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

Non Small Cell Lung Cancer Clinical Trial

— 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00583830
• Other study ID #: HGS1012-C1072
• Status: Completed
• Phase: Phase 2
• First received: December 20, 2007
• Last updated: August 1, 2013
• Start date: January 2007
• Est. completion date: February 2011

Study information

• Verified date: August 2013
• Source: Human Genome Sciences Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationGermany: Paul-Ehrlich-InstitutHungary: National Institute of PharmacyRomania: National Medicines Agency
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 111
• Est. completion date: February 2011
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non Small Cell Lung Cancer

Intervention

Biological:
• Mapatumumab
30 mg/kg IV (in the vein), on day 1 of each 21 day cycle
• Mapatumumab
10 mg/kg IV (in the vein), on day 1 of each 21 day cycle

Drug:
• Paclitaxel
200 mg/m^2 IV (in the vein), on day 1 of each 21 day cycle
• Carboplatin
AUC 6.0 mg min/ml IV (in the vein), on day 1 of each 21 day cycle

Locations

Country	Name	City	State
Germany	Charite - Campus Mitte, Universitätsmedizin Berlin, Abteilung Onkologie und Hämatologie	Berlin
Germany	Universitätsmedizin Berlin, Centrum für Innere Medizin	Berlin
Germany	Asklepios Fachkliniken München-Gauting	Gauting
Germany	Krankenhaus Großhansdorf	Großhansdorf
Germany	Krankenhaus Martha-Maria Halle-Dölau	Halle
Germany	Universitätsklinik Magdeburg, Klinik für Kardiologie, Angiologie und Pneumologie	Magdeburg
Germany	Klinikum der Johannes-Gutenberg-Universität Mainz	Mainz
Germany	Universitätsklinikum Mannheim, Chirurgische Klinik	Mannheim
Germany	Pius-Hospital	Oldenburg
Germany	Paracelsus Klinik, Zentrum für Tumordiagnostik und -therapie	Osnabrück
Hungary	Fovárosi Önkormányzat Uzsoki Utcai Kórház	Budapest
Hungary	Országos Korányi TBC és Pulmonológiai Intezet	Budapest
Hungary	Debrecen University, Medical and Health Center, Dept of Oncology	Debrecen
Hungary	Kenézy Gyula Kórház, Debrecen, Pulmonológia	Debrecen
Romania	Institutul Oncologic 'Prof Dr. Al Trestioreanu' Bucuresti	Bucuresti
Romania	Institutul Oncologic 'Prof . Dr. I. Chiricuta' Cluj-Napoca	Cluj-Napoca
Romania	Spitalul Clinic Judetean Oradea, Oncology Department	Oradea
United States	University of Colorado Health Sciences Center	Aurora	Colorado
United States	University of Maryland, Greenebaum Cancer Center	Baltimore	Maryland
United States	Birmingham Hematology and Oncology Associates, LLC	Birmingham	Alabama
United States	Medical University of South Carolina: Hollings Cancer Center	Charleston	South Carolina
United States	Chevy Chase Health Care	Chevy Chase	Maryland
United States	Rush University Medical Center	Chicago	Illinois
United States	Fairfax-Northern Virginia Hematology Oncology, PC	Fairfax	Virginia
United States	Hackensack University Medical Center	Hackensack	New Jersey
United States	Osceola Cancer Center	Kissimmee	Florida
United States	LaGrange Oncology Associates	LaGrange	Illinois
United States	Kentuckiana Cancer Institute, PLLC	Louisville	Kentucky
United States	The Sarah Cannon Cancer Center	Nashville	Tennessee
United States	Desert Hematology Oncology Medical Group, Inc.	Rancho Mirage	California
United States	UT Health Science Center at San Antonio, Be Well Center	San Antonio	Texas
United States	Orchard Research, LLC	Skokie	Illinois
United States	Palm Beach Cancer Institute	West Palm Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Human Genome Sciences Inc.

Countries where clinical trial is conducted

United States,  Germany,  Hungary,  Romania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective response and Progression free survival		6 cycles, or until disease progression or unacceptable toxicity develops	No
Secondary	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	Yes