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

Phase 1

Completed

• Conditions: Non-small-cell Lung Cancer
• Interventions: Drug: E7080; Drug: Paclitaxel; Drug: Carboplatin

• Registration Number: NCT00832819
• Lead Sponsor: Eisai Co., Ltd.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-01-23
• Study First Submitted QC: 2009-01-28
• Study First Posted: 2009-01-30
• Study Start: 2009-02
• Primary Completion: 2011-07
• Study Completion: 2011-10
• Status Verified: 2015-02
• Results First Submitted: 2015-02-21
• Results First Submitted QC: 2015-02-21
• Results First Posted: 2015-03-06
• Last Update Submitted: 2015-04-09
• Last Update Posted: 2015-04-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
E7080 (Dose Escalation Cohort)	Paclitaxel	This will be a dose-escalation evaluation of 12-18 participants to determine the maximum tolerated dose of E7080 in combination with paclitaxel and carboplatin.
E7080 (Dose Escalation Cohort)	Carboplatin	This will be a dose-escalation evaluation of 12-18 participants to determine the maximum tolerated dose of E7080 in combination with paclitaxel and carboplatin.
E7080 (Dose Escalation Cohort)	E7080	This will be a dose-escalation evaluation of 12-18 participants to determine the maximum tolerated dose of E7080 in combination with paclitaxel and carboplatin.
E7080 (Expansion Cohort)	E7080	Dosage of E7080 for Expansion Cohort will be determined based on the maximum tolerated dose in the Dose-Escalation Cohort.
E7080 (Expansion Cohort)	Carboplatin	Dosage of E7080 for Expansion Cohort will be determined based on the maximum tolerated dose in the Dose-Escalation Cohort.
E7080 (Expansion Cohort)	Paclitaxel	Dosage of E7080 for Expansion Cohort will be determined based on the maximum tolerated dose in the Dose-Escalation Cohort.

Primary Outcome Measures

Name	Time	Method
Maximum Tolerated Dose (MTD)	7 days during the run-in period (Cycle 0) and 3 weeks (21 days) from Cycle 1	Tolerability was confirmed by the frequency of occurrence of Dose Limiting Toxicities (DLTs) observed by the end of Cycle 1 in 6 participants.

Secondary Outcome Measures

Name	Time	Method
Anti-tumor Effect of E7080 in Combination With Carboplatin and Paclitaxel.	At Screening, on Day 22 of every even cycle, and at discontinuation
Pharmacokinetics and Pharmacodynamics of E7080 in Combination With Carboplatin and Paclitaxel.	At various time points until Day 22 of Cycle 1
To Evaluate the Safety and Tolerability of E7080 in Combination With Carboplatin and Paclitaxel.	Throughout the study until 30 days after last dose	Refer safety section for safety analysis