NCT00806286

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

Phase 2 Randomized Study of Carboplatin/Paclitaxel With or Without CS-7017 in Chemotherapy-Naïve Subjects With Metastatic Non-Small Cell Lung Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 111 (actual)
• Sponsor: Daiichi Sankyo · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Metastatic Non-small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	CS7017 tablets	CS7017 tablets, strength 0.25 mg, two tablets, two times daily for twenty-five to thirty months
DRUG	Paclitaxel	Intravenous (IV), 200 mg/m\^2, once every three weeks for up to 18 weeks
DRUG	Carboplatin	IV, area under the curve (AUC) of 6, once every three weeks for up to 18 weeks
DRUG	Placebo Tablets	Placebo tablets matching CS-7017 tablets

Timeline

• Start date: 2008-12-01
• Primary completion: 2012-01-01
• Completion: 2012-08-01
• First posted: 2008-12-10
• Last updated: 2020-05-13
• Results posted: 2020-05-13

Locations

28 sites across 4 countries: United States, India, Poland, Romania