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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00517790

  Hide Study Locations
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
Canada
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
France
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
Singapore
Site Reference ID/Investigator# 5534
Singapore, Singapore, 169610
Site Reference ID/Investigator# 5660
Singapore, Singapore, 119228
Taiwan
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.
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:
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

ClinicalTrials.gov processed this record on October 19, 2014