Clinical trial NCT00517790: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non-Small Cell Lung Cancer (NSCLC)
Keywords: Refractory
Metastatic
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
Collaborators: name: Genentech, Inc.
First posted: 2007-08-17
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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%

Primary outcomes:
measure: Progression Free Rate (PFR)
timeFrame: Week 16
Secondary outcomes:
measure: Objective Response Rate
timeFrame: Week 16
Other outcomes:
Locations:
city: Fountain Valley
country: United States
facility: Site Reference ID/Investigator# 7194
state: California
city: Los Angeles
country: United States
facility: Site Reference ID/Investigator# 5617
state: California
city: Sacramento
country: United States
facility: Site Reference ID/Investigator# 7934
state: California
city: Aurora
country: United States
facility: Site Reference ID/Investigator# 5646
state: Colorado
city: Waterbury
country: United States
facility: Site Reference ID/Investigator# 6627
state: Connecticut
city: Newark
country: United States
facility: Site Reference ID/Investigator# 7868
state: Delaware
city: Port St. Lucie
country: United States
facility: Site Reference ID/Investigator# 7616
state: Florida
city: Chicago
country: United States
facility: Site Reference ID/Investigator# 5648
state: Illinois
city: Evanston
country: United States
facility: Site Reference ID/Investigator# 6739
state: Illinois
city: Harvey
country: United States
facility: Site Reference ID/Investigator# 8100
state: Illinois
city: Indianapolis
country: United States
facility: Site Reference ID/Investigator# 5269
state: Indiana
city: St. Louis
country: United States
facility: Site Reference ID/Investigator# 6042
state: Missouri
city: East Orange
country: United States
facility: Site Reference ID/Investigator# 6680
state: New Jersey
city: Voorhees
country: United States
facility: Site Reference ID/Investigator# 5603
state: New Jersey
city: Buffalo
country: United States
facility: Site Reference ID/Investigator# 5652
state: New York
city: Charlotte
country: United States
facility: Site Reference ID/Investigator# 6184
state: North Carolina
city: Greensboro
country: United States
facility: Site Reference ID/Investigator# 6777
state: North Carolina
city: Memphis
country: United States
facility: Site Reference ID/Investigator# 5650
state: Tennessee
city: Barrie
country: Canada
facility: Site Reference ID/Investigator# 6040
city: Ottawa
country: Canada
facility: Site Reference ID/Investigator# 5275
city: Toronto
country: Canada
facility: Site Reference ID/Investigator# 6572
city: Marseille cedex 09
country: France
facility: Site Reference ID/Investigator# 7756
city: Toulouse
country: France
facility: Site Reference ID/Investigator# 8068
city: Villejuif
country: France
facility: Site Reference ID/Investigator# 8069
city: Singapore
country: Singapore
facility: Site Reference ID/Investigator# 5660
city: Singapore
country: Singapore
facility: Site Reference ID/Investigator# 5534
city: Taichung
country: Taiwan
facility: Site Reference ID/Investigator# 5663
city: Taipei
country: Taiwan
facility: Site Reference ID/Investigator# 5640
Study officials:
affiliation: AbbVie
name: Justin Ricker, MD
role: STUDY_DIRECTOR
References:
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.