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 |
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.
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
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Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
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3800 Reservoir Rd NW
Washington, District of Columbia 20007
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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