Ignite Creation Date:
2024-05-05 @ 6:37 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00513851
Status:
COMPLETED
Last Update Posted:
2011-09-27
First Post:
2007-08-07
Brief Title:
Phase 1 Study of OSI-930 in Cancer Patients
Sponsor:
Astellas Pharma Inc
Organization:
Astellas Pharma Inc
Study Overview
Official Title:
A Phase I Dose Escalation Study of Daily Oral OSI-930 in Patients With Advanced Solid Tumors
Status:
COMPLETED
Status Verified Date:
2011-09
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:
Open label phase 1 dose escalation
Detailed Description:
Multicenter open-label phase 1 dose escalation study to determine the maximum tolerated dose on both once daily QD and twice daily BID schedules
Patients may continue to receive OSI-930 until one of the following occurs disease progression adverse event requiring withdrawal failure to recover from toxicity despite a 14-day dosing interruption medical or ethical reasons patient request or patient death
Patients may continue to receive OSI-930 until one of the following occurs disease progression adverse event requiring withdrawal failure to recover from toxicity despite a 14-day dosing interruption medical or ethical reasons patient request or patient death
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