Ignite Creation Date:
2024-05-06 @ 12:08 AM
Last Modification Date:
2024-10-26 @ 10:45 AM
Study NCT ID:
NCT01499251
Status:
TERMINATED
Last Update Posted:
2016-05-05
First Post:
2011-12-20
Brief Title:
Clinical Study on the Safety and Tolerability of Macitentan in Combination With Dose-dense Temozolomide in Patients With Recurrent Glioblastoma
Sponsor:
Actelion
Organization:
Actelion
Study Overview
Official Title:
A Phase 11b Open-label Study in Patients With Recurrent Glioblastoma to Assess the Safety and Tolerability of Macitentan in Combination With Dose-dense Temozolomide
Status:
TERMINATED
Status Verified Date:
2016-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Results did not clearly support continuing development in recurrent GBM
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is an open-label single arm Phase 1 study to assess the safety and tolerability of macitentan in combination with dose-dense temozolomide in adult patients with recurrent glioblastoma or gliosarcoma The study is composed of three parts A Phase 1 Dose Escalation Period with a traditional 33 design will determine the maximum tolerated dose of macitentan in combination with dose-dense temozolomide A Phase 1b Period will expand the safety and tolerability data of two doses of macitentan and dose-dense temozolomide selected from the Dose Escalation Period and explore efficacy An Ancillary Study will further evaluate the effects of macitentan on biomarkers in brain tumor tissue
The study is planned to have a minimum duration of 12 months The study will end when all patients excluding those prematurely withdrawn or lost to follow-up in each part of the study have completed a visit at month 12 and 30 days of safety follow-up
The study is planned to have a minimum duration of 12 months The study will end when all patients excluding those prematurely withdrawn or lost to follow-up in each part of the study have completed a visit at month 12 and 30 days of safety follow-up
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None