NCT00832819

E7080 in Combination With Carboplatin and Paclitaxel in Patients With Non-small Cell Lung Cancer (NSCLC)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Eisai Co., Ltd. · Industry
• Sex: All
• Age: 20 Years – 74 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determined the maximum tolerated dose (MTD), safety and tolerability, pharmacokinetics, pharmacodynamics, and anti-tumor effect of E7080 administered continually twice daily in combination with carboplatin and paclitaxel to patients with advanced or metastatic non-small cell lung cancer.

Conditions

• Non-small-cell Lung Cancer

Interventions

Type	Name	Description
DRUG	E7080	Drug: E7080 will be administered orally starting at a dose of 6 mg twice daily during the 7-day run-in period and for 3 weeks (Cycle 1).
DRUG	E7080	Maximum tolerated dose determined in the Dose-Escalation Cohort will be administered to the Expansion Cohort. After E7080 is taken on Day 1, paclitaxel (200 mg/m2) will be administered intravenously (IV), followed by IV carboplatin (AUC 6.0 min/mg/mL).
DRUG	Paclitaxel	Paclitaxel (200 mg/m2) will be administered intravenously (IV) on Day 1 after administration of E7080.
DRUG	Carboplatin	Carboplatin (AUC 6.0 min/mg/mL) will be administered IV on Day 1 after administration of E7080 and Paclitaxel.

Timeline

• Start date: 2009-02-01
• Primary completion: 2011-07-01
• Completion: 2011-10-01
• First posted: 2009-01-30
• Last updated: 2015-04-30
• Results posted: 2015-03-06

Locations

3 sites across 1 country: Japan