Randomized, Double-Blind, Multicenter, Study Comparing Veliparib Plus Carboplatin and Paclitaxel Versus Placebo Plus Carboplatin and Paclitaxel in Previously Untreated Advanced or Metastatic Squamous Non-Small Cell Lung Cancer



Status:Active, not recruiting
Conditions:Lung Cancer, Lung Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - 99
Updated:3/20/2019
Start Date:April 10, 2014
End Date:July 15, 2019

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Randomized, Double-Blind, Multicenter, Phase 3 Study Comparing Veliparib Plus Carboplatin and Paclitaxel Versus Placebo Plus Carboplatin and Paclitaxel in Previously Untreated Advanced or Metastatic Squamous Non-Small Cell Lung Cancer (NSCLC)

This is a 2 arm Phase 3 study to evaluate the safety and efficacy of the addition of
veliparib plus carboplatin and paclitaxel versus the addition of placebo plus carboplatin and
paclitaxel in subjects with advanced or metastatic squamous NSCLC.


Inclusion Criteria:

1. Life expectancy > 12 weeks

2. Subject must have cytologically or histologically confirmed squamous NSCLC.

3. Subject must have advanced or metastatic squamous NSCLC that is not amenable to
surgical resection or radiation with curative intent at time of study Screening.

4. Subjects with recurrent squamous NSCLC after surgical treatment that is not amenable
to surgical resection or radiation with curative intent are eligible.

5. Subject must have at least 1 unidimensional measurable NSCLC lesion on a Computerized
Tomography (CT) scan as defined by Response Evaluation Criteria In Solid Tumors
(RECIST - version 1.1).

Exclusion Criteria:

1. Subject has a known hypersensitivity to paclitaxel or to other drugs formulated with
polyethoxylated castor oil (Cremophor).

2. Subject has a known hypersensitivity to platinum compounds.

3. Subject has peripheral neuropathy >= grade 2.

4. Subject has non-squamous NSCLC, or a known Epidermal Growth Factor Receptor (EGFR)
mutation of exon 19 deletion or L858R mutation in exon 21, or a known Anaplastic
Lymphoma Kinase (ALK) gene rearrangement.

5. Subject has received prior cytotoxic chemotherapy (including definitive
chemoradiotherapy) for NSCLC, except for adjuvant or neoadjuvant therapy.
We found this trial at
40
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Arlington Heights, Illinois 60005
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Atlanta, Georgia 30322
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Atlanta, GA
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Aurora, CO
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Austin, TX
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4101 James Casey Street
Austin, Texas 78745
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Boise, ID
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Burlington, VT
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4875 Higbee Avenue Northwest
Canton, Ohio 44718
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Canton, OH
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Coon Rapids, MN
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Dallas, TX
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Dallas, TX
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Evanston, IL
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4725 North Federal Highway
Fort Lauderdale, Florida 33308
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Fort Lauderdale, FL
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Gainesville, Florida 32608
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Gainesville, FL
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7710 Wolf River Circle
Germantown, Tennessee 38138
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Germantown, TN
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Goshen, IN
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Hackensack, New Jersey 07601
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Hackensack, NJ
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1 Ingalls Drive
Harvey, Illinois 60426
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Harvey, IL
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200 Medical Center Drive
Hazard, Kentucky 41701
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Hazard, KY
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500 University Drive
Hershey, Pennsylvania 17033
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Hershey, PA
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Houston, TX
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Houston, Texas 77030
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Houston, TX
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Indianapolis, Indiana 46237
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Indianapolis, IN
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7015 A C Skinner Parkway
Jacksonville, Florida 32256
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Jacksonville, FL
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Jonesboro, Arkansas 72401
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Jonesboro, AR
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Lansing, Michigan 48912
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Lansing, MI
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Las Vegas, NV
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1 Medical Center Drive
Lebanon, New Hampshire 03766
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Lebanon, NH
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4004 Pioneer Woods Drive
Lincoln, Nebraska 68506
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Lincoln, NE
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Lincoln, Nebraska 68510
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Lincoln, NE
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Los Angeles, California 90017
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Los Angeles, CA
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910 East 26th Street
Minneapolis, Minnesota 55404
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Minneapolis, MN
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Norfolk, VA
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3550 Northeast Loop 286
Paris, Texas 75460
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Paris, TX
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Portland, OR
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2501 Northeast 134th Street
Vancouver, Washington 98684
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Vancouver, WA
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1700 West Highway 6
Waco, Texas 76712
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Waco, TX
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West Bloomfield, Michigan 48322
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West Bloomfield, MI
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Wollongong, New South Wales
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Wollongong,
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Zion, IL
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