A Study of Mapatumumab in Combination With Paclitaxel and Carboplatin in Subjects With Non-small Cell Lung Cancer (NSCLC)

August 1, 2013 updated by: Human Genome Sciences Inc.

A Phase 2, Randomized, Multi-Center, Open-Label Study to Evaluate the Efficacy and Safety of Mapatumumab in Combination With Carboplatin and Paclitaxel as First Line Therapy in Subjects With Advanced Non-Small Cell Lung Cancer (NSCLC)

The purpose of this study is to evaluate the efficacy (disease response) and safety of mapatumumab in combination with carboplatin and paclitaxel as first line therapy in subjects with advanced non-small cell lung cancer (NSCLC).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

111

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

  • Germany
      • Berlin, Germany, 10117
        • Charite - Campus Mitte, Universitätsmedizin Berlin, Abteilung Onkologie und Hämatologie
      • Berlin, Germany, 10117
        • Universitätsmedizin Berlin, Centrum für Innere Medizin
      • Gauting, Germany, 82131
        • Asklepios Fachkliniken München-Gauting
      • Großhansdorf, Germany, 22927
        • Krankenhaus Großhansdorf
      • Halle, Germany, 06120
        • Krankenhaus Martha-Maria Halle-Dölau
      • Magdeburg, Germany, 39120
        • Universitätsklinik Magdeburg, Klinik für Kardiologie, Angiologie und Pneumologie
      • Mainz, Germany, 55131
        • Klinikum der Johannes-Gutenberg-Universität Mainz
      • Mannheim, Germany, 68167
        • Universitätsklinikum Mannheim, Chirurgische Klinik
      • Oldenburg, Germany, 26121
        • Pius-Hospital
      • Osnabrück, Germany, 49076
        • Paracelsus Klinik, Zentrum für Tumordiagnostik und -therapie
  • Hungary
      • Budapest, Hungary, 1145
        • Fövárosi Önkormányzat uzsoki utcai Kórház
      • Budapest, Hungary, 1529
        • Orszagos Koranyi Tbc es Pulmonologiai Intezet
      • Debrecen, Hungary, 4032
        • Debrecen University, Medical and Health Center, Dept of Oncology
      • Debrecen, Hungary, 4043
        • Kenézy Gyula Kórház, Debrecen, Pulmonológia
  • Romania
      • Bucuresti, Romania, 022328
        • Institutul Oncologic 'Prof Dr. Al Trestioreanu' Bucuresti
      • Cluj-Napoca, Romania, 400015
        • Institutul Oncologic 'Prof . Dr. I. Chiricuta' Cluj-Napoca
      • Oradea, Romania, 410032
        • Spitalul Clinic Judetean Oradea, Oncology Department
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35213
        • Birmingham Hematology and Oncology Associates, LLC
    • California
      • Rancho Mirage, California, United States, 92270
        • Desert Hematology Oncology Medical Group, Inc.
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Health Sciences Center
    • Florida
      • Kissimmee, Florida, United States, 34741
        • Osceola Cancer Center
      • West Palm Beach, Florida, United States, 33401
        • Palm Beach Cancer Institute
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush University Medical Center
      • LaGrange, Illinois, United States, 60525
        • LaGrange Oncology Associates
      • Skokie, Illinois, United States, 60076
        • Orchard Research, LLC
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Kentuckiana Cancer Institute, PLLC
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • University of Maryland, Greenebaum Cancer Center
      • Chevy Chase, Maryland, United States, 20815
        • Chevy Chase Health Care
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Hackensack University Medical Center
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina: Hollings Cancer Center
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • The Sarah Cannon Cancer Center
    • Texas
      • San Antonio, Texas, United States, 78229
        • UT Health Science Center at San Antonio, Be Well Center
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Fairfax-Northern Virginia Hematology Oncology, PC

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:

  • Patients with histologically or cytologically confirmed stage IIIB or stage IV advanced primary non-small cell lung cancinoma
  • Age 18 years or older

Exclusion Criteria:

  • Received investigational (not yet approved by a regulatory authority) or non-investigational agent to treat Lung Cancer
  • Received radiation therapy within 4 weeks before randomization
  • Major surgery within 4 weeks before randomization
  • Minor surgery within 2 weeks before randomizaiton
  • Systemic steroids within 1 week before randomization
  • Any grade 2 or greater neuropathy
  • History of severe (Grade 4) hypersensitivity reaction to products containing Cremophor EL (cyclosporine, teniposide)
  • History of any infection requiring hospitalization or antibiotics within 2 weeks before randomization
  • Known brain or spinal cord metastases
  • History of other cancers within 5 years before randomization
  • Known HIV, hepatitis-B or hepatitis-C infection
  • Pregnant or breast-feeding women
  • Previously treated with Mapatumumab

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: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: A
Paclitaxel and carboplatin
Drug: Paclitaxel
200 mg/m^2 IV (in the vein), on day 1 of each 21 day cycle
Other Names:
  • Paxene
  • Tax01
Drug: Carboplatin
AUC 6.0 mg min/ml IV (in the vein), on day 1 of each 21 day cycle
Other Names:
  • Paraplatin
EXPERIMENTAL: B
Paclitaxel, carboplatin and Mapatumumab 10 mg/kg
Drug: Paclitaxel
200 mg/m^2 IV (in the vein), on day 1 of each 21 day cycle
Other Names:
  • Paxene
  • Tax01
Drug: Carboplatin
AUC 6.0 mg min/ml IV (in the vein), on day 1 of each 21 day cycle
Other Names:
  • Paraplatin
Biological: Mapatumumab
30 mg/kg IV (in the vein), on day 1 of each 21 day cycle
Biological: Mapatumumab
10 mg/kg IV (in the vein), on day 1 of each 21 day cycle
EXPERIMENTAL: C
Paclitaxel, carboplatin and Mapatumumab 30 mg/kg
Drug: Paclitaxel
200 mg/m^2 IV (in the vein), on day 1 of each 21 day cycle
Other Names:
  • Paxene
  • Tax01
Drug: Carboplatin
AUC 6.0 mg min/ml IV (in the vein), on day 1 of each 21 day cycle
Other Names:
  • Paraplatin
Biological: Mapatumumab
30 mg/kg IV (in the vein), on day 1 of each 21 day cycle
Biological: Mapatumumab
10 mg/kg IV (in the vein), on day 1 of each 21 day cycle

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Objective response and Progression free survival
Time Frame: 6 cycles, or until disease progression or unacceptable toxicity develops
6 cycles, or until disease progression or unacceptable toxicity develops

Secondary Outcome Measures

Outcome Measure
Time Frame
Disease control; Overall survival; Response duration and time to response in responders; Frequency and severity of treatment-emergent adverse events; Laboratory parameters; and Serum mapatumumab concentrations for use in a PK analysis.
Time Frame: 6 cycles, or until disease progression or unacceptable toxicity develops
6 cycles, or until disease progression or unacceptable toxicity develops

Collaborators and Investigators

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

Sponsor

Human Genome Sciences 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

January 1, 2007

Primary Completion (ACTUAL)

November 1, 2010

Study Completion (ACTUAL)

February 1, 2011

Study Registration Dates

First Submitted

December 20, 2007

First Submitted That Met QC Criteria

December 20, 2007

First Posted (ESTIMATE)

December 31, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

August 8, 2013

Last Update Submitted That Met QC Criteria

August 1, 2013

Last Verified

August 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HGS1012-C1072

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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