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

This study has been completed.
Sponsor:
Collaborator:
Genentech
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
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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:

MedlinePlus related topics: Cancer Lung Cancer
U.S. FDA Resources

Further study details as provided by AbbVie:

Primary Outcome Measures:
  • Progression Free Rate (PFR) [ Time Frame: Week 16 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Objective Response Rate [ Time Frame: Week 16 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00517790

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

No publications provided by AbbVie

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT00517790     History of Changes
Other Study ID Numbers: M06-880, 2007-005245-37
Study First Received: August 16, 2007
Last Updated: March 29, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by AbbVie:
Refractory
Metastatic

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

ClinicalTrials.gov processed this record on May 19, 2013