A Randomized, Double-Blind, Placebo-Controlled, Study of the Safety and Efficacy of Farletuzumab in Combination With a Platinum Containing Doublet in Chemotherapy-Naїve Subjects With Stage IV Adenocarcinoma of the Lung
Phase 2
18 Years
N/A
18 Years
N/A
Open (Enrolling)
Both
Adenocarcinoma of the Lung
Both
Adenocarcinoma of the Lung
Trial Information
A Randomized, Double-Blind, Placebo-Controlled, Study of the Safety and Efficacy of Farletuzumab in Combination With a Platinum Containing Doublet in Chemotherapy-Naїve Subjects With Stage IV Adenocarcinoma of the Lung
Inclusion Criteria:
- Histologically or cytologically confirmed adenocarcinoma of the lung classified as
stage IV
- Confirmed folate receptor-alpha (FRA) expression by IHC
- Measurable disease with at least one unidimensionally measurable lesion according to
RECIST criteria version 1.1 by CT or MRI scans (CT or MRI scans must have been
performed within 30 days prior to the first dose of farletuzumab or placebo)
- Must have received no prior chemotherapy, radiation therapy or surgery with curative
intent for adenocarcinoma of the lung
Exclusion Criteria:
- Subjects who have had previous chemotherapy for adenocarcinoma of the lung
- Prior surgery with curative intent for adenocarcinoma of the lung
- Prior radiotherapy for adenocarcinoma of the lung. (Prior treatment with local
radiotherapy for symptom control [i.e., palliative radiation with non-curative
intent] is permitted)
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Outcome Measure:
Progression-free survival (PFS) as determined by response evaluation criteria in solid tumors (RECIST) criteria version 1.1
Outcome Time Frame:
20 months from FPI (First Patient In)
Safety Issue:
No
Authority:
Australia: Department of Health and Ageing Therapeutic Goods Administration
Study ID:
MORAb-003-009
NCT ID:
NCT01218516
Start Date:
April 2011
Completion Date:
January 2015
Related Keywords:
- Adenocarcinoma of the Lung
- Adenocarcinoma
- Adenocarcinoma, Mucinous
- Lung Neoplasms
Name | Location |
|---|---|
| University of Texas Medical Branch | Galveston, Texas 77555-1329 |
| Virginia Mason Medical Center | Seattle, Washington 98111 |
| Broward General Medical Center | Fort Lauderdale, Florida 33316 |
| California Cancer Care, Inc. | Greenbrae, California 94904-2007 |
| Englewood Hospital and Medical Center | Englewood, New Jersey 07631 |
| Center for Hematology-Oncology | Boca Raton, Florida 33486 |
| Berkshire Hematology Oncology, PC | Pittsfield, Massachusetts 01201 |
| Queens Hospital Center | Jamaica, New York 11432 |
| University of Chicago Medical Center | Chicago, Illinois 60637 |
| Pacific Hematology Oncology Associates | San Francisco, California 94115 |
| Hematology and Oncology Specialists, LLC | New Orleans, Louisiana 70115 |
| Glendale Adventist Medical Center | Glendale, California 91206 |
| The Community Hospital | Munster, Indiana 46321 |
| Clinical Trials and Research Associates, Inc. | Montebello, California 60460 |
| Maryland Oncology Hematology, P.A. | Columbia, Maryland 21044 |
| Tennessee Oncology, PLLC | Clarksville, Tennessee 37043 |
| Rocky Mountain Cancer Centers, LLP | Denver, Colorado 80218 |
| Northwest Cancer Center | Houston, Texas 77042 |
| Cancer Care of North Florida | Lake City, Florida 32055 |
| Moores University of California San Diego Cancer Center | LA Jolla, California 92093 |
| Central Coast Medical Oncology | Santa Maria, California 93454 |
| National Cancer Institute | Bethesda, Maryland 20892-1922 |
| Florida Cancer Institute-New Hope | Hudson, Florida 34667 |
| Kentucky Cancer Center | Hazard, Kentucky 41701 |
| Willamette Valley Cancer Institute and Research Center | Springfield, Oregon 97477 |
| Texas Oncology - Tyler | Tyler, Texas 75702 |
| Houston Cancer Institute | Houston, Texas 77055 |
| Cancer Care Associates of Fresno Medical Group, Inc. | Fresno, California 93720 |
| Rockwood Cancer Treatment Center | Spokane, Washington 99204 |
| Medical Specialists of the Palm Beaches | Lake Worth, Florida 33454 |
| Gettysburg Cancer Center | Gettysburg, Pennsylvania 17325 |
| Virginia Cancer Specialists, PC | Fairfax, Virginia 22031 |
| MD Anderson Cancer Center-Orlando | Orlando, Florida 32806 |
| Deaconess Clinic Downtown | Evansville, Indiana 47713 |
| Texas Oncology - Bedford | Bedford, Texas 76022 |
| Arizona Center for Hematology Oncology | Glendale, Arizona 85306 |
| Texas Oncology - Waco | Waco, Texas 76712 |
| Ironwood Cancer and Research Center | Chandler, Arizona 85224 |
| Medical Oncology Associates, PS | Spokane, Washington 99208 |
| Delta Hematology Oncology Associates, PC | Portsmouth, Virginia 23704 |
| Providence Health System | Beverly Hills, California 90210-5501 |
| Medical Oncology Hematology | Gilroy, California 95020 |
| Wilshire Medical Oncology Group | La Verne, California 91750 |
| North Country Oncology-Hematology | Oceanside, California 92056 |
| Hematology Oncology Associates, P.C. | Stamford, Connecticut 06902-3628 |
| Ocala Oncology Center, PL | Ocala, Florida 34474 |
| University Hematology Oncology, Inc. | Centralia, Illinois 62801 |
| Baptist Health System, Inc. | Lexington, Kentucky 40503 |
| Christus Saint Frances, Cabrini Hospital, Cabrini Cancer Center | Alexandria, Louisiana 71301 |
| Detroit Clinical Research Center | Farmington Hills, Michigan 48336 |
| Syracuse Veterns Affairs Medical Center | Syracuse, New York 13210 |
| St. Luke's Cancer Center Associates | Bethlehem, Pennsylvania 18015 |
| Texas Oncology - Plano East | Plano, Texas 75075-7787 |
| Cancer Team Bellin Health | Green Bay, Wisconsin 54313 |
