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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Dana-Farber Cancer Institute
Study ID
NCT03310879
Phase
PHASE2
Status
Recruiting
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Conditions

  • Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Abemaciclib — DRUG
    Abemaciclib is a cyclin-dependent kinase (CDK) inhibitor. CDK inhibitors work to stop cell growth.

Study Details

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

Key Dates

Start date
Nov 21, 2017
Status verified
Apr 2026
Primary completion
Jan 1, 2027
Completion
Sep 30, 2027

Study Design

Enrollment
38 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Participants with CCND1, CCND2, or CCND3
    * Abemaciclib will be administered orally on a daily basis * Dosage will be determine by the PI
  • Experimental: Participants with CDK4 or CDK6
    * Abemaciclib will be administered orally on a daily basis * Dosage will be determine by the PI

Primary Outcome Measure

Progression-Free Rate [ Time Frame: 4 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Dana Farber Cancer InstituteBostonMassachusetts02115
Geoffrey Shapiro
[email protected]
617-632-4942
Geoffrey Shapiro, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Dana Farber Cancer Institute· Boston, MA

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