A Study of Linifanib (ABT-869) in Combination With Carboplatin/Paclitaxel in Japanese Subjects With Non-Small Cell Lung Cancer (NSCLC)

Phase 1

Completed

• Conditions: Non-Small Cell Lung Cancer
• Interventions: Drug: Linifanib; Drug: Carboplatin; Drug: Paclitaxel

• Registration Number: NCT01225302
• Lead Sponsor: AbbVie

Brief Summary

The primary objective of this study is to assess the safety and pharmacokinetics of linifanib, and identify tolerable dose of linifanib (ABT-869) in combination with carboplatin and paclitaxel in Japanese subjects with advanced or metastatic non-small cell lung cancer (NSCLC). Secondary objective is to obtain a preliminary efficacy of anti-tumor activity in the subjects as first-line treatment.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-09
• Study First Submitted: 2010-09-28
• Study First Submitted QC: 2010-10-19
• Study First Posted: 2010-10-21
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Status Verified: 2012-07
• Last Update Submitted: 2017-11-17
• Last Update Posted: 2017-11-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm B	Linifanib	-
Arm A	Linifanib	-
Arm A	Carboplatin	-
Arm A	Paclitaxel	-
Arm B	Carboplatin	-
Arm B	Paclitaxel	-

Primary Outcome Measures

Name	Time	Method
Safety (Number of patients with adverse events and/or dose-limiting toxicities)	At each treatment visit (weekly for 6 weeks, then every 3 weeks)	Evaluation of vital signs, physical exams, clinical lab testing and adverse event monitoring.

Secondary Outcome Measures

Name	Time	Method
Preliminary tumor response	Week 54	Computed Tomography (CT) scan