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

Non-Small Cell Lung Cancer (NSCLC) Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00517790
• Other study ID #: M06-880
• Secondary ID: 2007-005245-37
• Status: Completed
• Phase: Phase 2
• First received: August 16, 2007
• Last updated: March 29, 2013
• Start date: August 2007
• Est. completion date: June 2012

Study information

• Verified date: January 2013
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: June 2012
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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%

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-Small Cell Lung Cancer (NSCLC)

Intervention

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.
• 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.

Locations

Country	Name	City	State
Canada	Site Reference ID/Investigator# 6040	Barrie
Canada	Site Reference ID/Investigator# 5275	Ottawa
Canada	Site Reference ID/Investigator# 6572	Toronto
France	Site Reference ID/Investigator# 7756	Marseille cedex 09
France	Site Reference ID/Investigator# 8068	Toulouse
France	Site Reference ID/Investigator# 8069	Villejuif
Singapore	Site Reference ID/Investigator# 5534	Singapore
Singapore	Site Reference ID/Investigator# 5660	Singapore
Taiwan	Site Reference ID/Investigator# 5663	Taichung
Taiwan	Site Reference ID/Investigator# 5640	Taipei
United States	Site Reference ID/Investigator# 5646	Aurora	Colorado
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# 5648	Chicago	Illinois
United States	Site Reference ID/Investigator# 6680	East Orange	New Jersey
United States	Site Reference ID/Investigator# 6739	Evanston	Illinois
United States	Site Reference ID/Investigator# 7194	Fountain Valley	California
United States	Site Reference ID/Investigator# 6777	Greensboro	North Carolina
United States	Site Reference ID/Investigator# 8100	Harvey	Illinois
United States	Site Reference ID/Investigator# 5269	Indianapolis	Indiana
United States	Site Reference ID/Investigator# 5617	Los Angeles	California
United States	Site Reference ID/Investigator# 5650	Memphis	Tennessee
United States	Site Reference ID/Investigator# 7868	Newark	Delaware
United States	Site Reference ID/Investigator# 7616	Port St. Lucie	Florida
United States	Site Reference ID/Investigator# 7934	Sacramento	California
United States	Site Reference ID/Investigator# 6042	St. Louis	Missouri
United States	Site Reference ID/Investigator# 5603	Voorhees	New Jersey
United States	Site Reference ID/Investigator# 6627	Waterbury	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
AbbVie (prior sponsor, Abbott)	Genentech, Inc.

Countries where clinical trial is conducted

United States,  Canada,  France,  Singapore,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression Free Rate (PFR)		Week 16	No
Secondary	Objective Response Rate		Week 16	No