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

STATUS

Recruiting
End date

Apr 30, 2025
participants needed

38
sponsor

Dana-Farber Cancer Institute

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Updated on 24 March 2022

See if I qualify

measurable disease

metastasis

neutrophil count

liver metastasis

primary cancer

solid tumour

solid tumor

targeted therapy

solid neoplasm

Summary

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

Description

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.

Details

Condition	Cancer
Treatment	Abemaciclib
Clinical Study Identifier	NCT03310879
Sponsor	Dana-Farber Cancer Institute
Last Modified on	24 March 2022

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Eligibility		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
	entry
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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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