Abemaciclib w/Bevacizumab in Recurrent GBM Pts w/Loss of CDKN2A/B or Gain or Amplification of CDK4/6

Part of paid clinical trials in Dallas, Texas.

Sponsor
University of Texas Southwestern Medical Center
Study ID
NCT04074785
Phase
EARLY_PHASE1
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • Abemaciclib — DRUG
    Abemaciclib 150 mg po bid
  • Bevacizumab — DRUG
    Bevacizumab 10 mg/kg IV every 2 weeks, then continue treatments for 2 cycles

Study Details

Describe the safety and adverse events associated with Abemaciclib 150 mg orally twice daily when administered with Bevacizumab 10 mg/kg intravenously every 2 weeks to recurrent GBM patients with specific tumor molecular aberrations

Key Dates

First listed
Aug 30, 2019
Start date
Dec 13, 2019
Status verified
Aug 2025
Primary completion
Oct 16, 2023
Completion
Oct 16, 2023

Study Design

Enrollment
10 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Safety Run-In
    Abemaciclib 150 mg po bid PLUS Bevacizumab 10 mg/kg IV every 2 weeks, then continue treatments for 2 cycles
  • Experimental: Abemaciclib with Bevacizumab
    Abemaciclib 100 mg po bid PLUS Bevacizumab 10 mg/kg IV every 2 weeks, then continue treatments for 2 cycles

Primary Outcome Measure

Number of participants with adverse event [ Time Frame: upto 2 years after study treatment ]

Locations (1)

FacilityCityStateZIPSite coordinators
UT Southwestern Medical CenterDallasTexas75390-

Find similar trials in Dallas, TX

By condition
Brain cancer
By specialty
OncologyNeuro-oncology
By research site
UT Southwestern Medical Center· Dallas, TX

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