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CDK4/6 Inhibitor

Abemaciclib for Cancer

Phase 2
Recruiting
Led By Geoffrey Shapiro, MD, PhD
Research Sponsored by Dana-Farber Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participants must have a histologically or cytologically confirmed advanced solid tumor of a non-breast origin, for which standard therapy proven to provide clinical benefit does not exist or is no longer effective
For enrollment to Arm 2: Participants must have a confirmed CDK4 or CDK6 high-level amplification, identified via DFCI/BWH OncoPanel or any CLIA-certified method
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

Study Summary

This trial is studying how well abemaciclib works in treating patients with cancer that has a certain gene abnormality.

Who is the study for?
Adults with advanced solid tumors not originating from breast tissue, who have specific genetic alterations in CCND1/2/3 or CDK4/6 and no standard treatment options left. They must be physically capable of taking oral medication, have stable vital organ functions, and agree to use contraception. Excluded are those with recent treatments, certain metastases, active hepatitis B/C or HIV, pregnant or breastfeeding women.Check my eligibility
What is being tested?
The trial is testing Abemaciclib's effectiveness on cancers with certain gene abnormalities. Participants will receive this targeted therapy orally. The study includes two arms based on different genetic alterations related to cyclins D1/D2/D3 and CDK4/6 amplification.See study design
What are the potential side effects?
Abemaciclib may cause fatigue, diarrhea, low blood cell counts increasing infection risk, liver enzyme changes suggesting liver injury, deep vein thrombosis (blood clots), pulmonary embolism (lung artery blockage), and potential harm to a developing fetus.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My advanced cancer is not breast cancer and standard treatments no longer work or don't exist for it.
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My cancer has a high level of CDK4 or CDK6, confirmed by a specific test.
Select...
My cancer has a specific change in the CCND1, 2, or 3 gene.
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I am fully active or can carry out light work.
Select...
I can swallow and keep down pills.
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My blood counts and liver/kidney functions are within normal ranges.
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I am 18 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Progression-Free Rate
Secondary outcome measures
Overall Response Rate
Toxicity

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
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

2Treatment groups
Experimental Treatment
Group I: Participants with CDK4 or CDK6Experimental Treatment1 Intervention
Abemaciclib will be administered orally on a daily basis Dosage will be determine by the PI
Group II: Participants with CCND1, CCND2, or CCND3Experimental Treatment1 Intervention
Abemaciclib will be administered orally on a daily basis Dosage will be determine by the PI
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?

Eli Lilly and CompanyIndustry Sponsor
2,619 Previous Clinical Trials
3,206,560 Total Patients Enrolled
Dana-Farber Cancer InstituteLead Sponsor
1,079 Previous Clinical Trials
340,943 Total Patients Enrolled
Geoffrey Shapiro, MD, PhDPrincipal Investigator - Dana-Farber Cancer Institute
Dana-Farber Cancer Institute
Joan And Stanford I. Weill Medical College Of Cornell Uni (Medical School)
Brigham & Women'S Hospital (Residency)
7 Previous Clinical Trials
219 Total Patients Enrolled

Media Library

Abemaciclib (CDK4/6 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03310879 — Phase 2
Cancer Research Study Groups: Participants with CCND1, CCND2, or CCND3, Participants with CDK4 or CDK6
Cancer Clinical Trial 2023: Abemaciclib Highlights & Side Effects. Trial Name: NCT03310879 — Phase 2
Abemaciclib (CDK4/6 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03310879 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what degree is Abemaciclib a hazard to patients?

"Abemaciclib has been rated a 2 on the safety scale as it is currently undergoing Phase 2 of development, which shows initial signs of efficacy but no conclusive evidence yet."

Answered by AI

Are there any open vacancies available to join the research?

"According to the information found on clinicaltrials.gov, this medical experiment is in search of volunteers and has been since November 21st 2017; its most recent update was documented on January 18th 2022."

Answered by AI

Is Abemaciclib typically employed to combat specific health issues?

"Abemaciclib is often employed to reduce the probability of relapsing in patients. It also proves helpful for treating a variety of medical issues, including advanced HR+ HER2- breast cancer, endocrine therapy related diseases, and additional forms of breast malignancy."

Answered by AI

Is this an unprecedented research endeavor?

"Currently, there are 92 active Abemaciclib trials being conducted in 1276 cities and 41 nations. This is the continuation of Eli Lilly's 2009 trial which sought to complete Phase 1 approval with 220 participants. Since then, 31 more studies have terminated successfully."

Answered by AI

How many individuals are engaged in this trial's research?

"Affirmative. The information on clinicaltrials.gov states that this experiment is recruiting volunteers, with the original posting date of November 21st 2017 and most recent update on January 18th 2022. 38 people need to be enlisted from a single facility for the trial's success."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Study of the CDK4/6 Inhibitor Abemaciclib in Solid Tumors Harboring Genetic Alterations in Genes Encoding D-type Cyclins or Amplification of CDK4 or CDK6
Geoffrey Shapiro, MD, PhD 2017. "Study of the CDK4/6 Inhibitor Abemaciclib in Solid Tumors Harboring Genetic Alterations in Genes Encoding D-type Cyclins or Amplification of CDK4 or CDK6". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03310879.
~4 spots leftby Dec 2024
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