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Sponsored by: |
AmpliMed Corporation |
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Information provided by: | AmpliMed Corporation |
ClinicalTrials.gov Identifier: | NCT00327327 |
AMP-004 is a Phase 1b dose escalation trial designed to evaluate the safety of the new drug imexon in combination with an approved drug, gemcitabine, for the treatment of patients with previously untreated pancreatic cancer. The treatment consists of dosing with both imexon and gemcitabine on days 1, 8, and 15 of each 28 day cycle. The study is designed to determine the highest doses of the two drugs that can be safely combined together.
Condition | Intervention | Phase |
---|---|---|
Pancreatic Adenocarcinoma |
Drug: imexon Drug: gemcitabine |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study |
Official Title: | A Phase 1 Trial of Amplimexon® (Imexon, Inj.) Plus Gemcitabine in Advanced, Previously Untreated Pancreatic Adenocarcinoma |
Estimated Enrollment: | 100 |
Study Start Date: | February 2004 |
Estimated Study Completion Date: | August 2008 |
Estimated Primary Completion Date: | May 2008 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Arizona | |
Arizona Clinical Research Center | |
Tucson, Arizona, United States, 85715 | |
United States, Florida | |
US Oncology Orlando, Cancer Centers of FL | |
Ocoee, Florida, United States, 34761 | |
United States, Indiana | |
US Oncology Indiana | |
Indianapolis, Indiana, United States, 46227 | |
United States, Michigan | |
Univ of Michigan | |
Ann Arbor, Michigan, United States, 48109 | |
United States, New York | |
US Oncology Albany, New York Oncology | |
Albany, New York, United States, 12208 | |
United States, Ohio | |
US Oncology Kettering | |
Kettering, Ohio, United States, 45409 | |
United States, Pennsylvania | |
Fox Chase Cancer Ctr. | |
Philadelphia, Pennsylvania, United States, 19111 | |
United States, Virginia | |
US Oncology, Virginia Oncology Assoc | |
Norfolk, Virginia, United States, 23502 | |
United States, Washington | |
US Oncology Northwest, Northwest Cancer Specialists | |
Vancouver, Washington, United States, 98684 |
Principal Investigator: | Mark Zalupski, MD | University of Michigan |
Principal Investigator: | Steven Cohen, MD | Fox Chase Cancer Center |
Responsible Party: | AmpliMed Corporation ( Evan Hersh, VP Medical Affairs ) |
Study ID Numbers: | AMP-004 |
Study First Received: | May 17, 2006 |
Last Updated: | June 13, 2008 |
ClinicalTrials.gov Identifier: | NCT00327327 |
Health Authority: | United States: Food and Drug Administration |
Gemcitabine Adenocarcinoma Neoplasms, Glandular and Epithelial Carcinoma |
Antimetabolites Anti-Infective Agents Neoplasms by Histologic Type Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs |
Enzyme Inhibitors Antiviral Agents Immunosuppressive Agents Pharmacologic Actions Neoplasms Radiation-Sensitizing Agents Therapeutic Uses |