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

Phase 2

Completed

• Conditions: Non Small Cell Lung Cancer
• Interventions: Drug: Paclitaxel; Biological: Mapatumumab; Drug: Carboplatin

• Registration Number: NCT00583830
• Lead Sponsor: Human Genome Sciences Inc.

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2007-01
• Study First Submitted: 2007-12-20
• Study First Submitted QC: 2007-12-20
• Study First Posted: 2007-12-31
• Primary Completion: 2010-11
• Study Completion: 2011-02
• Disposition First Submitted: 2011-03-30
• Disposition First Submitted QC: 2011-04-11
• Disposition First Posted: 2011-04-25
• Status Verified: 2013-08
• Last Update Submitted: 2013-08-01
• Last Update Posted: 2013-08-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 111

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	Paclitaxel	Paclitaxel and carboplatin
A	Carboplatin	Paclitaxel and carboplatin
B	Mapatumumab	Paclitaxel, carboplatin and Mapatumumab 10 mg/kg
B	Paclitaxel	Paclitaxel, carboplatin and Mapatumumab 10 mg/kg
C	Mapatumumab	Paclitaxel, carboplatin and Mapatumumab 30 mg/kg
B	Carboplatin	Paclitaxel, carboplatin and Mapatumumab 10 mg/kg
C	Paclitaxel	Paclitaxel, carboplatin and Mapatumumab 30 mg/kg
C	Carboplatin	Paclitaxel, carboplatin and Mapatumumab 30 mg/kg

Primary Outcome Measures

Name	Time	Method
Objective response and Progression free survival	6 cycles, or until disease progression or unacceptable toxicity develops

Secondary Outcome Measures

Name	Time	Method
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.	6 cycles, or until disease progression or unacceptable toxicity develops

Trial Locations

Locations (33)

Hackensack University Medical Center; 🇺🇸 Hackensack, New Jersey, United States

Desert Hematology Oncology Medical Group, Inc.; 🇺🇸 Rancho Mirage, California, United States

Klinikum der Johannes-Gutenberg-Universität Mainz; 🇩🇪 Mainz, Germany

Krankenhaus Martha-Maria Halle-Dölau; 🇩🇪 Halle, Germany

Osceola Cancer Center; 🇺🇸 Kissimmee, Florida, United States

Palm Beach Cancer Institute; 🇺🇸 West Palm Beach, Florida, United States

Fairfax-Northern Virginia Hematology Oncology, PC; 🇺🇸 Fairfax, Virginia, United States

Fővárosi Önkormányzat Uzsoki Utcai Kórház; 🇭🇺 Budapest, Hungary

Krankenhaus Großhansdorf; 🇩🇪 Großhansdorf, Germany

Paracelsus Klinik, Zentrum für Tumordiagnostik und -therapie; 🇩🇪 Osnabrück, Germany

Debrecen University, Medical and Health Center, Dept of Oncology; 🇭🇺 Debrecen, Hungary

Institutul Oncologic 'Prof Dr. Al Trestioreanu' Bucuresti; 🇷🇴 Bucuresti, Romania

Universitätsklinikum Mannheim, Chirurgische Klinik; 🇩🇪 Mannheim, Germany

Országos Korányi TBC és Pulmonológiai Intezet; 🇭🇺 Budapest, Hungary

Kenézy Gyula Kórház, Debrecen, Pulmonológia; 🇭🇺 Debrecen, Hungary

Institutul Oncologic 'Prof . Dr. I. Chiricuta' Cluj-Napoca; 🇷🇴 Cluj-Napoca, Romania

Spitalul Clinic Judetean Oradea, Oncology Department; 🇷🇴 Oradea, Romania

Charite - Campus Mitte, Universitätsmedizin Berlin, Abteilung Onkologie und Hämatologie; 🇩🇪 Berlin, Germany

The Sarah Cannon Cancer Center; 🇺🇸 Nashville, Tennessee, United States

UT Health Science Center at San Antonio, Be Well Center; 🇺🇸 San Antonio, Texas, United States

LaGrange Oncology Associates; 🇺🇸 LaGrange, Illinois, United States

Birmingham Hematology and Oncology Associates, LLC; 🇺🇸 Birmingham, Alabama, United States

Orchard Research, LLC; 🇺🇸 Skokie, Illinois, United States

University of Maryland, Greenebaum Cancer Center; 🇺🇸 Baltimore, Maryland, United States

Rush University Medical Center; 🇺🇸 Chicago, Illinois, United States

Chevy Chase Health Care; 🇺🇸 Chevy Chase, Maryland, United States

Universitätsmedizin Berlin, Centrum für Innere Medizin; 🇩🇪 Berlin, Germany

Asklepios Fachkliniken München-Gauting; 🇩🇪 Gauting, Germany

Universitätsklinik Magdeburg, Klinik für Kardiologie, Angiologie und Pneumologie; 🇩🇪 Magdeburg, Germany

Pius-Hospital; 🇩🇪 Oldenburg, Germany

Kentuckiana Cancer Institute, PLLC; 🇺🇸 Louisville, Kentucky, United States

University of Colorado Health Sciences Center; 🇺🇸 Aurora, Colorado, United States

Medical University of South Carolina: Hollings Cancer Center; 🇺🇸 Charleston, South Carolina, United States