A Study of Mapatumumab in Combination With Paclitaxel and Carboplatin in Subjects With Non-Small Cell Lung Cancer - Full Text View

Sponsored by:	Human Genome Sciences
Information provided by:	Human Genome Sciences
ClinicalTrials.gov Identifier:	NCT00583830

Purpose

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).

Condition	Intervention	Phase
Non Small Cell Lung Cancer	Biological: Mapatumumab Drug: Paclitaxel Drug: Carboplatin	Phase II

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Carboplatin Paclitaxel Mapatumumab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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)

Further study details as provided by Human Genome Sciences:

Primary Outcome Measures:

Objective response and Progression free survival [ Time Frame: 6 cycles, or until disease progression or unacceptable toxicity develops ] [ Designated as safety issue: No ]

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. [ Time Frame: 6 cycles, or until disease progression or unacceptable toxicity develops ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	105
Study Start Date:	November 2007
Estimated Study Completion Date:	January 2010
Estimated Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Active Comparator Paclitaxel and carboplatin	Drug: Paclitaxel 200 mg/m^2 IV (in the vein), on day 1 of each 21 day cycle Drug: Carboplatin AUC 6.0 mg min/ml IV (in the vein), on day 1 of each 21 day cycle
B: Experimental Paclitaxel, carboplatin and Mapatumumab 10 mg/kg	Biological: 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 Drug: Carboplatin AUC 6.0 mg min/ml IV (in the vein), on day 1 of each 21 day cycle
C: Experimental Paclitaxel, carboplatin and Mapatumumab 30 mg/kg	Biological: Mapatumumab 30 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 Drug: Carboplatin AUC 6.0 mg min/ml IV (in the vein), on day 1 of each 21 day cycle

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00583830

Show 33 Study Locations

Sponsors and Collaborators

Human Genome Sciences

Investigators

Study Chair:

Adrianne Kelly, MD

Human Genome Sciences, Inc

More Information

Responsible Party:	Human Genome Sciences, Inc ( Dan Odenheimer )
Study ID Numbers:	HGS1012-C1072
Study First Received:	December 20, 2007
Last Updated:	October 3, 2008
ClinicalTrials.gov Identifier:	NCT00583830
Health Authority:	United States: Food and Drug Administration; Germany: Paul-Ehrlich-Institut; Hungary: National Institute of Pharmacy; Romania: National Medicines Agency

Keywords provided by Human Genome Sciences:

Lung Cancer

Study placed in the following topic categories:

Thoracic Neoplasms
Non-small cell lung cancer
Respiratory Tract Diseases
Paclitaxel
Lung Neoplasms

Lung Diseases
Carboplatin
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents

Therapeutic Uses
Mitosis Modulators
Tubulin Modulators
Antimitotic Agents
Antineoplastic Agents, Phytogenic
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009