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


Tracking Information

Start Date  ICMJEJune 2008
Estimated Primary Completion DateMarch 2011   (final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE 
 (submitted: July 14, 2008)
Progression Free Survival (PFS) [ Time Frame: Disease Progression ] [ Designated as safety issue: No ]
Original Primary Outcome Measures  ICMJESame as current
Change HistoryComplete list of historical versions of study NCT00716534 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE 
 (submitted: June 10, 2009)
  • Overall survival, time to tumor progression, objective response rate, best response rate, best percent change in tumor size and duration of response [ Time Frame: Disease Progression ] [ Designated as safety issue: No ]
  • Survival Rate [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures  ICMJE 
 (submitted: July 14, 2008)
  • 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 ] [ Designated as safety issue: No ]
  • Survival Rate [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Descriptive Information

Brief Title  ICMJEStudy of Carboplatin/Paclitaxel in Combination With ABT-869 in Subjects With Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)
Official Title  ICMJEA 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
Brief 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.

Detailed Description 
Study PhasePhase II
Study Type  ICMJEInterventional
Study Design  ICMJETreatment, Randomized, Double Blind (Subject, Investigator), Single Group Assignment
Condition  ICMJEAdvanced or Metastatic Non-Small Cell Lung Cancer
Intervention  ICMJE
  • Drug: ABT-869
    See arm for details
    Other Name: ABT-869
  • Drug: Placebo
    see arm for details
Study Arms / Comparison Groups
  • A: Experimental
    12.5 mg ABT-869
    Intervention: Drug: ABT-869
  • B: Experimental
    7.5 mg ABT-869
    Intervention: Drug: ABT-869
  • C: Placebo Comparator
    Placebo (7.5 mg or 12.5 mg)
    Intervention: Drug: Placebo

Recruitment Information

Estimated Enrollment  ICMJE120
Completion Date 
Estimated Primary Completion DateMarch 2011   (final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
GenderBoth
Ages18 Years and older
Accepts Healthy VolunteersNo
Contacts  ICMJE
Contact: Brian L. Oliver, BS847-938-5570brian.oliver@abbott.com
Location Countries  ICMJEUnited States,   Australia,   Czech Republic,   Russian Federation,   Singapore

Administrative Information

NCT ID  ICMJENCT00716534
Responsible PartyJustin Ricker MD, PhD/Global Medical Director, Abbott
Study ID Numbers  ICMJEM10-301
Study Sponsor  ICMJEAbbott
Collaborators  ICMJEGenentech
Investigators  ICMJE 
Information Provided ByAbbott