Study of Carboplatin/Paclitaxel With or Without Investigational Drug (CS-7017) in 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.
Checked against the public recordLast updated May 13, 2020 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 2
- Sponsor
- Daiichi Sankyo
- Interventions being studied
- Drug: CS7017 tablets; Drug: Paclitaxel; Drug: Carboplatin; Drug: Placebo Tablets
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
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 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
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- University Colorado Cancer CenterAurora, Colorado
- Georgetown Univ. Medical CenterWashington D.C., District of Columbia
- Southern Illinois Hematology/OncologyCentralia, Illinois
- Rush University Medical CenterChicago, Illinois
- Michiana Hematology-OncologySouth Bend, Indiana
- Harbor View Cancer CenterBaltimore, Maryland
- Massachusetts General HospitalBoston, Massachusetts
- Signal Point Clinical Research CenterMiddletown, Ohio
- Penn State Milton Hershey Cancer CenterHershey, Pennsylvania
- Eastern Virginia Medical SchoolNorfolk, Virginia
- Kidwai Memorial Institute of OncologyBangalore, Karnataka
- Pentagon ResearchAundh, Maharashtra
Source and freshness
Processed from ClinicalTrials.gov. Last public update: May 13, 2020. Always confirm current availability with the study team.