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

This study has been completed.
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT00517790
First received: August 16, 2007
Last updated: March 29, 2013
Last verified: January 2013

August 16, 2007
March 29, 2013
August 2007
June 2011   (final data collection date for primary outcome measure)
Progression Free Rate (PFR) [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
Progression Free Rate (PFR) [ Time Frame: Week 16 ]
Complete list of historical versions of study NCT00517790 on ClinicalTrials.gov Archive Site
Objective Response Rate [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
Objective Response Rate (ORR) [ Time Frame: Week 16 ]
Not Provided
Not Provided
 
Study of ABT-869 in Subjects With Advanced Non-small Cell Lung Cancer (NSCLC)
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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Non-Small Cell Lung Cancer (NSCLC)
  • 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.
  • 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.
  • Experimental: ABT-869 0.25 mg/kg
    Approximately half of the subjects were randomized to receive the high dose
    Intervention: Drug: ABT-869 .25 mg/kg
  • Experimental: ABT-869 0.10 mg/kg
    Approximately half of the subjects were randomized to receive the Low Dose
    Intervention: Drug: ABT-869 0.10 mg/kg
Tan EH, Goss GD, Salgia R, Besse B, Gandara DR, Hanna NH, Yang JC, Thertulien R, Wertheim M, Mazieres J, Hensing T, Lee C, Gupta N, Pradhan R, Qian J, Qin Q, Scappaticci FA, Ricker JL, Carlson DM, Soo RA. Phase 2 trial of Linifanib (ABT-869) in patients with advanced non-small cell lung cancer. J Thorac Oncol. 2011 Aug;6(8):1418-25. doi: 10.1097/JTO.0b013e318220c93e.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
140
June 2012
June 2011   (final data collection date for primary outcome measure)

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%
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada,   Singapore,   Taiwan,   France
 
NCT00517790
M06-880, 2007-005245-37
No
AbbVie ( AbbVie (prior sponsor, Abbott) )
AbbVie (prior sponsor, Abbott)
Genentech, Inc.
Study Director: Justin Ricker, MD AbbVie
AbbVie
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP