Status:
COMPLETED
Study of Carboplatin/Paclitaxel With or Without Investigational Drug (CS-7017) in Subjects With Metastatic Non-small Cell Lung Cancer
Lead Sponsor:
Daiichi Sankyo
Conditions:
Metastatic Non-small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 carb...
Eligibility Criteria
Inclusion
- 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
- 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 thiazolidinediones (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
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2012
Estimated Enrollment :
111 Patients enrolled
Trial Details
Trial ID
NCT00806286
Start Date
December 1 2008
End Date
August 1 2012
Last Update
May 13 2020
Active Locations (28)
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1
University Colorado Cancer Center
Aurora, Colorado, United States, 80045
2
Georgetown Univ. Medical Center
Washington D.C., District of Columbia, United States, 20007
3
Southern Illinois Hematology/Oncology
Centralia, Illinois, United States, 45042
4
Rush University Medical Center
Chicago, Illinois, United States, 60612