Ignite Creation Date:
2024-05-05 @ 5:12 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00408226
Status:
COMPLETED
Last Update Posted:
2012-01-20
First Post:
2006-12-05
Brief Title:
Safety Study of MKC-1 Combined With Pemetrexed to Treat Advanced Cancer and Non-Small Cell Lung Cancer
Sponsor:
CASI Pharmaceuticals Inc
Organization:
CASI Pharmaceuticals Inc
Study Overview
Official Title:
Phase 12 Study of Oral MKC-1 Administered Twice Daily for 14 Consecutive Days Every 3 Weeks in Combination With Pemetrexed
Status:
COMPLETED
Status Verified Date:
2012-01
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:
To determine the toxicities maximum tolerated dose MTD and recommended phase 2 dose of MKC-1 when administered orally twice daily for 14 days followed by 7 days without dosing in combination with pemetrexed delivered at its recommended single agent dose to patients with advanced solid tumor malignancies Also to determine the antitumor activity based on the objective response rate and median Progression Free Survival PFS of oral MKC-1 administered on this schedule in combination with pemetrexed to patients with non small cell lung cancer NSCLC
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