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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
Open (Enrolling)
Both
Adenocarcinoma of the Lung

Thank you

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 BranchGalveston, Texas  77555-1329
Virginia Mason Medical CenterSeattle, Washington  98111
Broward General Medical CenterFort Lauderdale, Florida  33316
California Cancer Care, Inc.Greenbrae, California  94904-2007
Englewood Hospital and Medical CenterEnglewood, New Jersey  07631
Center for Hematology-OncologyBoca Raton, Florida  33486
Berkshire Hematology Oncology, PCPittsfield, Massachusetts  01201
Queens Hospital CenterJamaica, New York  11432
University of Chicago Medical CenterChicago, Illinois  60637
Pacific Hematology Oncology AssociatesSan Francisco, California  94115
Hematology and Oncology Specialists, LLCNew Orleans, Louisiana  70115
Glendale Adventist Medical CenterGlendale, California  91206
The Community HospitalMunster, Indiana  46321
Clinical Trials and Research Associates, Inc.Montebello, California  60460
Maryland Oncology Hematology, P.A.Columbia, Maryland  21044
Tennessee Oncology, PLLCClarksville, Tennessee  37043
Rocky Mountain Cancer Centers, LLPDenver, Colorado  80218
Northwest Cancer CenterHouston, Texas  77042
Cancer Care of North FloridaLake City, Florida  32055
Moores University of California San Diego Cancer CenterLA Jolla, California  92093
Central Coast Medical OncologySanta Maria, California  93454
National Cancer InstituteBethesda, Maryland  20892-1922
Florida Cancer Institute-New HopeHudson, Florida  34667
Kentucky Cancer CenterHazard, Kentucky  41701
Willamette Valley Cancer Institute and Research CenterSpringfield, Oregon  97477
Texas Oncology - TylerTyler, Texas  75702
Houston Cancer InstituteHouston, Texas  77055
Cancer Care Associates of Fresno Medical Group, Inc.Fresno, California  93720
Rockwood Cancer Treatment CenterSpokane, Washington  99204
Medical Specialists of the Palm BeachesLake Worth, Florida  33454
Gettysburg Cancer CenterGettysburg, Pennsylvania  17325
Virginia Cancer Specialists, PCFairfax, Virginia  22031
MD Anderson Cancer Center-OrlandoOrlando, Florida  32806
Deaconess Clinic DowntownEvansville, Indiana  47713
Texas Oncology - BedfordBedford, Texas  76022
Arizona Center for Hematology OncologyGlendale, Arizona  85306
Texas Oncology - WacoWaco, Texas  76712
Ironwood Cancer and Research CenterChandler, Arizona  85224
Medical Oncology Associates, PSSpokane, Washington  99208
Delta Hematology Oncology Associates, PCPortsmouth, Virginia  23704
Providence Health SystemBeverly Hills, California  90210-5501
Medical Oncology HematologyGilroy, California  95020
Wilshire Medical Oncology GroupLa Verne, California  91750
North Country Oncology-HematologyOceanside, California  92056
Hematology Oncology Associates, P.C.Stamford, Connecticut  06902-3628
Ocala Oncology Center, PLOcala, Florida  34474
University Hematology Oncology, Inc.Centralia, Illinois  62801
Baptist Health System, Inc.Lexington, Kentucky  40503
Christus Saint Frances, Cabrini Hospital, Cabrini Cancer CenterAlexandria, Louisiana  71301
Detroit Clinical Research CenterFarmington Hills, Michigan  48336
Syracuse Veterns Affairs Medical CenterSyracuse, New York  13210
St. Luke's Cancer Center AssociatesBethlehem, Pennsylvania  18015
Texas Oncology - Plano EastPlano, Texas  75075-7787
Cancer Team Bellin HealthGreen Bay, Wisconsin  54313