Study of ABT-869 in Subjects With Advanced Non-small Cell Lung Cancer (NSCLC)

March 29, 2013 updated by: AbbVie (prior sponsor, Abbott)

An Open-Label, Randomized, Phase 2 Study of Efficacy and Tolerability of ABT-869 in Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)

The purpose of this study is to evaluate the effect of the ABT-869 on the NSCLC subjects.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

140

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Barrie, Canada, L4M 6M2
        • Site Reference ID/Investigator# 6040
      • Ottawa, Canada, K1H 8L6
        • Site Reference ID/Investigator# 5275
      • Toronto, Canada, M5G 2M9
        • Site Reference ID/Investigator# 6572
  • France
      • Marseille cedex 09, France, 13274
        • Site Reference ID/Investigator# 7756
      • Toulouse, France, 31059
        • Site Reference ID/Investigator# 8068
      • Villejuif, France, 94805
        • Site Reference ID/Investigator# 8069
  • Singapore
      • Singapore, Singapore, 119228
        • Site Reference ID/Investigator# 5660
      • Singapore, Singapore, 169610
        • Site Reference ID/Investigator# 5534
  • Taiwan
      • Taichung, Taiwan, 40705
        • Site Reference ID/Investigator# 5663
      • Taipei, Taiwan, 10002
        • Site Reference ID/Investigator# 5640
  • United States
    • California
      • Fountain Valley, California, United States, 92708
        • Site Reference ID/Investigator# 7194
      • Los Angeles, California, United States, 90033
        • Site Reference ID/Investigator# 5617
      • Sacramento, California, United States, 95817
        • Site Reference ID/Investigator# 7934
    • Colorado
      • Aurora, Colorado, United States, 80045-0510
        • Site Reference ID/Investigator# 5646
    • Connecticut
      • Waterbury, Connecticut, United States, 06708
        • Site Reference ID/Investigator# 6627
    • Delaware
      • Newark, Delaware, United States, 19718
        • Site Reference ID/Investigator# 7868
    • Florida
      • Port St. Lucie, Florida, United States, 34952
        • Site Reference ID/Investigator# 7616
    • Illinois
      • Chicago, Illinois, United States, 60637
        • Site Reference ID/Investigator# 5648
      • Evanston, Illinois, United States, 60201
        • Site Reference ID/Investigator# 6739
      • Harvey, Illinois, United States, 60426
        • Site Reference ID/Investigator# 8100
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Site Reference ID/Investigator# 5269
    • Missouri
      • St. Louis, Missouri, United States, 63110
        • Site Reference ID/Investigator# 6042
    • New Jersey
      • East Orange, New Jersey, United States, 07018
        • Site Reference ID/Investigator# 6680
      • Voorhees, New Jersey, United States, 08043
        • Site Reference ID/Investigator# 5603
    • New York
      • Buffalo, New York, United States, 14263
        • Site Reference ID/Investigator# 5652
    • North Carolina
      • Charlotte, North Carolina, United States, 28211
        • Site Reference ID/Investigator# 6184
      • Greensboro, North Carolina, United States, 27403
        • Site Reference ID/Investigator# 6777
    • Tennessee
      • Memphis, Tennessee, United States, 38120
        • Site Reference ID/Investigator# 5650

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subject must be histologically or cytologically diagnosed with advanced or metastatic NSCLC
  • Subjects must have at least one lesion measurable by CT scan as defined by RECIST
  • The measurable lesion may have not received radiation therapy
  • Subject has an Eastern Cooperative Oncology Group (ECOG) Performance status of 0-2
  • Subject has received at least one prior line of systemic treatment but no more than two treatment regimen(s) for advanced or metastatic NSCLC. In addition, the subject may have received systemic neo-adjuvant or adjuvant chemotherapy for NSCLC
  • Adequate organ function

Exclusion Criteria:

  • Subject has received targeted VEGF/PDGF TKI (tyrosine kinase inhibitor) therapy. Prior Avastin is allowed.
  • Subject has untreated brain or meningeal metastases.
  • History of greater than 10% weight loss
  • Subject has clinically relevant hemoptysis
  • The subject has proteinuria CTC Grade > 1
  • The subject currently exhibits symptomatic or persistent, uncontrolled hypertension defined as diastolic blood pressure > 100 mmHg or systolic blood pressure > 150 mmHg. Subjects may be re-screened if blood pressure is shown to be controlled with or without intervention.
  • The subject has a documented left ventricular ejection fraction < 50%

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ABT-869 0.25 mg/kg
Approximately half of the subjects were randomized to receive the high dose
Drug: ABT-869 .25 mg/kg
Subjects will take linifanib (ABT-869) based on body weight. Dosing will be determined at baseline and will be based on randomization to either 0.10 mg or 0.25 mg of ABT-869 per kilogram of body weight.
Experimental: ABT-869 0.10 mg/kg
Approximately half of the subjects were randomized to receive the Low Dose
Drug: ABT-869 0.10 mg/kg
Subjects will take linifanib (ABT-869) based on body weight. Dosing will be determined at baseline and will be based on randomization to either 0.10 mg or 0.25 mg of ABT-869 per kilogram of body weight.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Progression Free Rate (PFR)
Time Frame: Week 16
Week 16

Secondary Outcome Measures

Outcome Measure
Time Frame
Objective Response Rate
Time Frame: Week 16
Week 16

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AbbVie (prior sponsor, Abbott)

Collaborators

Genentech, Inc.

Investigators

  • Study Director: Justin Ricker, MD, AbbVie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2007

Primary Completion (Actual)

June 1, 2011

Study Completion (Actual)

June 1, 2012

Study Registration Dates

First Submitted

August 16, 2007

First Submitted That Met QC Criteria

August 16, 2007

First Posted (Estimate)

August 17, 2007

Study Record Updates

Last Update Posted (Estimate)

April 5, 2013

Last Update Submitted That Met QC Criteria

March 29, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M06-880
  • 2007-005245-37 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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