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

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

First listed
Oct 16, 2017
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
617-632-4942
Geoffrey Shapiro, MD (PRINCIPAL_INVESTIGATOR)

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