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A Study of ARRY-334543 and Gemcitabine in Patients With Advanced Cancer and Pancreatic Cancer

NCT ID: NCT00862524

Last Updated: 2012-10-04

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

PHASE1/PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Study Completion Date

2011-02-28

Brief Summary

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This is a 2-phase study during which patients with advanced/metastatic solid tumors will receive investigational study drug ARRY-334543 and gemcitabine.

The study has 2 parts. In the first part of the study, Phase 1, patients with advanced/metastatic solid tumors will receive increasing doses of study drug in combination with gemcitabine in order to achieve the highest dose of study drug possible that will not cause unacceptable side effects. Patients will be followed to see what side effects the combination causes and what effectiveness the combination has, if any, in treating the cancer. Approximately 24 patients from the US will be enrolled in Part 1 (Completed).

In the second part of the study, Phase 2, patients with metastatic pancreatic cancer will receive the best dose of study drug, in combination with gemcitabine, determined from the first part of the study and will be followed to see what side effects the combination causes and what effectiveness the combination has, if any, in treating the cancer. Approximately 42 patients from the US will be enrolled in Part 2 (Withdrawn).

Detailed Description

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Conditions

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Advanced Cancer Pancreatic Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ARRY-334543 + gemcitabine

Group Type EXPERIMENTAL

ARRY-334543, EGFR/ErbB2 inhibitor; oral

Intervention Type DRUG

multiple dose, escalating

Gemcitabine, nucleoside analogue; intravenous

Intervention Type DRUG

multiple dose, single schedule

Interventions

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ARRY-334543, EGFR/ErbB2 inhibitor; oral

multiple dose, escalating

Intervention Type DRUG

Gemcitabine, nucleoside analogue; intravenous

multiple dose, single schedule

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Histologically or cytologically confirmed diagnosis of a solid tumor suitable for treatment with gemcitabine.
* No more than 3 prior anticancer regimens for advanced disease.
* Measurable or evaluable, nonmeasurable disease.
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
* Able to take and retain oral medications.
* Additional criteria exist.

Exclusion Criteria

* Uncontrolled or symptomatic brain metastases (if a patient has brain metastases and is on steroids, the steroid dose must have been stable for at least 30 days).
* Treatment with prior chemotherapy within 21 days of first dose of study drug.
* Requiring IV alimentation.
* Pregnancy or lactation.
* Known positive serology for the human immunodeficiency virus (HIV), hepatitis B and/or hepatitis C.
* History of being unable to tolerate gemcitabine or any of its components.
* Additional criteria exist.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Array BioPharma

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Pinnacle Oncology/Hematology

Phoenix, Arizona, United States

Site Status

Premiere Oncology

Santa Monica, California, United States

Site Status

University of Colorado Health Sciences Center

Aurora, Colorado, United States

Site Status

Partners, Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Partners, Dana Farber

Boston, Massachusetts, United States

Site Status

Sarah Cannon Research Center

Nashville, Tennessee, United States

Site Status

Countries

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United States

Other Identifiers

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ARRAY-543-206

Identifier Type: -

Identifier Source: org_study_id