IV congestive heart failure Myocardial infarction ≤ 6 months prior to enrollment Current unstable angina pectoris Interstitial lung disease Severe dyspnea at rest or requiring oxygen therapy Patient with impaired gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral abemaciclib (e.g. history of major surgical resection involving the stomach or small bowel, malabsorption syndrome, preexisting Crohn's disease or ulcerative colitis, preexisting chronic condition resulting in baseline Grade 2 or higher diarrhea). Patients who require the chronic administration of drugs that are strong and moderate inducers of Cytochrome P450, family 3, subfamily A, (CYP3A) and/or strong inhibitors of CYP3A, and no acceptable substitute can be identified, are not eligible for study (See Appendix 2). Such drugs should be discontinued at least 7 days before the start of study treatment. The patient has active bacterial infection (requiring intravenous [IV] antibiotics at time of initiating study treatment), fungal infection, or detectable viral infection (such as known human immunodeficiency virus positivity or known active hepatitis B or C [e.g. hepatitis B surface antigen positive or hepatitis C antibody positive with detectable viral load]). Screening for HIV or hepatitis is not required for enrollment. Patient with any other condition that would, in the Investigator's judgment, preclude patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures, e.g. social/psychological complications. Pregnant or nursing (lactating) women

Prior treatment with any cyclin-dependent kinase (CDK) 4/6 inhibitor or anti-programmed death (PD)-1/L1 inhibitor is not allowed

Timeline

Screening 3 weeks

Treatment Varies

Follow Up two months

Awards & highlights

No Placebo-Only Group

Summary

This trial will assess the effects of the drug abemaciclib on patients with head and neck squamous cell carcinoma who do not have the HPV virus.

Who is the study for?

This trial is for adults with HPV-negative head and neck squamous cell carcinoma (HNSCC) who have not been treated before. They must be physically well enough to participate, able to swallow pills, and have no serious heart or lung conditions. Patients with certain previous cancers can join if they've been cancer-free for 2 years. Women of childbearing potential must use effective contraception.

What is being tested?

The AIM Trial is testing the effects of a drug called Abemaciclib in patients with specific types of HNSCC that are HPV-negative. It's an open label Phase II trial where all participants receive the drug before their planned surgery to remove the tumor.

What are the potential side effects?

Abemaciclib may cause side effects like diarrhea, fatigue, low blood cell counts which can increase infection risk, liver problems, deep vein thrombosis or pulmonary embolism (blood clots), and possibly harm an unborn baby if taken during pregnancy.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer can be measured by scans or physical tools.

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I have not received any treatment for my head and neck cancer.

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My kidney function is normal, with creatinine levels within the acceptable range.

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I have two primary tumors or tumors in both sides of a body part.

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My kidney function is within normal limits.

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I have been diagnosed with a specific type of throat or mouth cancer that is p16-negative.

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I have not received any treatment for my head and neck cancer.

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I can take pills by mouth.

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My blood counts meet the required levels for treatment.

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I am scheduled for surgery to remove my cancer and possibly affected lymph nodes.

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I have two primary tumors or tumors in both sides of a body part.

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My cancer can be measured by scans or physical tools.

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I have been diagnosed with a specific type of throat or mouth cancer that is p16-negative.

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I am fully active or can carry out light work.

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I am fully active or can carry out light work.

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I am scheduled for surgery to remove my cancer and possibly affected lymph nodes.

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I can take pills by mouth.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have not taken any CDK 4/6 or PD-1/L1 inhibitors.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ two months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~two months

This trial's timeline: 3 weeks for screening, Varies for treatment, and two months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Measure quantitative change in tumor size to assess the clinical activity of abemaciclib.

Secondary study objectives

Describe the safety and tolerability of neoadjuvant exposure to abemaciclib in accordance with NCI Common Terminology Criteria for Adverse Events (CTCAE) v.5.

Other study objectives

Describe features of the oral and intestinal microbiomes that are associated with the clinical activity of abemaciclib.

Measure Interferon gamma (IFN-ɣ) gene expression signature in baseline and post-treatment tumor biopsies.

Measure change in the proliferative index (∆Ki67) in pre- and post-treatment tumor specimens.

+7 more

Side effects data

From 2018 Phase 2 trial • 132 Patients • NCT02102490

91%

Diarrhoea

67%

Nausea

48%

Fatigue

45%

Decreased appetite

35%

Vomiting

27%

Anaemia

26%

Abdominal pain

23%

Asthenia

23%

Neutrophil count decreased

21%

Cough

20%

Constipation

20%

Headache

19%

Arthralgia

18%

White blood cell count decreased

18%

Neutropenia

15%

Alopecia

14%

Dry mouth

14%

Platelet count decreased

14%

Weight decreased

14%

Dysgeusia

13%

Dyspnoea

12%

Abdominal pain upper

12%

Back pain

12%

Dizziness

11%

Oedema peripheral

11%

Dyspepsia

11%

Pyrexia

11%

Blood creatinine increased

10%

Pain

Stomatitis

Aspartate aminotransferase increased

Thrombocytopenia

Lacrimation increased

Dehydration

Dry skin

Pruritus

Alanine aminotransferase increased

Flatulence

Upper respiratory tract infection

Urinary tract infection

Hypokalaemia

Chills

Musculoskeletal chest pain

Musculoskeletal pain

Anxiety

Gastrooesophageal reflux disease

Rash

Myalgia

Cellulitis

Pleural effusion

Atypical pneumonia

Gastroenteritis viral

Lung infection

Sepsis

Fall

Hip fracture

Pneumonitis

Pneumothorax

Febrile neutropenia

Respiratory tract infection

Haematotoxicity

Sinus bradycardia

Tachycardia

Large intestinal obstruction

Pancreatic enzyme abnormality

Pancreatitis

Varices oesophageal

Electrocardiogram abnormal

Liver function test abnormal

Renal function test abnormal

Bone pain

Muscular weakness

Acute kidney injury

Pulmonary embolism

Arterial thrombosis

Epilepsy

100%

80%

60%

40%

20%

Study treatment Arm

Abemaciclib

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment with abemaciclibExperimental Treatment1 Intervention

Treatment will consist of a single neoadjuvant cycle of 10-21 days (+7 days if needed due to surgical delay). Abemaciclib will be administered from days 1-21. Abemaciclib may be continued for an additional 7 days, or up to 28 days, for delays in planned surgery. Abemaciclib 200 mg PO twice daily on Days 1-21 (+7 days).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Abemaciclib

2019

Completed Phase 2

~1890

0 / 19Eligibility criteria met