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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) )
July 14, 2008
July 16, 2008
April 29, 2013
June 2008
April 2012   (Final data collection date for primary outcome measure)
Progression Free Survival (PFS) [ Time Frame: Disease Progression ]
Same as current
Complete list of historical versions of study NCT00716534 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Overall survival, time to tumor progression, objective response rate, best response rate, maximum percent reduction in tumor size and duration of response. [ Time Frame: Disease Progression ]
  • Survival Rate [ Time Frame: 12 Months ]
Not Provided
Not Provided
 
Study of Carboplatin/Paclitaxel in Combination With ABT-869 in Subjects With Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)
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
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Advanced or Metastatic Non-Small Cell Lung Cancer
  • Drug: ABT-869
    12.5 mg ABT-869
  • Drug: Placebo for ABT-869
    Placebo Comparator (12.5 mg or 7.5 mg)
    Other Name: Placebo
  • Drug: ABT-869
    7.5 mg ABT-869
  • Drug: Carboplatin
    Carboplatin (AUC 6 mg/mL/min)
  • Drug: Paclitaxel
    Paclitaxel (200 mg/m2)
  • Experimental: A
    12.5 mg ABT-869 + Carboplatin/Paclitaxel
    Interventions:
    • Drug: ABT-869
    • Drug: Carboplatin
    • Drug: Paclitaxel
  • Experimental: B
    7.5 mg ABT-869 + Carboplatin/Paclitaxel
    Interventions:
    • Drug: ABT-869
    • Drug: Carboplatin
    • Drug: Paclitaxel
  • Placebo Comparator: C
    Placebo (7.5 mg or 12.5 mg) + Carboplatin/Paclitaxel
    Interventions:
    • Drug: Placebo for ABT-869
    • Drug: Carboplatin
    • Drug: Paclitaxel
Ramalingam SS, Shtivelband M, Soo RA, Barrios CH, Makhson A, Segalla JG, Pittman KB, Kolman P, Pereira JR, Srkalovic G, Belani CP, Axelrod R, Owonikoko TK, Qin Q, Qian J, McKeegan EM, Devanarayan V, McKee MD, Ricker JL, Carlson DM, Gorbunova VA. Randomized phase II study of carboplatin and paclitaxel with either linifanib or placebo for advanced nonsquamous non-small-cell lung cancer. J Clin Oncol. 2015 Feb 10;33(5):433-41. doi: 10.1200/JCO.2014.55.7173. Epub 2015 Jan 5.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
145
April 2012
April 2012   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Brazil,   Czech Republic,   Russian Federation,   Singapore,   United States
New Zealand
 
NCT00716534
M10-301
2007-007107-32 ( EudraCT Number )
Not Provided
Not Provided
Not Provided
AbbVie ( AbbVie (prior sponsor, Abbott) )
AbbVie (prior sponsor, Abbott)
Genentech, Inc.
Study Director: Justin L. Ricker, MD AbbVie
AbbVie
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP