Ignite Creation Date:
2024-05-06 @ 12:51 AM
Last Modification Date:
2024-10-26 @ 10:55 AM
Study NCT ID:
NCT01672736
Status:
TERMINATED
Last Update Posted:
2018-09-13
First Post:
2012-08-01
Brief Title:
A Trial of ASP7487 OSI-906 in Combination With Bortezomib for the Treatment of Relapsed Multiple Myeloma
Sponsor:
University Health Network Toronto
Organization:
University Health Network Toronto
Study Overview
Official Title:
A Phase 12 Trial of ASP7487 OSI-906in Combination With Bortezomib and Dexamethasone for the Treatment of Relapsed or RelapsedRefractory Multiple Myeloma
Status:
TERMINATED
Status Verified Date:
2018-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The Sponsor decided to stop further manufacture the study drug Linsitinib in Nov 2015
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a multi-center open-label non-randomized study Patients will receive ASP7487 OSI-906 in combination with bortezomib and dexamethasone Phase 1 involves dose escalation of the combination whereas Phase 2 involves the expansion of ASP7487 OSI-906 combined with bortezomib and dexamethasone at the MTD to establish the ORR This trial will accrue patients with relapsed or relapsedrefractory MM - a disease state for which bortezomib is approved to treat by the FDA and Health Canada The combination of ASP7487 OSI-906 with bortezomib is supported by pre-clinical work in MM in which the combination with an IGF1-R inhibitor enhances anti-tumor activity of bortezomib
Detailed Description:
The Phase 1 portion of the study will determine the MTD and DLTs of bortezomib administered on days 1 4 8 and 11 of a 21-day cycle combined with ASP7487 OSI-906 dosed twice daily orally continuously The combination of ASP7487 OSI-906 with bortezomib has not previously been tested The active agent bortezomib will be used during Cycle 1 - 8 at the recommended treatment dose of 13 mgm2 days 1 4 8 and 11 and Cycles 9 on days 1 8 15 and 22 of a 5-week cycle and ASP7487 OSI-906 will be dose escalated form 75 mg to 150mg utilizing 33 design
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