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Sponsored by: |
ArQule |
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Information provided by: | ArQule |
ClinicalTrials.gov Identifier: | NCT00102700 |
The study will document the safety and efficacy of the combination of ARQ 501 and gemcitabine in patients with treatment-naïve, unresectable, metastatic pancreatic adenocarcinoma.
Condition | Intervention | Phase |
---|---|---|
Pancreatic Cancer Adenocarcinoma |
Drug: ARQ 501 in combination with gemcitabine |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase II Study of ARQ 501 in Combination With Gemcitabine in Adult Patients With Metastatic Pancreatic Adenocarcinoma |
Estimated Enrollment: | 66 |
Study Start Date: | January 2005 |
This is a single-arm, non-randomized study of ARQ 501 in combination with gemcitabine in adult patients with treatment-naïve, unresectable, metastatic pancreatic adenocarcinoma. The study objectives are:
Primary Objective:
Secondary Objectives:
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Alabama | |
University of South Alabama | |
Mobile, Alabama, United States, 36693 | |
United States, California | |
Desert Hematology Oncology Medical Group, Inc. | |
Rancho Mirage, California, United States, 92270 | |
Moores UCSD Cancer Center | |
La Jolla, California, United States, 92093 | |
VA San Diego Healthcare System | |
San Diego, California, United States, 92161 | |
Scripps Cancer Center | |
San Diego, California, United States, 92121 | |
United States, Illinois | |
University of Chicago Medical Center | |
Chicago, Illinois, United States, 60637 | |
United States, Kentucky | |
University of Kentucky Medical Center | |
Lexington, Kentucky, United States, 40536 | |
Unversity of Kentucky Medical Center - Markey Center | |
Lexington, Kentucky, United States, 40536 | |
United States, Maryland | |
The Sidney Kimmel Comprehensive Cancer Center | |
Baltimore, Maryland, United States, 21231 | |
United States, Massachusetts | |
Massachusetts General Hospital | |
Boston, Massachusetts, United States, 02114 | |
Jeffrey Meyerhardt | |
Boston, Massachusetts, United States, 02115 | |
United States, New York | |
Jacobi Medical Center | |
Bronx, New York, United States, 10461 | |
United States, Pennsylvania | |
University of Pittsburgh Medical Center | |
Pittsburgh, Pennsylvania, United States, 15232 | |
United States, Texas | |
Baylor College of Medicine | |
Houston, Texas, United States, 77030 | |
United States, Virginia | |
Virginia Cancer Institute | |
Richmond, Virginia, United States, 23230 |
Study ID Numbers: | ARQ 501-212 |
Study First Received: | February 1, 2005 |
Last Updated: | January 8, 2009 |
ClinicalTrials.gov Identifier: | NCT00102700 |
Health Authority: | United States: Food and Drug Administration |
cancer solid tumor advanced solid tumor |
pancreas pancreatic cancer cancer of the pancreas |
Digestive System Neoplasms Pancreatic Neoplasms Endocrine System Diseases Pancrelipase Carcinoma Digestive System Diseases Beta-lapachone |
Gastrointestinal Neoplasms Pancreatic Diseases Endocrinopathy Adenocarcinoma Gemcitabine Neoplasms, Glandular and Epithelial Endocrine Gland Neoplasms |
Antimetabolites Anti-Infective Agents Neoplasms by Histologic Type Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs |
Enzyme Inhibitors Antiviral Agents Immunosuppressive Agents Pharmacologic Actions Neoplasms Neoplasms by Site Radiation-Sensitizing Agents Therapeutic Uses |