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

Information source: Galectin Therapeutics Inc.
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Colorectal Cancer

Intervention: GM-CT-01 (Drug); 5-Fluorouracil, Leukovorin, bevacizumab (Drug)

Phase: Phase 2

Status: Terminated

Sponsored by: Galectin Therapeutics Inc.

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 treating colorectal cancer in patients unable to tolerate intensive chemotherapy.

Clinical Details

Official 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

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: 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.

Secondary outcome:

To evaluate the safety of the DAVANAT®/5-FU, LV plus Avastin® regimen.

Explore progression-free survival (PFS) and survival

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 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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

Rambam Medical Center, Haifa 31096, Israel

Kaplan MC, Rechovot, Israel

Sheba MC, Tel Hashomer 52621, Israel

Sourasky Medical Center, Tel-Aviv 64239, Israel

Additional Information

Starting date: October 2006
Last updated: August 13, 2014

Page last updated: August 20, 2015

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