Ignite Creation Date:
2024-05-05 @ 6:37 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00514007
Status:
COMPLETED
Last Update Posted:
2019-01-14
First Post:
2007-08-07
Brief Title:
Study of Continuous OSI-906 Dosing
Sponsor:
Astellas Pharma Inc
Organization:
Astellas Pharma Inc
Study Overview
Official Title:
A Phase I Dose Escalation Study of Continuous Oral OSI-906 Dosing in Patients With Advanced Solid Tumors
Status:
COMPLETED
Status Verified Date:
2019-01
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:
Multicenter open-label phase 1 cohort dose escalation study to determine the Maximum Tolerated Dose MTD on both Once Daily QD and Twice Daily BID schedules
Detailed Description:
Multicenter open-label phase 1 cohort dose escalation
The study will open with the QD schedule with initiation of the BID schedule occurring after observation of clinically significant related toxicity grade 2 in the QD schedule
Dosing will be initiated on Day 1 with daily dosing either QD or BID continuing for 21 days
Once the recommended phase 2 dose has been determined for the BID schedule 2 expansion cohorts will be opened 1 Biomarker Expansion Cohort in patients with locally advanced or metastatic colorectal cancer and 2 Diabetic Expansion Cohort in patients with advanced solid tumors who have active Type 2 diabetes mellitus not requiring insulin or insulinotropic therapy
The study will open with the QD schedule with initiation of the BID schedule occurring after observation of clinically significant related toxicity grade 2 in the QD schedule
Dosing will be initiated on Day 1 with daily dosing either QD or BID continuing for 21 days
Once the recommended phase 2 dose has been determined for the BID schedule 2 expansion cohorts will be opened 1 Biomarker Expansion Cohort in patients with locally advanced or metastatic colorectal cancer and 2 Diabetic Expansion Cohort in patients with advanced solid tumors who have active Type 2 diabetes mellitus not requiring insulin or insulinotropic therapy
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2006-005937-39 | EUDRACT_NUMBER | None | None |