ARQ 501 in Combination With Gemcitabine in Subjects With Pancreatic Cancer

Completed · Phase 2

Conditions studied: Pancreatic Cancer, Adenocarcinoma

In brief

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.

Key facts

Study ID

NCT00102700

Run by

ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA)

People needed

66

Starts

2005-01-01

Expected to finish

2007-01-01

Last updated by the study team

2009-04-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of South Alabama — Mobile, Alabama, United States
• Moores UCSD Cancer Center — La Jolla, California, United States
• Desert Hematology Oncology Medical Group, Inc. — Rancho Mirage, California, United States
• Scripps Cancer Center — San Diego, California, United States
• VA San Diego Healthcare System — San Diego, California, United States
• University of Chicago Medical Center — Chicago, Illinois, United States
• University of Kentucky Medical Center — Lexington, Kentucky, United States
• Unversity of Kentucky Medical Center - Markey Center — Lexington, Kentucky, United States
• The Sidney Kimmel Comprehensive Cancer Center — Baltimore, Maryland, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Jeffrey Meyerhardt — Boston, Massachusetts, United States
• Jacobi Medical Center — The Bronx, New York, United States
• University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States
• Baylor College of Medicine — Houston, Texas, United States
• Virginia Cancer Institute — Richmond, Virginia, United States

Full record on ClinicalTrials.gov

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