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
Baltimore, Maryland 21236
2308
mi
from 91732
Baltimore, MD
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2615 Lake Drive
Meredith, North Carolina 27607
919-881-0309
2214
mi
from 91732
Meredith, NC
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550 Deep Valley Drive Rolling Hills Estates
Palos Verdes, California 90274
310-265-1623
29
mi
from 91732
Palos Verdes, CA
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6801 s Yosemite street
Southwest Arapahoe, Colorado 80112
303-773-9000
818
mi
from 91732
Southwest Arapahoe, CO
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6565 S. Yale Ave.
Tulsa, Oklahoma 74136
918-392-4550
1254
mi
from 91732
Tulsa, OK
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Austin, Texas 78745
1212
mi
from 91732
Austin, TX
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Bellevue, Nebraska 68123
1300
mi
from 91732
Bellevue, NE
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Bozeman, Montana 59718
882
mi
from 91732
Bozeman, MT
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2047
mi
from 91732
Canton, OH
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Centennial, Colorado 80112
818
mi
from 91732
Centennial, CO
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Cincinnati, Ohio 45231
1880
mi
from 91732
Cincinnati, OH
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Colorado Springs, Colorado 80909
802
mi
from 91732
Colorado Springs, CO
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1226
mi
from 91732
Dallas, TX
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Eagle, Idaho 83616
670
mi
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Eagle, ID
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El Paso, Texas 79903
688
mi
from 91732
El Paso, TX
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Fargo, North Dakota 58103
1414
mi
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Fargo, ND
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Greenfield, Wisconsin 53228
1723
mi
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Greenfield, WI
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Huntington Beach, California 92647
27
mi
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Huntington Beach, CA
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Indianapolis, Indiana 46208
1793
mi
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Indianapolis, IN
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Kissimmee, Florida 34741
2188
mi
from 91732
Kissimmee, FL
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822
mi
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Lake Oswego, OR
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24
mi
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Los Angeles, CA
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13
mi
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Los Angeles, CA
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Los Angeles, California 90025
13
mi
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Los Angeles, CA
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1812
mi
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Louisville, KY
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Madison, Wisconsin 53792
1656
mi
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Madison, WI
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627
mi
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Medford, OR
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Miami, Florida 33186
2321
mi
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Miami, FL
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Minneappolis, Minnesota 55402
1509
mi
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Minneappolis, MN
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Mission Viejo, California 92691
37
mi
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Mission Viejo, CA
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New Braunfels, Texas 78130
1204
mi
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New Braunfels, TX
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Normal, Illinois 61761
1647
mi
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Normal, IL
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North Dartmouth, Massachusetts 02747
2585
mi
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North Dartmouth, MA
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Oklahoma City, Oklahoma 73120
1162
mi
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Oklahoma City, OK
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Oklahoma City, Oklahoma 73103
1165
mi
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Oklahoma City, OK
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Orlando, Florida 32806
2185
mi
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Orlando, FL
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Pittsburgh, Pennsylvania 15213
2119
mi
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Pittsburgh, PA
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San Antonio, Texas 78229
1182
mi
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San Antonio, TX
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San Diego, California 92120
105
mi
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San Diego, CA
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Seattle, Washington 98105
964
mi
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Seattle, WA
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Skillman, New Jersey 08558
2397
mi
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Skillman, NJ
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1929
mi
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Sylvania, OH
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1977
mi
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Tallahassee, FL
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Wheat Ridge, Colorado 80033
814
mi
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Wheat Ridge, CO
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Winter Park, Florida 32789
2184
mi
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Winter Park, FL
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