Status:
WITHDRAWN
A New Agent GM-CT-01 in Combination With 5-FU, Avastin and Leucovorin in Subjects With Colorectal Cancer
Lead Sponsor:
Galectin Therapeutics Inc.
Conditions:
Colorectal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this clinical trial is to determine whether the combination of 5-fluorouracil (5-FU) plus a DAVANAT (carbohydrate polymer) along with Avastin and Leucovorin (LV) is beneficial in treati...
Detailed Description
This is a Phase II, multi-center study of DAVANAT which has been shown to increase the anti-tumor activity of 5-FU in mice. 5-FU is a chemotherapy drug commonly used to treat tumors. A Phase I study o...
Eligibility Criteria
Inclusion
- 18 years or older.
- Histologically confirmed, unresectable, locally advanced or metastatic colorectal adenocarcinoma (stage III and IV), not amenable to curative surgery or radiotherapy.
- Intolerant of oxaliplatin and/or irinotecan, as demonstrated by unacceptable toxicity after a trial of these agents as first-line therapy, or in the opinion of the Investigator, be judged at high risk for unacceptable toxicity to oxaliplatin and/or irinotecan,
- Presence of at least 1 measurable lesion,
- Have a life expectancy of at least 4 months.
- Women of childbearing potential, have a negative serum pregnancy test at screening and Day 1 treatment and agree to practice abstinence or use an effective method of contraception.
Exclusion
- Central nervous system metastasis.
- Bony metastasis as the sole metastasis.
- Received any prior first-line chemotherapy for colorectal cancer.
- Previously exposed to DAVANAT® or Avastin®.
- Known or clinically suspected infection with HIV.
- Participated within 30 days or will participate concurrently in another investigational drug or vaccine study.
- History of drug or alcohol dependence in the past 3 years.
- Other serious, non-malignant, significant, acute or chronic medical or psychiatric illness that in the judgment of the Investigator could compromise subject safety, limit the subject's ability to complete the study, and/or compromise the objectives of the study.
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00388700
Start Date
October 1 2006
End Date
June 1 2009
Last Update
February 14 2018
Active Locations (4)
Enter a location and click search to find clinical trials sorted by distance.
1
Rambam Medical Center
Haifa, Israel, 31096
2
Kaplan MC
Rehovot, Israel
3
Sourasky Medical Center
Tel Aviv, Israel, 64239
4
Sheba MC
Tel Litwinsky, Israel, 52621