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

  • End date
    Apr 30, 2025
  • participants needed
  • sponsor
    Dana-Farber Cancer Institute
Updated on 24 March 2022
measurable disease
neutrophil count
liver metastasis
primary cancer
solid tumour
solid tumor
targeted therapy
solid neoplasm


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:



This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational drug to learn whether the drug works in treating a specific disease. "Investigational" means that the drug is being studied.

The FDA (the U.S. Food and Drug Administration) has not approved Abemaciclib as a treatment for any disease.

To participate in this study, the participant must have an abnormality in one of the following genes: CCND1, CCND2, CCND3, CDK4, or CDK6. Abnormalities in these genes may cause the cancer to grow more rapidly. CDK4 and CDK6 are proteins that are involved with the cell growth process. D-type cyclins (CCND1, CCND2, and CCND3) are proteins that help control the activity of CDK4 and CDK6.

Abemaciclib is being studied as a treatment for people with advanced cancer. Abemaciclib is a cyclin-dependent kinase (CDK) inhibitor. CDK inhibitors work to stop cell growth. In this research study, the investigators are hoping to learn whether Abemaciclib can be used to slow or stop the growth of cancers with specific genetic abnormalities.

Condition Cancer
Treatment Abemaciclib
Clinical Study IdentifierNCT03310879
SponsorDana-Farber Cancer Institute
Last Modified on24 March 2022


Yes No Not Sure

Inclusion Criteria

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 1: Participants must have a confirmed CCND1, 2, or 3 high-level amplification, CCND1 mutation, or a CCND1 splice variant expected to lead to nuclear retention of cyclin D1 protein, via DFCI/BWH OncoPanel or any CLIA-certified method
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
Participants must have evaluable or measurable disease
Age ≥ 18 years
ECOG performance status of 0-1 (see APPENDIX A)
Participants must have normal organ and marrow function as defined below
Absolute neutrophil count ≥1,500/mcL
Platelets ≥100,000/mcL
Total bilirubin ≤ 1.5 × institutional upper limit of normal (ULN)
AST(SGOT)/ALT(SGPT) ≤ 2.5 × institutional (ULN) -OR-
AST(SGOT)/ALT(SGPT) ≤ 5 × institutional (ULN) if liver metastases are present
Serum Creatinine ≤ 1.5 × institutional ULN -OR-
Creatinine clearance ≥ 60 mL/min (Cockroft-Gault Equation)
The effects of abemaciclib on the developing human fetus are unknown. For this reason
women of child-bearing potential and men must agree to use adequate
Ability to understand and the willingness to sign a written informed consent document
contraception (hormonal or barrier method of birth control; abstinence) prior
Ability to swallow and retain oral medication
to study entry, for the duration of study participation, and for 3 months
after completion of abemaciclib administration. Should a woman become pregnant
or suspect she is pregnant while she or her partner is participating in this
study, she should inform her treating physician immediately. A negative serum
pregnancy test is required for women of childbearing potential prior to study

Exclusion Criteria

Participants who have had chemotherapy, biologic therapy, investigational agents, radiotherapy, or major surgery within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study
Participants who have had oral targeted therapy or oral tyrosine kinase inhibitors (TKIs) within 5 half-lives prior to entering the study
Participants who have received prior treatment with a CDK4/6 inhibitor
Participants must have recovered to eligibility levels from prior toxicity or adverse events as a result of previous treatment prior to entering the study
Participants who are receiving any other investigational agents
Participants with hematologic lymphoma
Participants with symptomatic CNS metastases who are neurologically unstable and/or require radiation therapy are excluded
Participants with brain metastases that do not meet the above criteria in the opinion of the treating investigator are allowed
Symptomatic disease is allowed as long as symptoms are controlled and stable
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
Pregnant women are excluded from this study because abemaciclib is an agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with abemaciclib, breastfeeding should be discontinued if the mother is treated with abemaciclib. A negative serum pregnancy test is required for women of childbearing potential prior to study entry
Participants with known HIV-positive status are ineligible because these participants are at increased risk of lethal infections when treated with marrow-suppressive therapy. Appropriate studies will be undertaken in participants receiving combination antiretroviral therapy when indicated
Participants with known active Hepatitis B or Hepatitis C
Participants receiving an enzyme-inducing antiepileptic drug (EIAED) who cannot be transferred to a non-EIAED (e.g., levetiracetam, lacosamide, lamotrigine, etc.) prior to the initiation of protocol therapy
History of allergic reactions attributed to compounds of similar chemical or biologic
composition to abemaciclib
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How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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