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

NCT00517790 | Completed Phase 2

• 2 other identifiers: M06-8802007-005245-37
• Study Type: interventional
• Target: 140
• Locations: 5 countries
• Sites: 28

Brief Summary

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

Conditions

Non-Small Cell Lung Cancer (NSCLC)

Keywords

Refractory; Metastatic

Outcome Measures

Primary Outcomes (1)

• Progression Free Rate (PFR)

  Week 16

Secondary Outcomes (1)

• Objective Response Rate

  Week 16

Study Arms (2)

ABT-869 0.25 mg/kg

EXPERIMENTAL

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

Drug: ABT-869 .25 mg/kg

ABT-869 0.10 mg/kg

EXPERIMENTAL

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

Drug: ABT-869 0.10 mg/kg

Interventions

ABT-869 .25 mg/kg DRUG

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 0.25 mg/kg

ABT-869 0.10 mg/kg DRUG

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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%

Sponsors & Collaborators

• AbbVie (prior sponsor, Abbott): lead
• Genentech, Inc.: collaborator

Study Sites (28)

Site Reference ID/Investigator# 7194

Fountain Valley, California, 92708, United States

Location

Site Reference ID/Investigator# 5617

Los Angeles, California, 90033, United States

Location

Site Reference ID/Investigator# 7934

Sacramento, California, 95817, United States

Location

Site Reference ID/Investigator# 5646

Aurora, Colorado, 80045-0510, United States

Location

Site Reference ID/Investigator# 6627

Waterbury, Connecticut, 06708, United States

Location

Site Reference ID/Investigator# 7868

Newark, Delaware, 19718, United States

Location

Site Reference ID/Investigator# 7616

Port Saint Lucie, Florida, 34952, United States

Location

Site Reference ID/Investigator# 5648

Chicago, Illinois, 60637, United States

Location

Site Reference ID/Investigator# 6739

Evanston, Illinois, 60201, United States

Location

Site Reference ID/Investigator# 8100

Harvey, Illinois, 60426, United States

Location

Site Reference ID/Investigator# 5269

Indianapolis, Indiana, 46202, United States

Location

Site Reference ID/Investigator# 6042

St Louis, Missouri, 63110, United States

Location

Site Reference ID/Investigator# 6680

East Orange, New Jersey, 07018, United States

Location

Site Reference ID/Investigator# 5603

Voorhees Township, New Jersey, 08043, United States

Location

Site Reference ID/Investigator# 5652

Buffalo, New York, 14263, United States

Location

Site Reference ID/Investigator# 6184

Charlotte, North Carolina, 28211, United States

Location

Site Reference ID/Investigator# 6777

Greensboro, North Carolina, 27403, United States

Location

Site Reference ID/Investigator# 5650

Memphis, Tennessee, 38120, United States

Location

Site Reference ID/Investigator# 6040

Barrie, L4M 6M2, Canada

Location

Site Reference ID/Investigator# 5275

Ottawa, K1H 8L6, Canada

Location

Site Reference ID/Investigator# 6572

Toronto, M5G 2M9, Canada

Location

Site Reference ID/Investigator# 7756

Marseille, 13274, France

Location

Site Reference ID/Investigator# 8068

Toulouse, 31059, France

Location

Site Reference ID/Investigator# 8069

Villejuif, 94805, France

Location

Site Reference ID/Investigator# 5660

Singapore, 119228, Singapore

Location

Site Reference ID/Investigator# 5534

Singapore, 169610, Singapore

Location

Site Reference ID/Investigator# 5663

Taichung, 40705, Taiwan

Location

Site Reference ID/Investigator# 5640

Taipei, 10002, Taiwan

Location

Related Publications (1)

• 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.

  PMID: 21597387 DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Neoplasm Metastasis

Interventions

linifanib

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Justin Ricker, MD

  AbbVie

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2007
• First Posted: August 17, 2007
• Study Start: August 1, 2007
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2012
• Last Updated: April 5, 2013

Record last verified: 2013-01

Locations

US (18); CA (3); SG (2); TW (2); FR (3)