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Trial record 1 of 1 for:    MORAb-003-009
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A Safety and Efficacy Study of Farletuzumab in Subjects With Adenocarcinoma of the Lung

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01218516
First Posted: October 11, 2010
Last Update Posted: June 20, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Morphotek
  Purpose
The primary objective of this study is to compare the effect of farletuzumab versus placebo in combination with either a platinum agent (carboplatin) with paclitaxel or a platinum agent (carboplatin or cisplatin) with pemetrexed followed by farletuzumab or placebo on investigator-assessed progression free survival (PFS) as determined by Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 or definitive clinical disease progression (eg, new occurrence of positive fluid cytology) in chemotherapynaive participants with folate receptoralpha (FRA)-expressing Stage IV adenocarcinoma of the lung.

Condition Intervention Phase
Adenocarcinoma of the Lung Biological: Farletuzumab Other: Placebo Drug: Carboplatin Drug: Paclitaxel Drug: Pemetrexed Drug: Cisplatin Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Study of the Safety and Efficacy of Farletuzumab in Combination With a Platinum Containing Doublet in Chemotherapy-Naive Subjects With Stage IV Adenocarcinoma of the Lung

Resource links provided by NLM:


Further study details as provided by Morphotek:

Primary Outcome Measures:
  • Progression-free survival (PFS) [ Time Frame: From date of first administration of study drug up to 6 month follow-up from randomization of the last participant i.e. cut-off date 15 Dec 2012 for primary analysis and cut-off date of 1 Nov 2013 or up to approximately 29 months for final analysis ]

Secondary Outcome Measures:
  • Overall Response rate (ORR) [ Time Frame: From Day 1 until documented radiographic progression, other protocol-approved measures of disease progression, withdrawal by participant, death due to any cause, or cut-off date of 1 Nov 2013 i.e. up to approximately 29 months for final analysis ]
  • Duration of Response (DR) [ Time Frame: From the first documentation of objective response (CR or PR) to the first documentation of disease progression, death due to any cause, or cut-off date of 1 Nov 2013 i.e. up to approximately 29 months for final analysis ]
  • Overall Survival (OS) [ Time Frame: From the date of randomization to the date of death due to any cause or up to cut-off date of 1 Nov 2013 (up to approximately 29 months) for final analysis ]
  • Number of participants with Treatment emergent adverse events (TEAEs) and Treatment emergent Serious adverse events (SAEs) [ Time Frame: For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013 i.e. up to approximately 29 months for final analysis ]

Enrollment: 130
Study Start Date: April 2011
Study Completion Date: November 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Farletuzumab plus Chemotherapy
During Combination Therapy, farletuzumab will be given with a protocol-approved platinum doublet (either carboplatin/paclitaxel, carboplatin/pemetrexed, or cisplatin/pemetrexed) for at least 4, but not more than 6, cycles. Participants who experience clinical benefit from the Combination Therapy will enter the Monotherapy Phase and receive farletuzumab as monotherapy until disease progression.
Biological: Farletuzumab

Combination Therapy: Farletuzumab 7.5 mg/kg will be administered intravenously on Cycle 1, Week 1 and Cycle 1, Week 2 (loading dose). Beginning on Cycle 2, Week 1, farletuzumab (7.5 mg/kg) will be administered intravenously on Week 1 of all additional cycles.

Monotherapy: Farletuzumab 7.5 mg/kg will be administered intravenously on Week 1 of every 3-week cycle until disease progression.

Other Name: MORAb-003
Drug: Carboplatin
Carboplatin will be administered intravenously to achieve area under the serum concentration-time curve of 5 to 6 mg/mL^min [AUC5-6]
Drug: Paclitaxel
Paclitaxel 200 mg/m2 will be administered intravenously
Drug: Pemetrexed
Pemetrexed 500 mg/m2 will be administered intravenously
Drug: Cisplatin
Cisplatin 75 mg/m2 will be administered intravenously
Placebo Comparator: Placebo plus Chemotherapy
During Combination Therapy, placebo will be given with a protocol-approved platinum doublet (either carboplatin/paclitaxel, carboplatin/pemetrexed, or cisplatin/pemetrexed) for at least 4, but not more than 6, cycles. Participants who experience clinical benefit from the Combination Therapy will enter the Monotherapy Phase and receive placebo as monotherapy until disease progression.
Other: Placebo

Combination Therapy: Placebo will be administered intravenously on Cycle 1, Week 1 and Cycle 1, Week 2 (loading dose). Beginning on Cycle 2, Week 1, placebo will be administered IV on Week 1 of all additional cycles.

Monotherapy: Placebo will be administered intravenously on Week 1 of every 3-week cycle until disease progression.

