Study of Carboplatin/Paclitaxel With or Without Investigational Drug (CS-7017) in Subjects With Metastatic Non-small Cell Lung Cancer
Completed · Phase 2 · Has a placebo group
Conditions studied: Metastatic Non-small Cell Lung Cancer
In brief
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.
Key facts
- Study ID
- NCT00806286
- Run by
- Daiichi Sankyo
- People needed
- 111
- Starts
- 2008-12-01
- Expected to finish
- 2012-08-01
- Last updated by the study team
- 2020-05-13
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- University Colorado Cancer Center — Aurora, Colorado, United States
- Georgetown Univ. Medical Center — Washington D.C., District of Columbia, United States
- Southern Illinois Hematology/Oncology — Centralia, Illinois, United States
- Rush University Medical Center — Chicago, Illinois, United States
- Michiana Hematology-Oncology — South Bend, Indiana, United States
- Harbor View Cancer Center — Baltimore, Maryland, United States
- Massachusetts General Hospital — Boston, Massachusetts, United States
- Signal Point Clinical Research Center — Middletown, Ohio, United States
- Penn State Milton Hershey Cancer Center — Hershey, Pennsylvania, United States
- Eastern Virginia Medical School — Norfolk, Virginia, United States
- Kidwai Memorial Institute of Oncology — Bangalore, Karnataka, India
- Pentagon Research — Aundh, Maharashtra, India
- Shatabdi Super Specialty Hospital — Nashik, Mumbai Naka, India
- Hemato-Oncology Clinic, Vedanta — Gujarat, Navrangpura, Ahmedabad, India
- Meenakshi Mission Hospital — Madurai, Tamil Nadu, India
- Orchid Nursing Home — Kolkata, West Bengal, India
- Apollo Specialty Hospital — Chennai, India
- Ruby Hall Clinic — Pune, India
- Noble Hospital — Pune, India
- Oddzial Chemioterapii ZOZ MSWiA — Olsztyn, Poland
- Oddzial Onkologii Klinicznej z Pododdzialem Dziennej Chemioterapii — Poznan, Poland
- Specjalistyczny Szpital im. Prof. Alfresa Sokolowskiego — Szczecin, Poland
- Oncomed SRL — Timișoara, Judet Timis, Romania
- Spitalul Municipal Ploiesti — Ploieşti, Prahova, Romania
- Institutul Oncologic Prof. Dr. Alexandru Trestioreanu — Bucharest, Romania
Full record on ClinicalTrials.gov
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