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

Primary Purpose

Non-Small Cell Lung Cancer (NSCLC)

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
ABT-869 .25 mg/kg
ABT-869 0.10 mg/kg
Sponsored by
AbbVie (prior sponsor, Abbott)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-Small Cell Lung Cancer (NSCLC) focused on measuring Refractory, Metastatic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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%

Sites / Locations

  • Site Reference ID/Investigator# 7194
  • Site Reference ID/Investigator# 5617
  • Site Reference ID/Investigator# 7934
  • Site Reference ID/Investigator# 5646
  • Site Reference ID/Investigator# 6627
  • Site Reference ID/Investigator# 7868
  • Site Reference ID/Investigator# 7616
  • Site Reference ID/Investigator# 5648
  • Site Reference ID/Investigator# 6739
  • Site Reference ID/Investigator# 8100
  • Site Reference ID/Investigator# 5269
  • Site Reference ID/Investigator# 6042
  • Site Reference ID/Investigator# 6680
  • Site Reference ID/Investigator# 5603
  • Site Reference ID/Investigator# 5652
  • Site Reference ID/Investigator# 6184
  • Site Reference ID/Investigator# 6777
  • Site Reference ID/Investigator# 5650
  • Site Reference ID/Investigator# 6040
  • Site Reference ID/Investigator# 5275
  • Site Reference ID/Investigator# 6572
  • Site Reference ID/Investigator# 7756
  • Site Reference ID/Investigator# 8068
  • Site Reference ID/Investigator# 8069
  • Site Reference ID/Investigator# 5660
  • Site Reference ID/Investigator# 5534
  • Site Reference ID/Investigator# 5663
  • Site Reference ID/Investigator# 5640

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

ABT-869 0.25 mg/kg

ABT-869 0.10 mg/kg

Arm Description

Approximately half of the subjects were randomized to receive the high dose

Approximately half of the subjects were randomized to receive the Low Dose

Outcomes

Primary Outcome Measures

Progression Free Rate (PFR)

Secondary Outcome Measures

Objective Response Rate

Full Information

First Posted
August 16, 2007
Last Updated
March 29, 2013
Sponsor
AbbVie (prior sponsor, Abbott)
Collaborators
Genentech, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00517790
Brief Title
Study of ABT-869 in Subjects With Advanced Non-small Cell Lung Cancer (NSCLC)
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 Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
August 2007 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AbbVie (prior sponsor, Abbott)
Collaborators
Genentech, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Small Cell Lung Cancer (NSCLC)
Keywords
Refractory, Metastatic

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
140 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ABT-869 0.25 mg/kg
Arm Type
Experimental
Arm Description
Approximately half of the subjects were randomized to receive the high dose
Arm Title
ABT-869 0.10 mg/kg
Arm Type
Experimental
Arm Description
Approximately half of the subjects were randomized to receive the Low Dose
Intervention Type
Drug
Intervention Name(s)
ABT-869 .25 mg/kg
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
ABT-869 0.10 mg/kg
Intervention Description
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 Measure Information:
Title
Progression Free Rate (PFR)
Time Frame
Week 16
Secondary Outcome Measure Information:
Title
Objective Response Rate
Time Frame
Week 16

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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%
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Justin Ricker, MD
Organizational Affiliation
AbbVie
Official's Role
Study Director
Facility Information:
Facility Name
Site Reference ID/Investigator# 7194
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
Country
United States
Facility Name
Site Reference ID/Investigator# 5617
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Site Reference ID/Investigator# 7934
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
Site Reference ID/Investigator# 5646
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045-0510
Country
United States
Facility Name
Site Reference ID/Investigator# 6627
City
Waterbury
State/Province
Connecticut
ZIP/Postal Code
06708
Country
United States
Facility Name
Site Reference ID/Investigator# 7868
City
Newark
State/Province
Delaware
ZIP/Postal Code
19718
Country
United States
Facility Name
Site Reference ID/Investigator# 7616
City
Port St. Lucie
State/Province
Florida
ZIP/Postal Code
34952
Country
United States
Facility Name
Site Reference ID/Investigator# 5648
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Site Reference ID/Investigator# 6739
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60201
Country
United States
Facility Name
Site Reference ID/Investigator# 8100
City
Harvey
State/Province
Illinois
ZIP/Postal Code
60426
Country
United States
Facility Name
Site Reference ID/Investigator# 5269
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Site Reference ID/Investigator# 6042
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Site Reference ID/Investigator# 6680
City
East Orange
State/Province
New Jersey
ZIP/Postal Code
07018
Country
United States
Facility Name
Site Reference ID/Investigator# 5603
City
Voorhees
State/Province
New Jersey
ZIP/Postal Code
08043
Country
United States
Facility Name
Site Reference ID/Investigator# 5652
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263
Country
United States
Facility Name
Site Reference ID/Investigator# 6184
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28211
Country
United States
Facility Name
Site Reference ID/Investigator# 6777
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27403
Country
United States
Facility Name
Site Reference ID/Investigator# 5650
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38120
Country
United States
Facility Name
Site Reference ID/Investigator# 6040
City
Barrie
ZIP/Postal Code
L4M 6M2
Country
Canada
Facility Name
Site Reference ID/Investigator# 5275
City
Ottawa
ZIP/Postal Code
K1H 8L6
Country
Canada
Facility Name
Site Reference ID/Investigator# 6572
City
Toronto
ZIP/Postal Code
M5G 2M9
Country
Canada
Facility Name
Site Reference ID/Investigator# 7756
City
Marseille cedex 09
ZIP/Postal Code
13274
Country
France
Facility Name
Site Reference ID/Investigator# 8068
City
Toulouse
ZIP/Postal Code
31059
Country
France
Facility Name
Site Reference ID/Investigator# 8069
City
Villejuif
ZIP/Postal Code
94805
Country
France
Facility Name
Site Reference ID/Investigator# 5660
City
Singapore
ZIP/Postal Code
119228
Country
Singapore
Facility Name
Site Reference ID/Investigator# 5534
City
Singapore
ZIP/Postal Code
169610
Country
Singapore
Facility Name
Site Reference ID/Investigator# 5663
City
Taichung
ZIP/Postal Code
40705
Country
Taiwan
Facility Name
Site Reference ID/Investigator# 5640
City
Taipei
ZIP/Postal Code
10002
Country
Taiwan

12. IPD Sharing Statement

Citations:
PubMed Identifier
21597387
Citation
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.
Results Reference
derived

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

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