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

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.
 
ClinicalTrials.gov Identifier: NCT00862524
Recruitment Status : Completed
First Posted : March 17, 2009
Last Update Posted : October 4, 2012
Sponsor:
Information provided by (Responsible Party):
Array BioPharma

Study Description
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Brief Summary:

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 Approximately 42 patients from the US will be enrolled in Part 2 (Withdrawn).


Condition or disease Intervention/treatment Phase
Advanced Cancer Pancreatic Cancer Drug: ARRY-334543, EGFR/ErbB2 inhibitor; oral Drug: Gemcitabine, nucleoside analogue; intravenous Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : March 2009
Actual Primary Completion Date : February 2011
Actual Study Completion Date : February 2011

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: ARRY-334543 + gemcitabine Drug: ARRY-334543, EGFR/ErbB2 inhibitor; oral
multiple dose, escalating

Drug: Gemcitabine, nucleoside analogue; intravenous
multiple dose, single schedule


Outcome Measures
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Primary Outcome Measures :
  1. Establish the maximum tolerated dose (MTD) of study drug in combination with gemcitabine. [ Time Frame: Part 1 ]
  2. Characterize the safety profile of study drug in combination with gemcitabine in terms of adverse events, clinical laboratory tests and electrocardiograms. [ Time Frame: Part 1 ]
  3. Characterize the pharmacokinetics (PK) of study drug, gemcitabine and a gemcitabine metabolite. [ Time Frame: Part 1 ]
  4. Assess the efficacy of the study drug in combination with gemcitabine in terms of progression-free survival (PFS) at 16 weeks. [ Time Frame: Part 2 ]

Secondary Outcome Measures :
  1. Assess the efficacy of the study drug in combination with gemcitabine in terms of tumor response. [ Time Frame: Part 1 ]
  2. Characterize the safety profile of study drug in combination with gemcitabine in terms of adverse events, clinical laboratory tests and electrocardiograms. [ Time Frame: Part 2 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria (Part 1):

  • 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.

Key Exclusion Criteria (Part 1):

  • 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00862524


Locations
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United States, Arizona
Pinnacle Oncology/Hematology
Phoenix, Arizona, United States, 85258
United States, California
Premiere Oncology
Santa Monica, California, United States, 90404-2111
United States, Colorado
University of Colorado Health Sciences Center
Aurora, Colorado, United States, 80045
United States, Massachusetts
Partners, Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Partners, Dana Farber
Boston, Massachusetts, United States, 02115
United States, Tennessee
Sarah Cannon Research Center
Nashville, Tennessee, United States, 37203
Sponsors and Collaborators
Array BioPharma
More Information
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Responsible Party: Array BioPharma
ClinicalTrials.gov Identifier: NCT00862524    
Other Study ID Numbers: ARRAY-543-206
First Posted: March 17, 2009    Key Record Dates
Last Update Posted: October 4, 2012
Last Verified: September 2012
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Gemcitabine
Antimetabolites, Antineoplastic
 Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs