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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00517790
Recruitment Status : Completed
First Posted : August 17, 2007
Last Update Posted : April 5, 2013
Genentech, Inc.
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )

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

Condition or disease Intervention/treatment Phase
Non-Small Cell Lung Cancer (NSCLC) Drug: ABT-869 .25 mg/kg Drug: ABT-869 0.10 mg/kg Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label, Randomized, Phase 2 Study of Efficacy and Tolerability of ABT-869 in Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)
Study Start Date : August 2007
Actual Primary Completion Date : June 2011
Actual Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

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.

Primary Outcome Measures :
  1. Progression Free Rate (PFR) [ Time Frame: Week 16 ]

Secondary Outcome Measures :
  1. Objective Response Rate [ Time Frame: Week 16 ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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%

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00517790

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

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: AbbVie (prior sponsor, Abbott) Identifier: NCT00517790     History of Changes
Other Study ID Numbers: M06-880
2007-005245-37 ( EudraCT Number )
First Posted: August 17, 2007    Key Record Dates
Last Update Posted: April 5, 2013
Last Verified: January 2013

Keywords provided by AbbVie ( AbbVie (prior sponsor, Abbott) ):

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms