ARQ 501 in Combination With Gemcitabine in Subjects With Pancreatic Cancer
Information source: ArQule
Information obtained from ClinicalTrials.gov on May 08, 2007
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pancreatic Cancer; Adenocarcinoma
Intervention: ARQ 501 in combination with gemcitabine (Drug)
Phase: Phase 2
Status: No longer recruiting
Sponsored by: ArQule
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.
Clinical Details
Official title:
A Phase II Study of ARQ 501 in Combination With Gemcitabine in Adult Patients With Metastatic Pancreatic Adenocarcinoma
Study design: Interventional, Treatment, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety/Efficacy Study
Primary outcome: Document progression free survival after treatment with ARQ 501 and gemcitabine
Secondary outcome: Document safety and efficacy of ARQ 501 in combination with gemcitabine
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
Eligibility
Minimum age: 18 Years.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
University of South Alabama, Mobile, Alabama 36693, United States
Desert Hematology Oncology Medical Group, Inc., Rancho Mirage, California 92270, United States
Moores UCSD Cancer Center, La Jolla, California 92093, United States
VA San Diego Healthcare System, San Diego, California 92161, United States
Scripps Cancer Center, San Diego, California 92121, United States
University of Chicago Medical Center, Chicago, Illinois 60637, United States
University of Kentucky Medical Center, Lexington, Kentucky 40536, United States
Unversity of Kentucky Medical Center - Markey Center, Lexington, Kentucky 40536, United States
The Sidney Kimmel Comprehensive Cancer Center, Baltimore, Maryland 21231, United States
Massachusetts General Hospital, Boston, Massachusetts 02114, United States
Jeffrey Meyerhardt, Boston, Massachusetts 02115, United States
Jacobi Medical Center, Bronx, New York 10461, United States
University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania 15232, United States
Baylor College of Medicine, Houston, Texas 77030, United States
Virginia Cancer Institute, Richmond, Virginia 23230, United States
Additional Information
Starting date:
January 2005
Last updated: February 1, 2007
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