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A Phase 2 Randomized, Placebo-Controlled, Double-Blind Study of Carboplatin/Paclitaxel in Combination With ABT-869 Versus Carboplatin/Paclitaxel Alone in Subjects With Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) as First-Line Treatment


Phase 2
18 Years
N/A
Not Enrolling
Both
Advanced or Metastatic Non-Small Cell Lung Cancer

Thank you

Trial Information

A Phase 2 Randomized, Placebo-Controlled, Double-Blind Study of Carboplatin/Paclitaxel in Combination With ABT-869 Versus Carboplatin/Paclitaxel Alone in Subjects With Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) as First-Line Treatment


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

Progression Free Survival (PFS)

Outcome Time Frame:

Disease Progression

Safety Issue:

No

Principal Investigator

Justin L. Ricker, MD

Investigator Role:

Study Director

Investigator Affiliation:

AbbVie

Authority:

United States: Food and Drug Administration

Study ID:

M10-301

NCT ID:

NCT00716534

Start Date:

June 2008

Completion Date:

April 2012

Related Keywords:

  • Advanced or Metastatic Non-Small Cell Lung Cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

Site Reference ID/Investigator# 15850Chandler, Arizona  85224-5665
Site Reference ID/Investigator# 15846Peoria, Arizona  85381
Site Reference ID/Investigator# 15841Miami, Florida  33136
Site Reference ID/Investigator# 7179Atlanta, Georgia  30322
Site Reference ID/Investigator# 15851Lansing, Michigan  48912
Site Reference ID/Investigator# 15844Lebanon, New Hampshire  3756
Site Reference ID/Investigator# 22443Hackensack, New Jersey  07601
Site Reference ID/Investigator# 15848Greensboro, North Carolina  27403
Site Reference ID/Investigator# 22444Canton, Ohio  44718
Site Reference ID/Investigator# 15847Cleveland, Ohio  44195
Site Reference ID/Investigator# 26842Hershey, Pennsylvania  17033-0850
Site Reference ID/Investigator# 13101Philadelphia, Pennsylvania  19106
Site Reference ID/Investigator# 24122Philadelphia, Pennsylvania  19107