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

Purpose

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 Approximately 42 patients from the US will be enrolled in Part 2 (Withdrawn).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	Intervention	Phase
Advanced Cancer Pancreatic Cancer	Drug: ARRY-334543, EGFR/ErbB2 inhibitor; oral Drug: Gemcitabine, nucleoside analogue; intravenous	Phase 1 Phase 2

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Cancer Pancreatic Cancer

Drug Information available for: Gemcitabine Gemcitabine hydrochloride

U.S. FDA Resources

Further study details as provided by Array BioPharma:

Primary Outcome Measures:

Establish the maximum tolerated dose (MTD) of study drug in combination with gemcitabine. [ Time Frame: Part 1 ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: Yes ]
Characterize the pharmacokinetics (PK) of study drug, gemcitabine and a gemcitabine metabolite. [ Time Frame: Part 1 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Assess the efficacy of the study drug in combination with gemcitabine in terms of tumor response. [ Time Frame: Part 1 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: Yes ]

Enrollment:	20
Study Start Date:	March 2009
Study Completion Date:	February 2011
Primary Completion Date:	February 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: ARRY-334543 + gemcitabine	Drug: ARRY-334543, EGFR/ErbB2 inhibitor; oral multiple dose, escalating Drug: Gemcitabine, nucleoside analogue; intravenous multiple dose, single schedule

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00862524

Locations

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

No publications provided

Responsible Party:	Array BioPharma
ClinicalTrials.gov Identifier:	NCT00862524 History of Changes
Other Study ID Numbers:	ARRAY-543-206
Study First Received:	March 16, 2009
Last Updated:	September 28, 2012
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Pancreatic Neoplasms
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Gemcitabine
Antimetabolites, Antineoplastic
Antimetabolites

Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on May 23, 2013