A Phase 1/1b, Open-label Study in Patients With Recurrent Glioblastoma to Assess the Safety and Tolerability of Macitentan in Combination With Dose-dense Temozolomide.

Trial Profile

A Phase 1/1b, Open-label Study in Patients With Recurrent Glioblastoma to Assess the Safety and Tolerability of Macitentan in Combination With Dose-dense Temozolomide.

Discontinued
Phase of Trial: Phase I

Latest Information Update: 09 May 2016

At a glance

  • Drugs Macitentan (Primary) ; Temozolomide
  • Indications Glioblastoma
  • Focus Adverse reactions; Biomarker
  • Sponsors Actelion Pharmaceuticals
  • Most Recent Events

    • 04 May 2016 Status changed from recruiting to discontinued as the results did not clearly support continuing development in recurrent GBM.
    • 30 Jan 2015 Additional doses of 225 mg, 300 mg and 375 mg have been added to the dose schedule according to ClinicalTrials.gov
    • 25 Jan 2015 Planned number of patients changed from 48 to 75 as reported by ClinicalTrials.gov
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