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ARQ 501 in Combination With G...

ARQ 501 in Combination With Gemcitabine in Subjects With Pancreatic Cancer

Last Updated: 2009-04-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-01-31

Study Completion Date

2007-01-31

Brief Summary

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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.

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Detailed Description

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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

Conditions

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Pancreatic Cancer Adenocarcinoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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ARQ 501 in combination with gemcitabine

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers