Clinical trial NCT00102700: ARQ 501 in Combination With Gemcitabine in Subjects With Pancreatic Cancer
Official title: A Phase II Study of ARQ 501 in Combination With Gemcitabine in Adult Patients With Metastatic Pancreatic Adenocarcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pancreatic Cancer
Adenocarcinoma
Keywords: cancer
solid tumor
advanced solid tumor
pancreas
pancreatic cancer
cancer of the pancreas
Lead sponsor: ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA)
Sponsor class: INDUSTRY
First posted: 2005-02-02
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Eligibility 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.

Primary outcomes:
measure: Document progression free survival after treatment with ARQ 501 and gemcitabine
Secondary outcomes:
measure: Document safety and efficacy of ARQ 501 in combination with gemcitabine
Other outcomes:
Locations:
city: Mobile
country: United States
facility: University of South Alabama
state: Alabama
city: La Jolla
country: United States
facility: Moores UCSD Cancer Center
state: California
city: Rancho Mirage
country: United States
facility: Desert Hematology Oncology Medical Group, Inc.
state: California
city: San Diego
country: United States
facility: Scripps Cancer Center
state: California
city: San Diego
country: United States
facility: VA San Diego Healthcare System
state: California
city: Chicago
country: United States
facility: University of Chicago Medical Center
state: Illinois
city: Lexington
country: United States
facility: University of Kentucky Medical Center
state: Kentucky
city: Lexington
country: United States
facility: Unversity of Kentucky Medical Center - Markey Center
state: Kentucky
city: Baltimore
country: United States
facility: The Sidney Kimmel Comprehensive Cancer Center
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Jeffrey Meyerhardt
state: Massachusetts
city: Bronx
country: United States
facility: Jacobi Medical Center
state: New York
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: Richmond
country: United States
facility: Virginia Cancer Institute
state: Virginia
Study officials:
References: