Ignite Creation Date:
2024-05-05 @ 11:28 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00046696
Status:
COMPLETED
Last Update Posted:
2015-05-20
First Post:
2002-10-01
Brief Title:
A Study of NM-3 Administered Orally in Patients With Advanced Solid Tumors
Sponsor:
Genzyme a Sanofi Company
Organization:
Sanofi
Study Overview
Official Title:
A Phase I and Pharmacokinetic Study of NM-3 Administered Orally Once or Twice Daily on Five Consecutive Days and Repeated Weekly for Six Weeks Every Eight Weeks in Patients With Advanced Solid Tumors
Status:
COMPLETED
Status Verified Date:
2015-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A study for patients who have failed standard therapy If there is no dose limiting toxicities the patients will receive further cycles of therapy if there is no evidence of disease progression
Detailed Description:
This is a non-randomized open-label Phase I study A modified Fibonacci dose escalation will be used to determine the MTD for subsequent Phase II trials Study duration is expected to be 12 to 18 months Patients with a histological or cytological diagnosis of a solid tumor who have failed standard therapy or for whom no standard therapy exists are enrolled If there is no dose limiting toxicities and if patients meet the inclusion criteria and have none of the exclusion criteria of the protocol they will receive further cycles of therapy if there is no evidence of disease progression
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