Study on the CDK4/6 Inhibitor Abemaciclib for Solid Tumors with Genetic Changes in D-type Cyclins or CDK4/CDK6 Amplification

Sponsor: Dana-Farber Cancer Institute

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT03310879

Provider View

This clinical trial is exploring a new treatment using the drug Abemaciclib for patients with certain genetic changes in their cancer, specifically in genes related to cell growth. The study aims to see if Abemaciclib can help slow or stop the growth of these cancers.

Patient Parameters

Program Overview

This study is testing a new drug called Abemaciclib to see if it can treat cancers with specific genetic changes. These changes are in genes that help control cell growth, such as CCND1, CCND2, CCND3, CDK4, or CDK6. Abemaciclib is a type of drug that aims to stop cancer cells from growing. The study is in Phase II, which means it is checking how safe and effective the drug is for treating these cancers. The U.S. Food and Drug Administration (FDA) has not yet approved Abemaciclib for treating any disease.

Description

This clinical trial is for patients with advanced solid tumors that have specific genetic changes. These changes can make cancer grow faster. The study is testing Abemaciclib, a drug that may help slow down or stop cancer growth by targeting proteins involved in cell growth. Participants must have a genetic abnormality in one of the following genes: CCND1, CCND2, CCND3, CDK4, or CDK6. The study will help researchers learn if Abemaciclib can be an effective treatment for these types of cancer.

Eligibility Criteria

Inclusion Criteria

  • Have a confirmed advanced solid tumor that is not breast cancer, where standard treatments are not available or no longer work.
  • For Arm 1: Have a confirmed high-level amplification or mutation in CCND1, 2, or 3, or a specific CCND1 variant.
  • For Arm 2: Have a confirmed high-level amplification in CDK4 or CDK6.
  • Have measurable disease that can be evaluated.
  • Be 18 years or older.
  • Have a performance status score of 0 or 1, meaning fully active or restricted in strenuous activity but ambulatory.
  • Have normal organ and bone marrow function, including specific blood counts and liver and kidney function tests.
  • Agree to use effective birth control during the study and for 3 months after, if of childbearing potential.
  • Be able to understand and sign a consent form.
  • Be able to swallow pills.

Exclusion Criteria

  • Have had recent chemotherapy, biologic therapy, investigational agents, radiotherapy, or major surgery within the last 4 weeks (6 weeks for certain drugs).
  • Have taken oral targeted therapy or tyrosine kinase inhibitors recently.
  • Have previously been treated with a CDK4/6 inhibitor.
  • Have not recovered from side effects of previous treatments.
  • Are currently receiving other investigational drugs.
  • Have blood-related cancers like lymphoma.
  • Have unstable brain metastases requiring treatment.
  • Have a history of severe allergic reactions to similar drugs.
  • Have uncontrolled illnesses like infections, heart failure, or psychiatric conditions.
  • Are pregnant or breastfeeding.
  • Have known HIV, active Hepatitis B or C.
  • Are taking certain epilepsy medications that cannot be changed.

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