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

• Status: Completed
• Trial end date: 2012-08-01
• Target enrollment: 0
• Participant gender: All

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 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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Daiichi Sankyo Inc.; Daiichi Sankyo, Inc.
• Treatments: Albumin-Bound Paclitaxel; Carboplatin; Efatutazone; Paclitaxel

Criteria

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