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Clinical Trial 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.


Clinical Trial 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). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05879367
Study type Interventional
Source Orbus Therapeutics, Inc.
Contact Monika Varga
Phone 6506569424
Email monika.varga@orbustherapeutics.com
Status Recruiting
Phase Phase 1
Start date July 24, 2023
Completion date December 15, 2024

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