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Abemaciclib for Head and Neck Squamous Cell Carcinoma

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
University of Arizona, Tucson, AZHead and Neck Squamous Cell CarcinomaAbemaciclib - Drug
Eligibility
Any Age
All Sexes
What conditions do you have?
Select

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.

Eligible Conditions
  • Head and Neck Squamous Cell Carcinoma

Treatment Effectiveness

Effectiveness Progress

1 of 3

Similar Trials

1
TG4050
1
Intratumoral Ipilimumab
1
VX15/2503

Study Objectives

2 Primary · 14 Secondary · Reporting Duration: Two months

Two months
Describe features of the oral and intestinal microbiomes that are associated with the clinical activity of abemaciclib, with or without nivolumab
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.
Describe the safety and tolerability of neoadjuvant exposure to abemaciclib, with or without nivolumab, 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.
Measure change in the proliferative index (∆Ki67) in pre- and post-treatment tumor specimens.
Measure how serum Th1 and Th2 cytokine profiles are altered by abemaciclib, with or without nivolumab.
Measure how serum Th1 and Th2 cytokine profiles are altered by abemaciclib.
Neoplasms
Measure quantitative change in tumor size to assess the clinical activity of abemaciclib.
Measure the distribution of peripheral immune cell subtypes and their activation status
Measure the distribution of tumor-infiltrating immune cell subtypes and their activation status, as measured by flow cytometry.
Measure the distribution of tumor-infiltrating immune cell subtypes and their activation status, as measured by immunohistochemistry (IHC).
Measure the distribution of tumor-infiltrating immune cell subtypes and their activation status, as measured by nanostring.
Measure tumor-intrinsic genetic biomarkers utilizing tumor specimen.
Measure tumor-intrinsic molecular mediators of response and resistance to abemaciclib.

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Similar Trials

1
TG4050
1
Intratumoral Ipilimumab
1
VX15/2503

Side Effects for

Abemaciclib
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%Dysgeusia
14%Platelet count decreased
14%Dry mouth
14%Weight decreased
13%Dyspnoea
12%Abdominal pain upper
12%Back pain
12%Dizziness
11%Pyrexia
11%Blood creatinine increased
11%Oedema peripheral
11%Dyspepsia
10%Pain
9%Stomatitis
9%Aspartate aminotransferase increased
8%Thrombocytopenia
8%Lacrimation increased
8%Pruritus
8%Dry skin
8%Dehydration
8%Alanine aminotransferase increased
7%Upper respiratory tract infection
7%Flatulence
7%Urinary tract infection
7%Hypokalaemia
6%Musculoskeletal pain
6%Chills
6%Musculoskeletal chest pain
6%Anxiety
5%Myalgia
5%Gastrooesophageal reflux disease
5%Rash
2%Cellulitis
2%Pleural effusion
1%Large intestinal obstruction
1%Lung infection
1%Pneumothorax
1%Arterial thrombosis
1%Sinus bradycardia
1%Sepsis
1%Hip fracture
1%Respiratory tract infection
1%Renal function test abnormal
1%Liver function test abnormal
1%Fall
1%Pulmonary embolism
1%Gastroenteritis viral
1%Tachycardia
1%Haematotoxicity
1%Pancreatitis
1%Varices oesophageal
1%Electrocardiogram abnormal
1%Muscular weakness
1%Bone pain
1%Acute kidney injury
1%Febrile neutropenia
1%Pancreatic enzyme abnormality
1%Atypical pneumonia
1%Pneumonitis
1%Epilepsy
This histogram enumerates side effects from a completed 2018 Phase 2 trial (NCT02102490) in the Abemaciclib ARM group. Side effects include: Diarrhoea with 91%, Nausea with 67%, Fatigue with 48%, Decreased appetite with 45%, Vomiting with 35%.

Trial Design

1 Treatment Group

Treatment with abemaciclib
1 of 1

Experimental Treatment

20 Total Participants · 1 Treatment Group

Primary Treatment: Abemaciclib · No Placebo Group · Phase 2

Treatment with abemaciclib
Drug
Experimental Group · 1 Intervention: Abemaciclib · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Abemaciclib
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: two months

Who is running the clinical trial?

University of ArizonaLead Sponsor
469 Previous Clinical Trials
153,312 Total Patients Enrolled
Julie Bauman, MD, MPHPrincipal InvestigatorUniversity of Arizona
Ricklie Julian, MDPrincipal InvestigatorUniversity of Arizona
1 Previous Clinical Trials
7 Total Patients Enrolled

Eligibility Criteria

Age Any Age · All Participants · 15 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You can have two cancerous growths at the same time or two growths on opposite sides of your body.
You agree to provide tissue samples for research purposes, including a biopsy of the tumor before and during surgery.
References

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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" - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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