ARQ 501 in Combination With Gemcitabine in Subjects With Pancreatic Cancer

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT00102700

First Posted: February 2, 2005

Last Update Posted: April 29, 2009

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Information provided by:

ArQule

Tracking Information

First Submitted Date ^ICMJE

February 1, 2005

First Posted Date ^ICMJE

February 2, 2005

Last Update Posted Date

April 29, 2009

Start Date ^ICMJE

January 2005

Primary Completion Date

January 2007 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Document progression free survival after treatment with ARQ 501 and gemcitabine

Original Primary Outcome Measures ^ICMJE

Phase Ib: Define a maximum tolerated dose of ARQ 501 in combination with gemcitabine
Phase II: Document progression free survival after treatment with ARQ 501 and gemcitabine

Change History

Complete list of historical versions of study NCT00102700 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Document safety and efficacy of ARQ 501 in combination with gemcitabine

Original Secondary Outcome Measures ^ICMJE

Phase Ib: Safety and tolerability of ARQ 501 in combination with gemcitabine
Phase II: Document safety and efficacy of ARQ 501 in combination with gemcitabine

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

ARQ 501 in Combination With Gemcitabine in Subjects With Pancreatic Cancer

Official Title ^ICMJE

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

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 Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Condition ^ICMJE

Pancreatic Cancer
Adenocarcinoma

Intervention ^ICMJE

Drug: ARQ 501 in combination with gemcitabine

Study Arms

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

January 2007

Primary Completion Date

January 2007 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years and older (Adult, Senior)

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

United States

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT00102700

Other Study ID Numbers ^ICMJE

ARQ 501-212

Has Data Monitoring Committee

Not Provided

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

ArQule

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Not Provided

PRS Account

ArQule

Verification Date

April 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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