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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 belowSelect...
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.
Select...
My kidney function is normal, with creatinine levels within the acceptable range.
Select...
I have two primary tumors or tumors in both sides of a body part.
Select...
My kidney function is within normal limits.
Select...
I have been diagnosed with a specific type of throat or mouth cancer that is p16-negative.
Select...
I have not received any treatment for my head and neck cancer.
Select...
I can take pills by mouth.
Select...
My blood counts meet the required levels for treatment.
Select...
I am scheduled for surgery to remove my cancer and possibly affected lymph nodes.
Select...
I have two primary tumors or tumors in both sides of a body part.
Select...
My cancer can be measured by scans or physical tools.
Select...
I have been diagnosed with a specific type of throat or mouth cancer that is p16-negative.
Select...
I am fully active or can carry out light work.
Select...
I am fully active or can carry out light work.
Select...
I am scheduled for surgery to remove my cancer and possibly affected lymph nodes.
Select...
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
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 moreSide effects data
From 2018 Phase 2 trial • 132 Patients • NCT0210249091%
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
9%
Stomatitis
9%
Aspartate aminotransferase increased
8%
Dry skin
8%
Thrombocytopenia
8%
Pruritus
8%
Lacrimation increased
8%
Dehydration
8%
Alanine aminotransferase increased
7%
Flatulence
7%
Urinary tract infection
7%
Upper respiratory tract infection
7%
Hypokalaemia
6%
Chills
6%
Musculoskeletal chest pain
6%
Musculoskeletal pain
6%
Anxiety
5%
Rash
5%
Gastrooesophageal reflux disease
5%
Myalgia
2%
Cellulitis
2%
Pleural effusion
1%
Atypical pneumonia
1%
Gastroenteritis viral
1%
Sepsis
1%
Hip fracture
1%
Pneumonitis
1%
Fall
1%
Lung infection
1%
Pneumothorax
1%
Febrile neutropenia
1%
Respiratory tract infection
1%
Haematotoxicity
1%
Sinus bradycardia
1%
Tachycardia
1%
Large intestinal obstruction
1%
Pancreatic enzyme abnormality
1%
Pancreatitis
1%
Varices oesophageal
1%
Electrocardiogram abnormal
1%
Liver function test abnormal
1%
Renal function test abnormal
1%
Bone pain
1%
Muscular weakness
1%
Acute kidney injury
1%
Pulmonary embolism
1%
Arterial thrombosis
1%
Epilepsy
100%
80%
60%
40%
20%
0%
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 15-21 days (+7 days). Abemaciclib will be administered from days 1-21 in both arms. Abemaciclib may be continued for an additional 7 days, or up to 28 days, for delays in planned surgery. Abemaciclib 150 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
Find a Location
Who is running the clinical trial?
University of ArizonaLead Sponsor
514 Previous Clinical Trials
148,574 Total Patients Enrolled
George Washington UniversityOTHER
243 Previous Clinical Trials
453,754 Total Patients Enrolled
Julie Bauman, MD, MPHPrincipal InvestigatorUniversity of Arizona
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer can be measured by scans or physical tools.I have not received any treatment for my head and neck cancer.You agree to provide tissue samples for research purposes, including a biopsy of the tumor before and during surgery.My tumor is not caused by HPV.My kidney function is normal, with creatinine levels within the acceptable range.I have two primary tumors or tumors in both sides of a body part.My second head/neck cancer is treated, 1cm away from the first, and no recurrence in 2 years.My kidney function is within normal limits.I have not taken any CDK 4/6 or PD-1/L1 inhibitors.I have been diagnosed with a specific type of throat or mouth cancer that is p16-negative.I have not received any treatment for my head and neck cancer.I can take pills by mouth.My cancer is between stage I and IVa according to AJCC.My blood counts meet the required levels for treatment.I am scheduled for surgery to remove my cancer and possibly affected lymph nodes.I have two primary tumors or tumors in both sides of a body part.I will use effective birth control during and after the study as required.My cancer can be measured by scans or physical tools.My second head/neck cancer is treated, 1cm away from the first, and 2 years clear.My cancer is classified between stage I and IVa.I have been diagnosed with a specific type of throat or mouth cancer that is p16-negative.I am fully active or can carry out light work.My tumor is not caused by HPV.My liver functions are within the required range.I am fully active or can carry out light work.I am scheduled for surgery to remove my cancer and possibly affected lymph nodes.I can take pills by mouth.I haven't taken strong immune system drugs in the last 14 days, except for minor exceptions like creams or low-dose steroids.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment with abemaciclib
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are we able to enroll new participants in this clinical trial at this time?
"The latest information from clinicaltrials.gov shows that this study is actively recruiting patients. This trial was first posted on June 16th, 2021 and updated as recently as March 3rd, 2022."
Answered by AI
For what purpose is Abemaciclib typically prescribed?
"Abemaciclib is most commonly used to prevent cancer relapse. It can also be taken to treat various conditions including advanced hr+ her2- breast cancer, endocrine therapy, and breast cancer."
Answered by AI
Has the US Food and Drug Administration given Abemaciclib their seal of approval?
"Abemaciclib's safety was rated a 2 by our team. This is because, while there is data supporting its safety profile, none of the clinical trials conducted thus far have looked at whether or not it is an effective medication."
Answered by AI
What are the goals of this research project?
"The primary focus of this trial, which will last for a period of two months, is to measure the quantitative change in tumor size to gain an understanding of abemaciclib's clinical activity. Additionally, this study hopes to describe how oral and intestinal microbiomes are associated with the clinical activity of abemaciclib (with or without nivolumab) as well as understand how serum Th1 and Th2 cytokine profiles are altered by abemaciclib (with or without nivolumab). Finally, another goal is to measure the distribution of peripheral immune cell subtypes and their activation status before and"
Answered by AI
Will this clinical trial offer scientists new insights?
"Abemaciclib is being trialed in 97 different ongoing studies located in 41 countries and 1276 cities. The first trial, sponsored by Eli Lilly and Company, took place in 2009 with 220 patients. It completed its Phase 1 drug approval stage. In the years since then, 30 more trials have been completed."
Answered by AI
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