ARQ 501 in Combination With Gemcitabine in Subjects With Pancreatic Cancer

Sponsor

ArQule, Inc. (a wholly owned subsidiary of Merck Sharp and Dohme, a subsidiary of Merck & Co., Inc.) (Industry)

Overall Status

Completed

CT.gov ID

NCT00102700

Collaborator

(none)

Enrollment

Locations

Duration (Months)

4.4

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pancreatic Cancer Adenocarcinoma	Drug: ARQ 501 in combination with gemcitabine	Phase 2

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 Design

Study Type:

Interventional

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jan 1, 2005

Actual Primary Completion Date :

Jan 1, 2007

Actual Study Completion Date :

Jan 1, 2007

Outcome Measures

Primary Outcome Measures

Document progression free survival after treatment with ARQ 501 and gemcitabine []

Secondary Outcome Measures

Document safety and efficacy of ARQ 501 in combination with gemcitabine []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
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
5	VA San Diego Healthcare System	San Diego	California	United States	92161
6	University of Chicago Medical Center	Chicago	Illinois	United States	60637
7	University of Kentucky Medical Center	Lexington	Kentucky	United States	40536
8	Unversity of Kentucky Medical Center - Markey Center	Lexington	Kentucky	United States	40536
9	The Sidney Kimmel Comprehensive Cancer Center	Baltimore	Maryland	United States	21231
10	Massachusetts General Hospital	Boston	Massachusetts	United States	02114
11	Jeffrey Meyerhardt	Boston	Massachusetts	United States	02115
12	Jacobi Medical Center	Bronx	New York	United States	10461
13	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania	United States	15232
14	Baylor College of Medicine	Houston	Texas	United States	77030
15	Virginia Cancer Institute	Richmond	Virginia	United States	23230