ARQ 501 in Combination With Gemcitabine in Subjects With Pancreatic Cancer

Phase 2

Completed

• Conditions: Pancreatic Cancer; Adenocarcinoma

• Registration Number: NCT00102700
• Lead Sponsor: ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA)

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 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

Study Timeline

• Study Start: 2005-01
• Study First Submitted: 2005-02-01
• Study First Submitted QC: 2005-02-01
• Study First Posted: 2005-02-02
• Primary Completion: 2007-01
• Study Completion: 2007-01
• Status Verified: 2009-04
• Last Update Submitted: 2009-04-28
• Last Update Posted: 2009-04-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Document progression free survival after treatment with ARQ 501 and gemcitabine

Secondary Outcome Measures

Name	Time	Method
Document safety and efficacy of ARQ 501 in combination with gemcitabine

Trial Locations

Locations (15)

Desert Hematology Oncology Medical Group, Inc.; 🇺🇸 Rancho Mirage, California, United States

Baylor College of Medicine; 🇺🇸 Houston, Texas, United States

University of Pittsburgh Medical Center; 🇺🇸 Pittsburgh, Pennsylvania, United States

Scripps Cancer Center; 🇺🇸 San Diego, California, United States

Jacobi Medical Center; 🇺🇸 Bronx, New York, United States

Jeffrey Meyerhardt; 🇺🇸 Boston, Massachusetts, United States

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

University of Kentucky Medical Center; 🇺🇸 Lexington, Kentucky, United States

Virginia Cancer Institute; 🇺🇸 Richmond, Virginia, United States

University of South Alabama; 🇺🇸 Mobile, Alabama, United States

Moores UCSD Cancer Center; 🇺🇸 La Jolla, California, United States

The Sidney Kimmel Comprehensive Cancer Center; 🇺🇸 Baltimore, Maryland, United States

VA San Diego Healthcare System; 🇺🇸 San Diego, California, United States

University of Chicago Medical Center; 🇺🇸 Chicago, Illinois, United States

Unversity of Kentucky Medical Center - Markey Center; 🇺🇸 Lexington, Kentucky, United States