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.
Phase of Trial: Phase I
Latest Information Update: 09 May 2016
At a glance
- Drugs Macitentan (Primary) ; Temozolomide
- Indications Glioblastoma; Gliosarcoma
- Focus Adverse reactions; Biomarker
- Sponsors Actelion Pharmaceuticals
- 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