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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT00388700
• Date of registration: 13/10/2006
• Prospective Registration: No
• Primary sponsor: Galectin Therapeutics Inc.
• Public title: A New Agent GM-CT-01 in Combination With 5-FU, Avastin and Leucovorin in Subjects With Colorectal Cancer
• Scientific title: Open-Label, Phase 2 Study of GM-CT-01 When Added to a Regimen of Leucovorin, 5-FU, and Avastin as First Line Treatment for Locally Advanced, Unresectable or Metastatic Colorectal Cancer in Subjects Unable to Tolerate Intensive Chemotherapy
• Date of first enrolment: October 2006
• Target sample size: 0
• Recruitment status: Withdrawn
• URL: https://clinicaltrials.gov/show/NCT00388700
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

Israel

Key inclusion & exclusion criteria

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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Colorectal Cancer

Intervention(s)

Drug: GM-CT-01

Drug: 5-Fluorouracil, Leukovorin, bevacizumab

Primary Outcome(s)

Primary Outcomes: Assess the efficacy and safety of GM-CT-01 administered with 5-FU, LV, and Avastin® in the first-line treatment of unresectable, locally advanced, and/or metastatic CRC. [Time Frame: When 17 evaluable patients will complete the study]

Secondary Outcome(s)

To evaluate the safety of the DAVANAT®/5-FU, LV plus Avastin® regimen. [Time Frame: Throughout the study and when 17 evaluable patients will when complete the study]

Explore progression-free survival (PFS) and survival [Time Frame: When at least 17 evaluable patients complete the study]

Secondary ID(s)

DAVFU006

Source(s) of Monetary Support

Please refer to primary and secondary sponsors