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An Open-Label, Randomized, Phase 2 Study of Efficacy and Tolerability of ABT-869 in Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)

Phase 2
18 Years
Not Enrolling
Non-Small Cell Lung Cancer (NSCLC)

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Trial Information

An Open-Label, Randomized, Phase 2 Study of Efficacy and Tolerability of ABT-869 in Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)

Inclusion Criteria:

- Subject must be histologically or cytologically diagnosed with advanced or metastatic

- 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%

Type of Study:


Study Design:

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

Outcome Measure:

Progression Free Rate (PFR)

Outcome Time Frame:

Week 16

Safety Issue:


Principal Investigator

Justin Ricker, MD

Investigator Role:

Study Director

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




Start Date:

August 2007

Completion Date:

June 2012

Related Keywords:

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



Site Reference ID/Investigator# 7194Fountain Valley, California  92708
Site Reference ID/Investigator# 5617Los Angeles, California  90033
Site Reference ID/Investigator# 7934Sacramento, California  95817
Site Reference ID/Investigator# 5646Aurora, Colorado  80045-0510
Site Reference ID/Investigator# 6627Waterbury, Connecticut  06708
Site Reference ID/Investigator# 7868Newark, Delaware  19718
Site Reference ID/Investigator# 7616Port St. Lucie, Florida  34952
Site Reference ID/Investigator# 5648Chicago, Illinois  60637
Site Reference ID/Investigator# 6739Evanston, Illinois  60201
Site Reference ID/Investigator# 8100Harvey, Illinois  60426
Site Reference ID/Investigator# 5269Indianapolis, Indiana  46202
Site Reference ID/Investigator# 6042St. Louis, Missouri  63110
Site Reference ID/Investigator# 6680East Orange, New Jersey  07018
Site Reference ID/Investigator# 5603Voorhees, New Jersey  08043
Site Reference ID/Investigator# 5652Buffalo, New York  14263
Site Reference ID/Investigator# 6184Charlotte, North Carolina  28211
Site Reference ID/Investigator# 6777Greensboro, North Carolina  27403
Site Reference ID/Investigator# 5650Memphis, Tennessee  38120