Open-label Phase 1b Study Evaluating Safety and Tolerability of Eflornithine Plus Temozolomide in Adults With Newly Diagnosed Glioblastoma or Astrocytoma

What this Trial Is About

Researchers are evaluating the recommended phase 2 dose of eflornithine combined with temozolomide in patients newly diagnosed with glioblastoma or astrocytoma. This phase 1b open-label study aims to assess the safety and tolerability of this drug combination. The study is sponsored by Orbus Therapeutics, Inc., and involves patients with newly diagnosed brain tumors classified by the World Health Organization. Participants will receive escalating doses of eflornithine along with a standard dose of temozolomide. Eflornithine is given orally every 8 hours on a schedule of 2 weeks on treatment followed by 2 weeks off, with doses of 1.75, 2.3, or 2.8 gm2 under evaluation. Temozolomide is taken orally once daily for 5 days followed by 23 days off. The study includes a dose escalation phase followed by an expansion cohort to further assess safety and early effectiveness of the combination at the recommended dose. Participants will be involved for up to approximately 104 weeks, including screening lasting up to 4 weeks, the treatment period, and a follow-up visit 4 weeks after treatment ends. Long-term survival follow-up will continue for up to 2 years after last treatment. Researchers will monitor dose limiting toxicities, treatment-emergent adverse events, vital signs, laboratory test abnormalities, and pharmacokinetics. They will also assess overall survival, progression-free survival, and response rates to evaluate the drug combination.

Evaluation of Eflornithine Plus Temozolomide in Patients With Newly Diagnosed Glioblastoma or Astrocytoma