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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.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00716534
First Posted: July 16, 2008
Last Update Posted: April 29, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
  Purpose
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 (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 ( AbbVie (prior sponsor, Abbott) ):

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)

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00716534


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: AbbVie (prior sponsor, Abbott)
ClinicalTrials.gov Identifier: NCT00716534     History of Changes
Other Study ID Numbers: M10-301
2007-007107-32 ( EudraCT Number )
First Submitted: July 14, 2008
First Posted: July 16, 2008
Last Update Posted: April 29, 2013
Last Verified: April 2013

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