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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
Must not have
Participants with symptomatic CNS metastases who are neurologically unstable and/or require radiation therapy
Participants who had recent chemotherapy, biologic therapy, investigational agents, radiotherapy, or major surgery
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
No Placebo-Only Group
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.
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.
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 belowSelect...
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.
Select...
I am fully active or can carry out light work.
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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.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have brain metastases causing symptoms and need radiation.
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I haven't had recent major cancer treatments or surgery.
Select...
I have been treated with a CDK4/6 inhibitor before.
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I have been diagnosed with lymphoma.
Select...
I have active Hepatitis B or C.
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I am on a specific seizure medication that cannot be changed before starting the trial treatment.
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I do not have any unmanaged ongoing illnesses.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Progression-Free Rate
Secondary study objectives
Overall Response Rate
Toxicity
Side 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%
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
9%
Stomatitis
9%
Aspartate aminotransferase increased
8%
Thrombocytopenia
8%
Lacrimation increased
8%
Dehydration
8%
Dry skin
8%
Pruritus
8%
Alanine aminotransferase increased
7%
Flatulence
7%
Upper respiratory tract infection
7%
Urinary tract infection
7%
Hypokalaemia
6%
Chills
6%
Musculoskeletal chest pain
6%
Musculoskeletal pain
6%
Anxiety
5%
Gastrooesophageal reflux disease
5%
Rash
5%
Myalgia
2%
Cellulitis
2%
Pleural effusion
1%
Atypical pneumonia
1%
Gastroenteritis viral
1%
Lung infection
1%
Sepsis
1%
Fall
1%
Hip fracture
1%
Pneumonitis
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
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
~1890
Find a Location
Who is running the clinical trial?
Eli Lilly and CompanyIndustry Sponsor
2,680 Previous Clinical Trials
3,466,346 Total Patients Enrolled
Dana-Farber Cancer InstituteLead Sponsor
1,113 Previous Clinical Trials
358,843 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
306 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have brain metastases causing symptoms and need radiation.I can swallow and keep down pills.I have fully recovered from any side effects of previous treatments.I have been diagnosed with lymphoma.My advanced cancer is not breast cancer and standard treatments no longer work or don't exist for it.My cancer has a high level of CDK4 or CDK6, confirmed by a specific test.My cancer has a specific change in the CCND1, 2, or 3 gene.I am fully active or can carry out light work.I haven't had recent major cancer treatments or surgery.I have taken oral cancer medication recently.I have been treated with a CDK4/6 inhibitor before.My blood counts and liver/kidney functions are within normal ranges.I have active Hepatitis B or C.I am on a specific seizure medication that cannot be changed before starting the trial treatment.I do not have any unmanaged ongoing illnesses.I am 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: Participants with CCND1, CCND2, or CCND3
- Group 2: Participants with CDK4 or CDK6
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.