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

Primary Purpose

Non Small Cell Lung Cancer

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Mapatumumab
Mapatumumab
Paclitaxel
Carboplatin
Sponsored by
Human Genome Sciences Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non Small Cell Lung Cancer focused on measuring Lung Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Birmingham Hematology and Oncology Associates, LLC
  • Desert Hematology Oncology Medical Group, Inc.
  • University of Colorado Health Sciences Center
  • Osceola Cancer Center
  • Palm Beach Cancer Institute
  • Rush University Medical Center
  • LaGrange Oncology Associates
  • Orchard Research, LLC
  • Kentuckiana Cancer Institute, PLLC
  • University of Maryland, Greenebaum Cancer Center
  • Chevy Chase Health Care
  • Hackensack University Medical Center
  • Medical University of South Carolina: Hollings Cancer Center
  • The Sarah Cannon Cancer Center
  • UT Health Science Center at San Antonio, Be Well Center
  • Fairfax-Northern Virginia Hematology Oncology, PC
  • Charite - Campus Mitte, Universitätsmedizin Berlin, Abteilung Onkologie und Hämatologie
  • Universitätsmedizin Berlin, Centrum für Innere Medizin
  • Asklepios Fachkliniken München-Gauting
  • Krankenhaus Großhansdorf
  • Krankenhaus Martha-Maria Halle-Dölau
  • Universitätsklinik Magdeburg, Klinik für Kardiologie, Angiologie und Pneumologie
  • Klinikum der Johannes-Gutenberg-Universität Mainz
  • Universitätsklinikum Mannheim, Chirurgische Klinik
  • Pius-Hospital
  • Paracelsus Klinik, Zentrum für Tumordiagnostik und -therapie
  • Fővárosi Önkormányzat Uzsoki Utcai Kórház
  • Országos Korányi TBC és Pulmonológiai Intezet
  • Debrecen University, Medical and Health Center, Dept of Oncology
  • Kenézy Gyula Kórház, Debrecen, Pulmonológia
  • Institutul Oncologic 'Prof Dr. Al Trestioreanu' Bucuresti
  • Institutul Oncologic 'Prof . Dr. I. Chiricuta' Cluj-Napoca
  • Spitalul Clinic Judetean Oradea, Oncology Department

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

A

B

C

Arm Description

Paclitaxel and carboplatin

Paclitaxel, carboplatin and Mapatumumab 10 mg/kg

Paclitaxel, carboplatin and Mapatumumab 30 mg/kg

Outcomes

Primary Outcome Measures

Objective response and Progression free survival

Secondary Outcome Measures

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.

