A New Agent GM-CT-01 in Combination With 5-FU, Avastin and Leucovorin in Subjects With Colorectal Cancer

Galectin Therapeutics

Status and phase

Withdrawn

Phase 2

Conditions

Colorectal Cancer

Treatments

Drug: 5-Fluorouracil, Leukovorin, bevacizumab

Drug: GM-CT-01

Study type

Interventional

Funder types

Industry

Identifiers

NCT00388700

DAVFU006

Details and patient eligibility

About

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 treating colorectal cancer in patients unable to tolerate intensive chemotherapy.

Full 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 of 40 patients showed that DAVANAT in different doses plus 5-FU was well tolerated in patients with different types of solid tumors who failed standard, approved treatments.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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.