Ignite Creation Date:
2024-05-06 @ 12:33 AM
Last Modification Date:
2024-10-26 @ 10:51 AM
Study NCT ID:
NCT01605162
Status:
TERMINATED
Last Update Posted:
2016-07-28
First Post:
2012-05-22
Brief Title:
Phase 2 Study of the PolyADP-Ribose Polymerase Inhibitor E7016 in Combination With Temozolomide in Subjects With Wild Type BRAF Stage IV or Unresectable Stage III Melanoma
Sponsor:
Eisai Inc
Organization:
Eisai Inc
Study Overview
Official Title:
Phase 2 Study of the PolyADP-Ribose Polymerase Inhibitor E7016 in Combination With Temozolomide in Subjects With Wild Type BRAF Stage IV or Unresectable Stage III Melanoma
Status:
TERMINATED
Status Verified Date:
2016-07
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:
This is a Phase 2 open-label multicenter study to assess the PFS-6m of E7016 at the selected dose of 320-mg once daily QD in combination with 150-mgm2 of Temozolomide TMZ in subjects with wt BRAF Stage IV or unresectable Stage III melanoma with disease progression Eligible subjects must have measurable disease according to Response Evaluation Criteria in Solid Tumors RECIST
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