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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00517790
First Posted: August 17, 2007
Last Update Posted: April 5, 2013
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.
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
  Purpose
The purpose of this study is to evaluate the effect of the ABT-869 on the NSCLC subjects.

Condition Intervention 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
Study Design: 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)

Resource links provided by NLM:


Further study details as provided by AbbVie ( AbbVie (prior sponsor, Abbott) ):

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

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

Enrollment: 140
Study Start Date: August 2007
Study Completion Date: June 2012
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Information from the National Library of Medicine

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

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%
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00517790


  Show 28 Study Locations
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Genentech, Inc.
Investigators
Study Director: Justin Ricker, MD AbbVie
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: AbbVie (prior sponsor, Abbott)
ClinicalTrials.gov Identifier: NCT00517790     History of Changes
Other Study ID Numbers: M06-880
2007-005245-37 ( EudraCT Number )
First Submitted: August 16, 2007
First Posted: August 17, 2007
Last Update Posted: April 5, 2013
Last Verified: January 2013

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

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