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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline ( Human Genome Sciences Inc., a GSK Company )
ClinicalTrials.gov Identifier:
NCT00583830
First received: December 20, 2007
Last updated: October 29, 2012
Last verified: October 2012
History of Changes
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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)

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer
U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

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 ]

Enrollment: 111
Study Start Date: January 2007
Study Completion Date: February 2011
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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:
  • Tax01
  • Paxene
Drug: Carboplatin
AUC 6.0 mg min/ml IV (in the vein), on day 1 of each 21 day cycle
Other Name: Paraplatin
Experimental: B
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
Other Names:
  • Tax01
  • Paxene
Drug: Carboplatin
AUC 6.0 mg min/ml IV (in the vein), on day 1 of each 21 day cycle
Other Name: Paraplatin
Experimental: C
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
Other Names:
  • Tax01
  • Paxene
Drug: Carboplatin
AUC 6.0 mg min/ml IV (in the vein), on day 1 of each 21 day cycle
Other Name: Paraplatin

  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 Inc., a GSK Company
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline ( Human Genome Sciences Inc., a GSK Company )
ClinicalTrials.gov Identifier: NCT00583830     History of Changes
Other Study ID Numbers: HGS1012-C1072
Study First Received: December 20, 2007
Last Updated: October 29, 2012
Health Authority: United States: Food and Drug Administration
Germany: Paul-Ehrlich-Institut
Hungary: National Institute of Pharmacy
Romania: National Medicines Agency

Keywords provided by GlaxoSmithKline:
Lung Cancer

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carboplatin
Paclitaxel
 Antibodies, Monoclonal
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 19, 2013