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):
Human Genome Sciences Inc.
ClinicalTrials.gov Identifier:
NCT00583830
First received: December 20, 2007
Last updated: August 1, 2013
Last verified: August 2013
  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:


Further study details as provided by Human Genome Sciences Inc.:

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  Show 33 Study Locations
Sponsors and Collaborators
Human Genome Sciences Inc.
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided by Human Genome Sciences Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Human Genome Sciences Inc.
ClinicalTrials.gov Identifier: NCT00583830     History of Changes
Other Study ID Numbers: HGS1012-C1072
Study First Received: December 20, 2007
Last Updated: August 1, 2013
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 Inc.:
Lung Cancer

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

ClinicalTrials.gov processed this record on October 01, 2014