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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
145

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Progression Free Survival (PFS)
Time Frame: Disease Progression
Disease Progression

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AbbVie (prior sponsor, Abbott)

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2008

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2012

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 14, 2008

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 14, 2008

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 16, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 29, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 19, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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