Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00054977
Status:
COMPLETED
Last Update Posted:
2012-03-12
First Post:
2003-02-14
Brief Title:
Safety of GM-CT-01 With and Without 5-Fluorouracil in Patients With Solid Tumors
Sponsor:
Galectin Therapeutics Inc
Organization:
Galectin Therapeutics Inc
Study Overview
Official Title:
A Phase I Open-Label Study to Evaluate the Safety and Tolerability of Escalating Doses of GM-CT-01 in the Presence and Absence of 5-Fluorouracil 5-FU in Subjects With Advanced Solid Tumors
Status:
COMPLETED
Status Verified Date:
2012-03
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:
This is a Phase I multi-center study of GM-CT-01 which has been shown to increase the anti-tumor activity of 5-fluorouracil in mice The primary reason for doing the study is to determine the safety of GM-CT-01 given alone and in combination with therapeutical dosage of 5-Fluorouracil in patients who have advanced cancer that can be measured by CT scan
Detailed Description:
5-Fluorouracil is a chemotherapy drug commonly used in cancer patients Patients with different type of solid tumors who have failed standard approved treatments can be enrolled in the study Escalated doses of GM-CT-01 will be given alone in Cycle 1 and in combination with 5-fluorouracil in cycle 2 Patients will be on study for approximately 60 days for determination of safety However with patient consent treatment can continue until disease progression is determined by CT scan The study secondary reason is to determine whether treatment has stabilize the tumors or change it in size get bigger smaller or stay the sameafter Cycle 2 and any additional cycles of treatment
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