Study of Carboplatin/Paclitaxel With or Without Investigational Drug (CS-7017) in Subjects With Metastatic Non-small Cell Lung Cancer



Status:Completed
Conditions:Lung Cancer, Lung Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:12/29/2018
Start Date:December 2008
End Date:August 2012

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Phase 2 Randomized Study of Carboplatin/Paclitaxel With or Without CS-7017 in Chemotherapy-Naïve Subjects With Metastatic Non-Small Cell Lung Cancer

The study has a safety and a Phase 2 portion. In the safety portion of the study, subjects
with metastatic non-small cell lung cancer will be treated with study drug (CS-7017) in
combination with carboplatin and paclitaxel to evaluate safety. In the Phase 2 portion of the
study, subjects will receive study drug (CS-7017) or placebo in combination with carboplatin
and paclitaxel to evaluate effectiveness and safety. The study will find out if adding
CS-7017 to carboplatin and paclitaxel will be safe and improve progression free survival in
subjects with metastatic non-small cell lung cancer.


Inclusion Criteria:

- Histologically or cytologically confirmed metastatic (stage IV) NSCLC with no
significant pleural effusion or pleural involvement from the tumor

- Age greater than or equal to 18 years

- Adequate organ and bone marrow function

Exclusion Criteria:

- Any prior systemic therapy for NSCLC

- Major surgical procedure or other investigational agents within 4 weeks before study
enrollment

- Need for concomitant use of other thiazolidinediones during the study

- History of any of the following conditions within 6 months prior to initiating study
treatment: Diabetes mellitus requiring treatment with insulin or sulfonylureas or TZDs
agents; Myocardia infarction with significant impairment of cardia function;
Malabsorption syndrome, chronic diarrhea, inflammatory bowel disease or partial bowel
obstruction;

- Clinically active brain metastases, uncontrolled seizure disorder; spinal cord
compression or carcinomatous meningitis
We found this trial at
11
sites
3800 Reservoir Rd NW
Washington, District of Columbia 20007
(202) 687-7695
Georgetown University Medical Center Georgetown University Medical Center is committed to excellence in research, education...
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
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Boston, MA
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Norfolk, Virginia 23507
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Norfolk, VA
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Aurora, Colorado 80045
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Aurora, CO
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Baltimore, Maryland 21225
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Baltimore, MD
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Bangalore, Karnataka 56002
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Bangalore,
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Centralia, Illinois 62801
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Centralia, IL
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1653 W. Congress Parkway
Chicago, Illinois 60612
(312) 942-5000
Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
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Chicago, IL
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Hershey, Pennsylvania 17033
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Hershey, PA
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Middletown, OH
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South Bend, Indiana 46628
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South Bend, IN
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