Study of Carboplatin/Paclitaxel in Combination With ABT-869 in Subjects With Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)

• Status: Completed
• Trial end date: 2012-04-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is designed to determine the clinical efficacy and toxicity of ABT-869 in combination with carboplatin and paclitaxel in the treatment of subjects with advanced or metastatic NSCLC.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AbbVie (prior sponsor, Abbott)
• Collaborator: Genentech, Inc.
• Treatments: Albumin-Bound Paclitaxel; Carboplatin; Paclitaxel

Criteria

Inclusion Criteria:

• Subject must be at least 18 years of age.

• Subject must have cytologically or histologically confirmed non-squamous NSCLC

• Subject must have recurrent or advanced (Stage IIIb with pleural or pericardial effusion) or metastatic (Stage IV) disease that is not amenable to surgical resection or radiation with curative intent.

• Subject has measurable disease, defined as at least 1 unidimensional measurable lesion on a computed tomography (CT) scan as defined by RECIST (for subjects in the randomized portion only).

• Subject has an ECOG Performance Score of 0-1.

• Willing to take adequate measures to prevent pregnancy.

Exclusion Criteria:

• The subject has NSCLC with a predominant squamous cell histology

• Subject has hypersensitivity to paclitaxel.

• Subject has received any anti-cancer therapy for treatment of NSCLC.

• Subject has received radiation therapy within 21 days of Study Day 1.

• Subject has had major surgery within 21 days.

• Subject has untreated brain or meningeal metastases.

• Subject is receiving therapeutic anticoagulation therapy.

• Subject has a central thoracic tumor lesion as defined by location within the hilar structures.

• Subject has proteinuria CTC Grade > 1 at baseline.

• Subject has a history of, or currently exhibits clinically significant cancer related events of bleeding.

• The subject currently exhibits symptomatic or persistent, uncontrolled hypertension defined as diastolic blood pressure (BP) > 90 mm Hg or systolic BP > 140 mm Hg.

• The subject has a history of myocardial infarction, stroke or Transient Ischemic Attack (TIA) within 6 months of Study Day 1.

• The subject has a documented left ventricular (LV) ejection fraction < 50%.

• The subject has known autoimmune disease with renal involvement (i.e., lupus).

• The subject is receiving combination anti-retroviral therapy for HIV.

• The subject has clinically significant uncontrolled condition(s).

• The subject has a history of another active cancer within the past 5 years.

• The subject has active ulcerative colitis, Crohn's disease, celiac disease or any other conditions that interfere with absorption.

• The subject has a medical condition, which in the opinion of the study investigator places them at an unacceptably high risk for toxicities.

• The subject is pregnant or breast feeding.