Ignite Creation Date:
2024-05-05 @ 9:58 PM
Last Modification Date:
2024-10-26 @ 10:12 AM
Study NCT ID:
NCT01009177
Status:
COMPLETED
Last Update Posted:
2015-04-30
First Post:
2009-10-14
Brief Title:
Effect of Bosentan in Patients With Metastatic Melanoma Treated With Dacarbazine DTIC
Sponsor:
Actelion
Organization:
Actelion
Study Overview
Official Title:
A Multicenter Randomized Double-blind Placebo-controlled Phase II Study to Evaluate the Effect of Bosentan in Patients With Stage IV Metastatic Melanoma Treated With Dacarbazine
Status:
COMPLETED
Status Verified Date:
2015-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The study is designed as a multicenter double blind parallel-group placebo-controlled randomized event driven Phase II study of DTIC with or without bosentan as first-line treatment in patients with stage IV melanoma
Detailed Description:
This is a randomized double-blind 11 bosentan placebo trial to evaluate the effect of bosentan in combination with DTIC on TTP or death in patients with metastatic melanoma stage IV
The patients will receive study medication bosentan or placebo and DTIC for 35 weeks to 105 weeks the study will be completed when 66 events tumor progression death due to underlying disease otheradditional anti-tumor therapy have been observed
Study drug will be administered orally 500 mg twice a day DTIC will be given once every three weeks in a dosage of 1000 mgm2 intravenously iv or in accordance with the Institutions DTIC treatment protocol
The patients will receive study medication bosentan or placebo and DTIC for 35 weeks to 105 weeks the study will be completed when 66 events tumor progression death due to underlying disease otheradditional anti-tumor therapy have been observed
Study drug will be administered orally 500 mg twice a day DTIC will be given once every three weeks in a dosage of 1000 mgm2 intravenously iv or in accordance with the Institutions DTIC treatment protocol
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