Study of ABT-869 in Subjects With Advanced Non-small Cell Lung Cancer (NSCLC)
NCT ID: NCT00517790
Last Updated: 2013-04-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
140 participants
INTERVENTIONAL
2007-08-31
2012-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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ABT-869 0.25 mg/kg
Approximately half of the subjects were randomized to receive the high dose
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.
ABT-869 0.10 mg/kg
Approximately half of the subjects were randomized to receive the Low Dose
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.
Interventions
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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.
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 Criteria
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Inclusion Criteria
* 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 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%
18 Years
ALL
No
Sponsors
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Genentech, Inc.
INDUSTRY
AbbVie (prior sponsor, Abbott)
INDUSTRY
Responsible Party
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Principal Investigators
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Justin Ricker, MD
Role: STUDY_DIRECTOR
AbbVie
Locations
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Site Reference ID/Investigator# 7194
Fountain Valley, California, United States
Site Reference ID/Investigator# 5617
Los Angeles, California, United States
Site Reference ID/Investigator# 7934
Sacramento, California, United States
Site Reference ID/Investigator# 5646
Aurora, Colorado, United States
Site Reference ID/Investigator# 6627
Waterbury, Connecticut, United States
Site Reference ID/Investigator# 7868
Newark, Delaware, United States
Site Reference ID/Investigator# 7616
Port Saint Lucie, Florida, United States
Site Reference ID/Investigator# 5648
Chicago, Illinois, United States
Site Reference ID/Investigator# 6739
Evanston, Illinois, United States
Site Reference ID/Investigator# 8100
Harvey, Illinois, United States
Site Reference ID/Investigator# 5269
Indianapolis, Indiana, United States
Site Reference ID/Investigator# 6042
St Louis, Missouri, United States
Site Reference ID/Investigator# 6680
East Orange, New Jersey, United States
Site Reference ID/Investigator# 5603
Voorhees Township, New Jersey, United States
Site Reference ID/Investigator# 5652
Buffalo, New York, United States
Site Reference ID/Investigator# 6184
Charlotte, North Carolina, United States
Site Reference ID/Investigator# 6777
Greensboro, North Carolina, United States
Site Reference ID/Investigator# 5650
Memphis, Tennessee, United States
Site Reference ID/Investigator# 6040
Barrie, , Canada
Site Reference ID/Investigator# 5275
Ottawa, , Canada
Site Reference ID/Investigator# 6572
Toronto, , Canada
Site Reference ID/Investigator# 7756
Marseille, , France
Site Reference ID/Investigator# 8068
Toulouse, , France
Site Reference ID/Investigator# 8069
Villejuif, , France
Site Reference ID/Investigator# 5660
Singapore, , Singapore
Site Reference ID/Investigator# 5534
Singapore, , Singapore
Site Reference ID/Investigator# 5663
Taichung, , Taiwan
Site Reference ID/Investigator# 5640
Taipei, , Taiwan
Countries
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References
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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.
Other Identifiers
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2007-005245-37
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
M06-880
Identifier Type: -
Identifier Source: org_study_id
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