Full Information

First Posted
December 20, 2007
Last Updated
August 1, 2013
Sponsor
Human Genome Sciences Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00583830
Brief Title
A Study of Mapatumumab in Combination With Paclitaxel and Carboplatin in Subjects With Non-small Cell Lung Cancer
Acronym
NSCLC
Official Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
February 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Human Genome Sciences Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non Small Cell Lung Cancer
Keywords
Lung Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
111 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Active Comparator
Arm Description
Paclitaxel and carboplatin
Arm Title
B
Arm Type
Experimental
Arm Description
Paclitaxel, carboplatin and Mapatumumab 10 mg/kg
Arm Title
C
Arm Type
Experimental
Arm Description
Paclitaxel, carboplatin and Mapatumumab 30 mg/kg
Intervention Type
Biological
Intervention Name(s)
Mapatumumab
Intervention Description
30 mg/kg IV (in the vein), on day 1 of each 21 day cycle
Intervention Type
Biological
Intervention Name(s)
Mapatumumab
Intervention Description
10 mg/kg IV (in the vein), on day 1 of each 21 day cycle
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Other Intervention Name(s)
Tax01, Paxene
Intervention Description
200 mg/m^2 IV (in the vein), on day 1 of each 21 day cycle
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Other Intervention Name(s)
Paraplatin
Intervention Description
AUC 6.0 mg min/ml IV (in the vein), on day 1 of each 21 day cycle
Primary Outcome Measure Information:
Title
Objective response and Progression free survival
Time Frame
6 cycles, or until disease progression or unacceptable toxicity develops
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
Birmingham Hematology and Oncology Associates, LLC
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35213
Country
United States
Facility Name
Desert Hematology Oncology Medical Group, Inc.
City
Rancho Mirage
State/Province
California
ZIP/Postal Code
92270
Country
United States
Facility Name
University of Colorado Health Sciences Center
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Osceola Cancer Center
City
Kissimmee
State/Province
Florida
ZIP/Postal Code
34741
Country
United States
Facility Name
Palm Beach Cancer Institute
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33401
Country
United States
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
LaGrange Oncology Associates
City
LaGrange
State/Province
Illinois
ZIP/Postal Code
60525
Country
United States
Facility Name
Orchard Research, LLC
City
Skokie
State/Province
Illinois
ZIP/Postal Code
60076
Country
United States
Facility Name
Kentuckiana Cancer Institute, PLLC
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
University of Maryland, Greenebaum Cancer Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Chevy Chase Health Care
City
Chevy Chase
State/Province
Maryland
ZIP/Postal Code
20815
Country
United States
Facility Name
Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Medical University of South Carolina: Hollings Cancer Center
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
The Sarah Cannon Cancer Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
UT Health Science Center at San Antonio, Be Well Center
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Fairfax-Northern Virginia Hematology Oncology, PC
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Facility Name
Charite - Campus Mitte, Universitätsmedizin Berlin, Abteilung Onkologie und Hämatologie
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Universitätsmedizin Berlin, Centrum für Innere Medizin
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Asklepios Fachkliniken München-Gauting
City
Gauting
ZIP/Postal Code
82131
Country
Germany
Facility Name
Krankenhaus Großhansdorf
City
Großhansdorf
ZIP/Postal Code
22927
Country
Germany
Facility Name
Krankenhaus Martha-Maria Halle-Dölau
City
Halle
ZIP/Postal Code
06120
Country
Germany
Facility Name
Universitätsklinik Magdeburg, Klinik für Kardiologie, Angiologie und Pneumologie
City
Magdeburg
ZIP/Postal Code
39120
Country
Germany
Facility Name
Klinikum der Johannes-Gutenberg-Universität Mainz
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Facility Name
Universitätsklinikum Mannheim, Chirurgische Klinik
City
Mannheim
ZIP/Postal Code
68167
Country
Germany
Facility Name
Pius-Hospital
City
Oldenburg
ZIP/Postal Code
26121
Country
Germany
Facility Name
Paracelsus Klinik, Zentrum für Tumordiagnostik und -therapie
City
Osnabrück
ZIP/Postal Code
49076
Country
Germany
Facility Name
Fővárosi Önkormányzat Uzsoki Utcai Kórház
City
Budapest
ZIP/Postal Code
1145
Country
Hungary
Facility Name
Országos Korányi TBC és Pulmonológiai Intezet
City
Budapest
ZIP/Postal Code
1529
Country
Hungary
Facility Name
Debrecen University, Medical and Health Center, Dept of Oncology
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Facility Name
Kenézy Gyula Kórház, Debrecen, Pulmonológia
City
Debrecen
ZIP/Postal Code
4043
Country
Hungary
Facility Name
Institutul Oncologic 'Prof Dr. Al Trestioreanu' Bucuresti
City
Bucuresti
ZIP/Postal Code
022328
Country
Romania
Facility Name
Institutul Oncologic 'Prof . Dr. I. Chiricuta' Cluj-Napoca
City
Cluj-Napoca
ZIP/Postal Code
400015
Country
Romania
Facility Name
Spitalul Clinic Judetean Oradea, Oncology Department
City
Oradea
ZIP/Postal Code
410032
Country
Romania

12. IPD Sharing Statement

Citations:
PubMed Identifier
24560012
Citation
von Pawel J, Harvey JH, Spigel DR, Dediu M, Reck M, Cebotaru CL, Humphreys RC, Gribbin MJ, Fox NL, Camidge DR. Phase II trial of mapatumumab, a fully human agonist monoclonal antibody to tumor necrosis factor-related apoptosis-inducing ligand receptor 1 (TRAIL-R1), in combination with paclitaxel and carboplatin in patients with advanced non-small-cell lung cancer. Clin Lung Cancer. 2014 May;15(3):188-196.e2. doi: 10.1016/j.cllc.2013.12.005. Epub 2013 Dec 27.
Results Reference
derived

Learn more about this trial

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

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