ARQ 501 in Combination With Gemcitabine in Subjects With Pancreatic Cancer

Pancreatic Cancer Clinical Trial

Official title:

A Phase II Study of ARQ 501 in Combination With Gemcitabine in Adult Patients With Metastatic Pancreatic Adenocarcinoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00102700
• Other study ID #: ARQ 501-212
• Status: Completed
• Phase: Phase 2
• First received: February 1, 2005
• Last updated: April 28, 2009
• Start date: January 2005
• Est. completion date: January 2007

Study information

• Verified date: April 2009
• Source: ArQule
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: January 2007
• Est. primary completion date: January 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adenocarcinoma
• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Drug:
• ARQ 501 in combination with gemcitabine

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
ArQule

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Document progression free survival after treatment with ARQ 501 and gemcitabine
Secondary	Document safety and efficacy of ARQ 501 in combination with gemcitabine