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| Sponsor: | University of Chicago |
|---|---|
| Collaborator: |
Bayer |
| Information provided by: | University of Chicago |
| ClinicalTrials.gov Identifier: | NCT00619242 |
Purpose
To determine whether sorafenib is able to change pre-cancerous cells in a way that we believe is important in the progression of cancer.
| Condition | Intervention |
|---|---|
|
Esophageal Cancer |
Drug: sorafenib |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Pilot Study of the Effect of Sorafenib on Molecular Biomarkers in Barrett's Esophagus With High Grade Dysplasia |
| Estimated Enrollment: | 15 |
| Study Start Date: | June 2006 |
| Estimated Study Completion Date: | May 2011 |
| Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: sorafenib |
Drug: sorafenib
2 tablets with water by mouth twice a day for two weeks.
Other Name: Sorafenib
|
To characterize the effects of sorafenib on specific molecular markers in patients with Barrett's esophagus and high grade intraepithelial neoplasia (HGIN) or carcinoma in situ (CIS).
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients with the following other concurrent illness are excluded:
Patients must have adequate organ and marrow function as defined below:
Exclusion Criteria:
A patient will be withdrawn from the study if any of the following events occur while on therapy:
Contacts and Locations| Contact: Ezra Cohen, MD | 773/702-4137 | ecohen@medicine.bsd.uchicago.edu |
| United States, Illinois | |
| University of Chicago | Recruiting |
| Chicago, Illinois, United States, 60637 | |
| Contact: Ezra Cohen, MD 773-702-4137 ecohen@medicine.bsd.uchicago.edu | |
| Principal Investigator: Ezra Cohen, MD | |
| Principal Investigator: | Ezra Cohen, MD | University of Chicago |
More Information
| Responsible Party: | Ezra Cohen, MD, University of Chicago |
| ClinicalTrials.gov Identifier: | NCT00619242 History of Changes |
| Other Study ID Numbers: | 14374B |
| Study First Received: | February 6, 2008 |
| Last Updated: | February 13, 2009 |
| Health Authority: | United States: Food and Drug Administration |
|
Esophageal cancer |
|
Barrett Esophagus Esophageal Diseases Esophageal Neoplasms Digestive System Abnormalities Digestive System Diseases Gastrointestinal Diseases Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site |
Neoplasms Head and Neck Neoplasms Sorafenib Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |