Actively Recruiting
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
Led by Dana-Farber Cancer Institute · Updated on 2026-04-29
38
Participants Needed
1
Research Sites
514 weeks
Total Duration
On this page
Sponsors
D
Dana-Farber Cancer Institute
Lead Sponsor
E
Eli Lilly and Company
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research study is studying a targeted therapy as a possible treatment for cancer abnormality in one of the following genes: CCND1, CCND2, CCND3, CDK4, or CDK6. The drug involved in this study is: -Abemaciclib
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must have a confirmed advanced solid tumor of non-breast origin without effective standard therapy.
- For Arm 1: Confirmed CCND1, CCND2, or CCND3 high-level amplification, mutation, or splice variant causing cyclin D1 nuclear retention.
- For Arm 2: Confirmed CDK4 or CDK6 high-level amplification.
- Participants must have measurable or evaluable disease.
- Age 18 years or older.
- ECOG performance status of 0 or 1.
- Normal organ and marrow function with specific laboratory values for neutrophils, platelets, bilirubin, liver enzymes, and kidney function.
- Women of childbearing potential and men must agree to use effective contraception during and for 3 months after treatment.
- Negative pregnancy test for women of childbearing potential before enrollment.
- Ability to understand and sign informed consent.
- Ability to swallow and retain oral medication.
You will not qualify if you...
- Chemotherapy, biologic therapy, investigational drugs, radiotherapy, or major surgery within 4 weeks before study entry (6 weeks for certain drugs).
- Oral targeted therapy or tyrosine kinase inhibitors within 5 half-lives before study entry.
- Prior treatment with a CDK4/6 inhibitor.
- Ongoing toxicity or adverse events from previous treatments.
- Receiving other investigational agents.
- Hematologic lymphoma.
- Symptomatic and neurologically unstable CNS metastases requiring radiation therapy.
- History of allergic reactions to compounds similar to Abemaciclib.
- Uncontrolled illnesses such as active infection, heart failure, unstable angina, arrhythmia, or psychiatric/social conditions limiting compliance.
- Pregnant or breastfeeding women.
- Known HIV positive status.
- Known active Hepatitis B or C infection.
- Use of enzyme-inducing antiepileptic drugs that cannot be changed prior to treatment initiation.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Actively Recruiting
Research Team
G
Geoffrey Shapiro, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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