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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


Phase 2
18 Years
N/A
Not Enrolling
Both
Colorectal Cancer

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Trial Information

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


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.


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

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.

Outcome Description:

To assess the clinical benefit of a regimen of GM-CT-01/5-FU, LV plus Avastin® when administered intravenously as a first-line treatment to patients with Stage III or IV ,advanced or metastatic CRC. Clinical activity will be assessed by determining the percentage of subjects exhibiting an objective response (complete response [CR]) plus partial response [PR]). Tumor response will be assessed following Response Evaluation by RECIST guidelines.

Outcome Time Frame:

When 17 evaluable patients will complete the study

Safety Issue:

Yes

Authority:

United States: Food and Drug Administration

Study ID:

DAVFU006

NCT ID:

NCT00388700

Start Date:

October 2006

Completion Date:

June 2009

Related Keywords:

  • Colorectal Cancer
  • Colorectal cancer, DAVANAT, colon cancer, 5-FU
  • Colorectal Neoplasms

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