Spots Global Cancer Trial Database for Evaluation of Eflornithine Plus Temozolomide in Patients With Newly Diagnosed Glioblastoma
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Trial Identification
Brief Title: Evaluation of Eflornithine Plus Temozolomide in Patients With Newly Diagnosed Glioblastoma
Official Title: An Open-label, Phase 1b Study to Evaluate the Safety and Tolerability of Eflornithine Plus Temozolomide in Patients With Newly Diagnosed Glioblastoma
Study ID: NCT05879367
Study Description
Brief Summary: The purpose of this study is to establish the recommended phase 2 dose of eflornithine in combination with temozolomide in patients whose glioblastoma is newly diagnosed, and to evaluate safety and tolerability of this combination at that dose.
Detailed Description: This open label dose escalation and expansion study will be conducted using a standard dose-escalation design with escalating doses of eflornithine plus temozolomide at the approved dose level, followed by an expansion cohort that will further evaluate safety and preliminary efficacy of the combination at the recommended phase 2 dose. Duration of participation will be up to 56 weeks in total per patient: Screening Period - A maximum screening duration of 4 weeks. Treatment Period - Up to 48 weeks. Follow-Up Visit - 4 weeks from last treatment. A total of up to 66 patients will be enrolled in a non-randomized fashion (patients may be added to any of the dose levels below the RP2D to a maximum of approximately 20 per dose level with the intent of further characterizing safety and pharmacokinetics).
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of Alabama at Birmingham, Birmingham, Alabama, United States
Henry Ford Hospital, Detroit, Michigan, United States
Columbia University Medical Center - Herbert Irving Pavilion, New York, New York, United States
Duke University, Durham, North Carolina, United States
The Cleveland Clinic, Cleveland, Ohio, United States
Lifespan Cancer Institute/Rhode Island Hospital, Providence, Rhode Island, United States
UT MD Anderson Cancer Center, Houston, Texas, United States
University of Utah, Huntsman Cancer Institute, Salt Lake City, Utah, United States
Contact Details
Name: Howard Colman, MD, PhD
Affiliation: Huntsman Cancer Institute/ University of Utah
Role: PRINCIPAL_INVESTIGATOR
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