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

This study has been completed.
Genentech, Inc.
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) ) Identifier:
First received: July 14, 2008
Last updated: April 19, 2013
Last verified: April 2013
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.

Condition Intervention Phase
Advanced or Metastatic Non-Small Cell Lung Cancer
Drug: ABT-869
Drug: Placebo for ABT-869
Drug: Carboplatin
Drug: Paclitaxel
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

Further study details as provided by AbbVie:

Primary Outcome Measures:
  • Progression Free Survival (PFS) [ Time Frame: Disease Progression ]

Secondary Outcome Measures:
  • Overall survival, best response rate, time to tumor progression, objective response rate, best percent change in tumor size, duration of response [ Time Frame: Disease Progression ]
  • Survival Rate [ Time Frame: 12 Months ]

Enrollment: 145
Study Start Date: June 2008
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
12.5 mg ABT-869 + Carboplatin/Paclitaxel
Drug: ABT-869
12.5 mg ABT-869
Drug: Carboplatin
Carboplatin (AUC 6 mg/mL/min)
Drug: Paclitaxel
Paclitaxel (200 mg/m2)
Experimental: B
7.5 mg ABT-869 + Carboplatin/Paclitaxel
Drug: ABT-869
7.5 mg ABT-869
Drug: Carboplatin
Carboplatin (AUC 6 mg/mL/min)
Drug: Paclitaxel
Paclitaxel (200 mg/m2)
Placebo Comparator: C
Placebo (7.5 mg or 12.5 mg) + Carboplatin/Paclitaxel
Drug: Placebo for ABT-869
Placebo Comparator (12.5 mg or 7.5 mg)
Other Name: Placebo
Drug: Carboplatin
Carboplatin (AUC 6 mg/mL/min)
Drug: Paclitaxel
Paclitaxel (200 mg/m2)


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
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Please refer to this study by its identifier: NCT00716534

  Show 37 Study Locations
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Genentech, Inc.
Study Director: Justin L. Ricker, MD AbbVie
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: AbbVie (prior sponsor, Abbott) Identifier: NCT00716534     History of Changes
Other Study ID Numbers: M10-301
2007-007107-32 ( EudraCT Number )
Study First Received: July 14, 2008
Last Updated: April 19, 2013

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action processed this record on April 27, 2017