A Study of ARRY-502 in Patients With Persistent Asthma



Status:Completed
Conditions:Asthma
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:18 - 70
Updated:3/30/2013
Start Date:March 2012
End Date:May 2013
Contact:Array BioPharma Clinical Trial Call Center
Phone:303-381-6604

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This is a Phase 2 study, involving a 6-week treatment period, designed to evaluate the
effectiveness of investigational study drug ARRY-502 in treating mild to moderate persistent
asthma, and to further evaluate the safety of the drug. Approximately 180 patients from the
US will be enrolled in this study.


Key Inclusion Criteria:

- Documented history of bronchial asthma diagnosed at least 6 months prior to study
start and prior to the age of 40 years.

- Body mass index (BMI) of 18 to 35 inclusive.

- An ACQ score of ≥ 1.5 at specified time points prior to first dose of study drug.

- A best prebronchodilator FEV1 of 60% to 85% of the predicted normal value and a
change in best postbronchodilator FEV1 of ≥ 12% and ≥ 200 mL at specified time points
prior to first dose of study drug.

- Additional criteria exist.

Key Exclusion Criteria:

- Evidence of aspirin-sensitive asthma.

- Pre-existing lung disease other than asthma.

- Clinically significant dermatologic, hematological, renal, endocrine, pulmonary
(other than asthma), gastrointestinal, cardiovascular, hepatic, neurologic,
ophthalmologic, musculoskeletal or immunologic disease (excepting allergic disease
and asthma) that is uncontrolled despite treatment or is likely in the opinion of the
Investigator to require a change in therapy during the study.

- Patients with any current or past history of cancer within 5 years prior to study
start except for treated basal cell or squamous cell carcinomas of the skin, ductal
carcinoma in situ of the breast or cervical carcinomas in situ.

- Any history of serious illness requiring hospitalization within 6 months prior to
study start.

- Known positive serology for the human immunodeficiency virus (HIV), hepatitis B
and/or active hepatitis C.

- A positive test for drugs or alcohol, unless the positive drug screen is associated
with a prescribed medication and is approved by the Medical Monitor.

- Smoking (tobacco or marijuana) within 6 months prior to study start and/or a smoking
history of > 10 packs/year.

- Blood donation of ≥ 1 pint (473 mL) within 8 weeks prior to the first dose of study
drug.

- Previous treatment with ARRY-502.

- Additional criteria exist.
We found this trial at
45
sites
Bozeman, Montana 59718
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Bozeman, MT
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2615 Lake Drive
Meredith, North Carolina 27607
919-881-0309
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Meredith, NC
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550 Deep Valley Drive Rolling Hills Estates
Palos Verdes, California 90274
310-265-1623
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Palos Verdes, CA
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6801 s Yosemite street
Southwest Arapahoe, Colorado 80112
303-773-9000
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Southwest Arapahoe, CO
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6565 S. Yale Ave.
Tulsa, Oklahoma 74136
918-392-4550
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Tulsa, OK
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Austin, Texas 78745
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Austin, TX
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Baltimore, Maryland 21236
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Baltimore, MD
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Bellevue, Nebraska 68123
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Bellevue, NE
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Canton, OH
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Centennial, Colorado 80112
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Cincinnati, Ohio 45231
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Cincinnati, OH
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Colorado Springs, Colorado 80909
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Colorado Springs, CO
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Dallas, TX
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Eagle, Idaho 83616
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Eagle, ID
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El Paso, Texas 79903
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El Paso, TX
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Fargo, North Dakota 58103
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Fargo, ND
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Greenfield, Wisconsin 53228
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Huntington Beach, California 92647
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Indianapolis, Indiana 46208
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Indianapolis, IN
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Kissimmee, Florida 34741
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Kissimmee, FL
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Lake Oswego, OR
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Los Angeles, CA
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Los Angeles, California 90025
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Los Angeles, CA
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Louisville, KY
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Madison, Wisconsin 53792
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Madison, WI
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Medford, OR
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Miami, Florida 33186
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Miami, FL
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Minneappolis, Minnesota 55402
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Mission Viejo, California 92691
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New Braunfels, Texas 78130
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Normal, Illinois 61761
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Normal, IL
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North Dartmouth, Massachusetts 02747
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North Dartmouth, MA
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Oklahoma City, Oklahoma 73120
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Oklahoma City, OK
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Oklahoma City, Oklahoma 73103
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Orlando, Florida 32806
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Pittsburgh, Pennsylvania 15213
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Pittsburgh, PA
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San Antonio, Texas 78229
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San Antonio, TX
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San Diego, California 92120
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San Diego, CA
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Seattle, Washington 98105
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Seattle, WA
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Skillman, New Jersey 08558
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Skillman, NJ
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Sylvania, OH
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Tallahassee, FL
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Wheat Ridge, Colorado 80033
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Winter Park, Florida 32789
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Winter Park, FL
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