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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.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up two months

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

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

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

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

+8 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%

Platelet count decreased

14%

Dry mouth

14%

Weight decreased

14%

Dysgeusia

13%

Dyspnoea

12%

Abdominal pain upper

12%

Back pain

12%

Dizziness

11%

Pyrexia

11%

Dyspepsia

11%

Oedema peripheral

11%

Blood creatinine increased

10%

Pain

Stomatitis

Aspartate aminotransferase increased

Dry skin

Thrombocytopenia

Pruritus

Lacrimation increased

Dehydration

Alanine aminotransferase increased

Flatulence

Urinary tract infection

Upper respiratory tract infection

Hypokalaemia

Chills

Musculoskeletal chest pain

Musculoskeletal pain

Anxiety

Rash

Gastrooesophageal reflux disease

Myalgia

Cellulitis

Pleural effusion

Atypical pneumonia

Gastroenteritis viral

Sepsis

Hip fracture

Pneumonitis

Fall

Lung infection

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

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

~1710

0 / 17Eligibility criteria met