Ignite Creation Date:
2024-05-06 @ 3:19 AM
Last Modification Date:
2024-10-26 @ 11:31 AM
Study NCT ID:
NCT02254954
Status:
TERMINATED
Last Update Posted:
2018-02-27
First Post:
2014-09-23
Brief Title:
Clinical Study on Macitentan RT and TMZ Concurrent Therapy Followed by Maintenance Macitentan and TMZ in Newly Diagnosed Glioblastoma
Sponsor:
Actelion
Organization:
Actelion
Study Overview
Official Title:
A Single-center Open-label Phase 1 Study of Macitentan Radiotherapy and Temozolomide Concurrent Therapy Followed by Maintenance Therapy With Macitentan and Temozolomide in Subjects With Newly Diagnosed Glioblastoma
Status:
TERMINATED
Status Verified Date:
2018-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Sponsor decision due to low recruitment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a prospective single-center open-label 33 dose escalation Phase 1 safety study Adults with newly diagnosed GBM or gliosarcoma will receive macitentan in addition to the standard of care treatment for GBM The study consists of a screening period a treatment period and a 30-day safety follow up period The treatment period includes 6 weeks of concurrent therapy macitentanRTTMZ 4 weeks of monotherapy macitentan and 12 cycles of maintenance therapy macitentanTMZ The study will end when the last treated subject has completed study treatment and the 30-day safety follow-up period
The planned duration of the study is approximately 34-38 months depending on the number of dose levels and cohorts of subjects enrolled Subject participation in the study will be for approximately 16 months
The planned duration of the study is approximately 34-38 months depending on the number of dose levels and cohorts of subjects enrolled Subject participation in the study will be for approximately 16 months
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