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

April 19, 2013 updated by: AbbVie (prior sponsor, Abbott)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

145

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Bedford Park, Australia, 5042
        • Site Reference ID/Investigator# 19042
      • Cairns, Australia, 4870
        • Site Reference ID/Investigator# 23682
      • Lismore, Australia, 2480
        • Site Reference ID/Investigator# 21862
      • Woodville South, Australia, 5011
        • Site Reference ID/Investigator# 19043
  • Brazil
      • Jau, Brazil, 17210-120
        • Site Reference ID/Investigator# 17703
      • Porto Alegre, Brazil, 90050-170
        • Site Reference ID/Investigator# 23522
      • Porto Alegre, Brazil, 90610-000
        • Site Reference ID/Investigator# 15601
      • Rio de Janeiro, Brazil, 20231-050
        • Site Reference ID/Investigator# 17704
      • Santo Andre, Brazil, 09060-650
        • Site Reference ID/Investigator# 22684
      • Sao Paulo, Brazil, 01224-010
        • Site Reference ID/Investigator# 17702
      • Sao Paulo, Brazil, 04024-002
        • Site Reference ID/Investigator# 23582
  • Czech Republic
      • Kyjov, Czech Republic, 69733
        • Site Reference ID/Investigator# 18964
      • Nachod, Czech Republic, 54769
        • Site Reference ID/Investigator# 22504
      • Olomouc, Czech Republic, 77520
        • Site Reference ID/Investigator# 18963
      • Prague 2, Czech Republic, 12808
        • Site Reference ID/Investigator# 18962
      • Pribram V, Czech Republic, 26995
        • Site Reference ID/Investigator# 19022
  • Russian Federation
      • Kazan, Russian Federation, 420029
        • Site Reference ID/Investigator# 38003
      • Kirov, Russian Federation, 610021
        • Site Reference ID/Investigator# 38260
      • Moscow, Russian Federation, 115478
        • Site Reference ID/Investigator# 18064
      • Moscow, Russian Federation, 115478
        • Site Reference ID/Investigator# 18065
      • Moscow, Russian Federation, 115478
        • Site Reference ID/Investigator# 23312
      • Moscow, Russian Federation, 143423
        • Site Reference ID/Investigator# 18066
      • St. Petersburg, Russian Federation, 198255
        • Site Reference ID/Investigator# 23562
  • Singapore
      • Singapore, Singapore, 119228
        • Site Reference ID/Investigator# 18961
  • United States
    • Arizona
      • Chandler, Arizona, United States, 85224
        • Site Reference ID/Investigator# 15850
      • Peoria, Arizona, United States, 85381
        • Site Reference ID/Investigator# 15846
    • Florida
      • Miami, Florida, United States, 33136
        • Site Reference ID/Investigator# 15841
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Site Reference ID/Investigator# 7179
    • Michigan
      • Lansing, Michigan, United States, 48912
        • Site Reference ID/Investigator# 15851
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Site Reference ID/Investigator# 15844
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Site Reference ID/Investigator# 22443
    • North Carolina
      • Greensboro, North Carolina, United States, 27403
        • Site Reference ID/Investigator# 15848
    • Ohio
      • Canton, Ohio, United States, 44718
        • Site Reference ID/Investigator# 22444
      • Cleveland, Ohio, United States, 44195
        • Site Reference ID/Investigator# 15847
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033-0850
        • Site Reference ID/Investigator# 26842
      • Philadelphia, Pennsylvania, United States, 19106
        • Site Reference ID/Investigator# 13101
      • Philadelphia, Pennsylvania, United States, 19107
        • Site Reference ID/Investigator# 24122

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: A
12.5 mg ABT-869 + Carboplatin/Paclitaxel
Drug: ABT-869
12.5 mg ABT-869
Drug: ABT-869
7.5 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
12.5 mg ABT-869
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: Carboplatin
Carboplatin (AUC 6 mg/mL/min)
Drug: Paclitaxel
Paclitaxel (200 mg/m2)
Drug: Placebo for ABT-869
Placebo Comparator (12.5 mg or 7.5 mg)
Other Names:
  • Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Progression Free Survival (PFS)
Time Frame: Disease Progression
Disease Progression

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Disease Progression
Survival Rate
Time Frame: 12 Months
12 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AbbVie (prior sponsor, Abbott)

Collaborators

Genentech, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2008

Primary Completion (ACTUAL)

April 1, 2012

Study Completion (ACTUAL)

April 1, 2012

Study Registration Dates

First Submitted

July 14, 2008

First Submitted That Met QC Criteria

July 14, 2008

First Posted (ESTIMATE)

July 16, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

April 29, 2013

Last Update Submitted That Met QC Criteria

April 19, 2013

Last Verified

April 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M10-301
  • 2007-007107-32 (EUDRACT_NUMBER)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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