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)
Phase 2
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Non Small Cell Lung Cancer
Both
Non Small Cell Lung Cancer
Trial Information
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)
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Objective response and Progression free survival
Outcome Time Frame:
6 cycles, or until disease progression or unacceptable toxicity develops
Safety Issue:
No
Principal Investigator
GSK Clinical Trials
Investigator Role:
Study Director
Investigator Affiliation:
GlaxoSmithKline
Authority:
United States: Food and Drug Administration
Study ID:
HGS1012-C1072
NCT ID:
NCT00583830
Start Date:
January 2007
Completion Date:
February 2011
Related Keywords:
- Non Small Cell Lung Cancer
- Lung Cancer
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
Name | Location |
|---|---|
| Rush University Medical Center | Chicago, Illinois 60612-3824 |
| Hackensack University Medical Center | Hackensack, New Jersey 07601 |
| Palm Beach Cancer Institute | West Palm Beach, Florida 33401 |
| University of Colorado Health Sciences Center | Denver, Colorado 80262 |
| Osceola Cancer Center | Kissimmee, Florida 34741 |
| The Sarah Cannon Cancer Center | Nashville, Tennessee 37203 |
| University of Maryland, Greenebaum Cancer Center | Baltimore, Maryland 21201 |
| Lagrange Oncology Associates | La Grange, Illinois 60525 |
| Kentuckiana Cancer Institute, PLLC | Louisville, Kentucky 40202 |
| Desert Hematology Oncology Medical Group, Inc. | Rancho Mirage, California 92270 |
| Birmingham Hematology and Oncology Associates, LLC | Birmingham, Alabama 35235 |
| Fairfax-Northern Virginia Hematology Oncology, PC | Fairfax, Virginia 22031 |
| Orchard Research, LLC | Skokie, Illinois 60076 |
| Chevy Chase Health Care | Chevy Chase, Maryland 20815 |
| Medical University of South Carolina: Hollings Cancer Center | Charleston, South Carolina 29425 |
| UT Health Science Center at San Antonio, Be Well Center | San Antonio, Texas 78229 |
