Status:
COMPLETED
ARQ 501 in Combination With Gemcitabine in Subjects With Pancreatic Cancer
Lead Sponsor:
ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA)
Conditions:
Pancreatic Cancer
Adenocarcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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.
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 a...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2005
Trial Type :
INTERVENTIONAL
End Date :
January 1 2007
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT00102700
Start Date
January 1 2005
End Date
January 1 2007
Last Update
April 29 2009
Active Locations (15)
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1
University of South Alabama
Mobile, Alabama, United States, 36693
2
Moores UCSD Cancer Center
La Jolla, California, United States, 92093
3
Desert Hematology Oncology Medical Group, Inc.
Rancho Mirage, California, United States, 92270
4
Scripps Cancer Center
San Diego, California, United States, 92121