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ARQ 501 in Combination With Gemcitabine in Subjects With Pancreatic Cancer

This study has been completed.
Information provided by:
ArQule Identifier:
First received: February 1, 2005
Last updated: April 28, 2009
Last verified: April 2009
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 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of ARQ 501 in Combination With Gemcitabine in Adult Patients With Metastatic Pancreatic Adenocarcinoma

Resource links provided by NLM:

Further study details as provided by ArQule:

Primary Outcome Measures:
  • Document progression free survival after treatment with ARQ 501 and gemcitabine

Secondary Outcome Measures:
  • Document safety and efficacy of ARQ 501 in combination with gemcitabine

Estimated Enrollment: 66
Study Start Date: January 2005
Study Completion Date: January 2007
Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)
Detailed Description:

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:

  • Assess the overall response rate (ORR) of patients treated with ARQ 501 in combination with gemcitabine.

Secondary Objectives:

  • Determine time to tumor progression (TTP) of patients treated with ARQ 501 in combination with gemcitabine
  • Further characterize the safety of ARQ 501 in combination with gemcitabine

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Have a pathologically confirmed diagnosis of unresectable, metastatic pancreatic adenocarcinoma
  • Be treatment-naïve.
  • Have measurable disease per RECIST Criteria.
  • Be ≥18 years old.
  • Have a Karnofsky Performance Status (KPS) of ≥70%.
  • Have an estimated life expectancy of ≥12 weeks.
  • Be male or a non-pregnant, non-lactating female patient. Patients who are fertile agree to use an effective barrier method of birth control (e.g., latex condom, diaphragm, or cervical cap) to avoid pregnancy.
  • Have a negative serum or urine pregnancy test within 7 days prior to the first dose of study drug (if patient is a female of childbearing potential).
  • Sign a written informed consent form.
  • Have adequate organ function as indicated by acceptable laboratory values obtained within 7 days prior to the first dose of study drug.

Exclusion Criteria:

  • Have received any prior therapy for the treatment of their pancreatic malignancy (including chemotherapy, immunotherapy, vaccines, monoclonal antibodies, major surgery, or irradiation, whether conventional or investigational).
  • Have an active, uncontrolled systemic infection considered opportunistic, life threatening or clinically significant at the time of treatment.
  • Are pregnant or lactating.
  • Have a psychiatric disorder(s) that would interfere with consent, study participation, or follow-up.
  • Have any other severe concurrent disease, which, in the judgment of the investigator, would make the patient inappropriate for entry into this study.
  • Have symptomatic or untreated central nervous system (CNS) metastases.
  • Have a known hypersensitivity to gemcitabine.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00102700

United States, Alabama
University of South Alabama
Mobile, Alabama, United States, 36693
United States, California
Moores UCSD Cancer Center
La Jolla, California, United States, 92093
Desert Hematology Oncology Medical Group, Inc.
Rancho Mirage, California, United States, 92270
Scripps Cancer Center
San Diego, California, United States, 92121
VA San Diego Healthcare System
San Diego, California, United States, 92161
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
Sponsors and Collaborators
  More Information Identifier: NCT00102700     History of Changes
Other Study ID Numbers: ARQ 501-212
Study First Received: February 1, 2005
Last Updated: April 28, 2009

Keywords provided by ArQule:
solid tumor
advanced solid tumor
pancreatic cancer
cancer of the pancreas

Additional relevant MeSH terms:
Pancreatic Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Anti-Retroviral Agents processed this record on September 20, 2017