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Effect of Metformin on Biomarkers of Colorectal Tumor Cell Growth

NCT01632020 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2016-07-11

Study results available
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Summary

The purpose of this study is to investigate the effects of short term oral Metformin therapy on biomarkers for tumor growth in subjects with newly diagnosed colon or rectal adenocarcinoma.

It is hypothesized that there are independent actions of Metformin on the outcome of subjects with colorectal cancer (CRC). Also hypothesized is that metformin effects on CRC cell growth will correlate with this drug's effects on markers mentioned above, because the markers are closely related to tumor growth and metastases.

Conditions

  • Colorectal Neoplasms

Interventions

DRUG

Placebo

2 capsules by mouth twice daily; minimum of 10 days, maximum of 21 days

DRUG

Metformin

850 mg (2 capsules) by mouth twice daily; minimum of 10 days, maximum of 21 days

Sponsors & Collaborators

  • University of Arkansas

    lead OTHER

Principal Investigators

  • Rangaswamy Govindarajan, MD · University of Arkansas

  • Frank Simmen, PhD · University of Arkansas

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-08-31
Primary Completion
2015-01-31
Completion
2015-01-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01632020 on ClinicalTrials.gov