Drug: Carboplatin
Carboplatin will be administered intravenously to achieve area under the serum concentration-time curve of 5 to 6 mg/mL^min [AUC5-6]
Drug: Paclitaxel
Paclitaxel 200 mg/m2 will be administered intravenously
Drug: Pemetrexed
Pemetrexed 500 mg/m2 will be administered intravenously
Drug: Cisplatin
Cisplatin 75 mg/m2 will be administered intravenously

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01218516


  Hide Study Locations
Locations
United States, Arizona
Ironwood Cancer and Research Center
Chandler, Arizona, United States, 85224
Arizona Center for Hematology Oncology
Glendale, Arizona, United States, 85306-4666
United States, California
Providence Health System
Beverly Hills, California, United States, 90210-5501
Cancer Care Associates of Fresno Medical Group, Inc.
Fresno, California, United States, 93720
Medical Oncology Hematology
Gilroy, California, United States, 95020
California Cancer Care, Inc.
Greenbrae, California, United States, 94904
Moores University of California San Diego Cancer Center
La Jolla, California, United States, 92093
Wilshire Medical Oncology Group
La Verne, California, United States, 91750
Glendale Adventist Medical Center
Los Angeles, California, United States, 90025
Clinical Trials and Research Associates, Inc.
Montebello, California, United States, 90640
North Country Oncology-Hematology
Oceanside, California, United States, 92056
Pacific Hematology Oncology Associates
San Francisco, California, United States, 94115
Central Coast Medical Oncology
Santa Maria, California, United States, 93454
United States, Colorado
Rocky Mountain Cancer Centers, LLP
Denver, Colorado, United States, 80218-1237
United States, Connecticut
Hematology Oncology Associates, P.C.
Stamford, Connecticut, United States, 06902-3628
United States, Florida
Center for Hematology-Oncology
Boca Raton, Florida, United States, 33486
Medical Specialists of the Palm Beaches
Deerfield Beach, Florida, United States, 33441
Broward General Medical Center
Fort Lauderdale, Florida, United States, 33316
Cancer Care of North Florida
Lake City, Florida, United States, 32024
Florida Cancer Institute-New Hope
New Port Richey, Florida, United States, 34655
Ocala Oncology Center, PL
Ocala, Florida, United States, 34474
MD Anderson Cancer Center-Orlando
Orlando, Florida, United States, 32806
United States, Illinois
University Hematology Oncology, Inc.
Centralia, Illinois, United States, 62801
University of Chicago Medical Center
Chicago, Illinois, United States, 60637
United States, Indiana
Deaconess Clinic Downtown
Evansville, Indiana, United States, 47713
The Community Hospital
Munster, Indiana, United States, 46321
United States, Kentucky
Kentucky Cancer Center
Hazard, Kentucky, United States, 41701
Baptist Health System, Inc.
Lexington, Kentucky, United States, 40503
United States, Louisiana
Christus Saint Frances, Cabrini Hospital, Cabrini Cancer Center
Alexandria, Louisiana, United States, 71301
Hematology and Oncology Specialists, LLC
Metairie, Louisiana, United States, 70006
United States, Maryland
National Cancer Institute
Bethesda, Maryland, United States, 20892
Maryland Oncology Hematology, P.A.
Columbia, Maryland, United States, 21044
United States, Massachusetts
Berkshire Hematology Oncology, PC
Pittsfield, Massachusetts, United States, 01201
United States, Michigan
Detroit Clinical Research Center
Farmington Hills, Michigan, United States, 48336
United States, New Jersey
Englewood Hospital and Medical Center
Englewood, New Jersey, United States, 07631
United States, New York
Queens Hospital Center
Jamaica, New York, United States, 11432
Syracuse Veterns Affairs Medical Center
Syracuse, New York, United States, 13210
United States, Oregon
Willamette Valley Cancer Institute and Research Center
Eugene, Oregon, United States, 97401
United States, Pennsylvania
St. Luke's Cancer Center Associates
Bethlehem, Pennsylvania, United States, 18015
Gettysburg Cancer Center
Gettysburg, Pennsylvania, United States, 17325
United States, Tennessee
Tennessee Oncology, PLLC
Nashville, Tennessee, United States, 37203
United States, Texas
Texas Oncology - Bedford
Bedford, Texas, United States, 76022
University of Texas Medical Branch
Galveston, Texas, United States, 77555
Houston Cancer Institute
Houston, Texas, United States, 77055
Texas Oncology - Plano East
Plano, Texas, United States, 75075-7787
Northwest Cancer Center
Sugar Land, Texas, United States, 77479
Texas Oncology - Tyler
Tyler, Texas, United States, 75702-8363
Texas Oncology - Waco
Waco, Texas, United States, 76712
United States, Virginia
Virginia Cancer Specialists, PC
Fairfax, Virginia, United States, 22031
Delta Hematology Oncology Associates, PC
Portsmouth, Virginia, United States, 23704
United States, Washington
Virginia Mason Medical Center
Seattle, Washington, United States, 98101
Rockwood Cancer Treatment Center
Spokane, Washington, United States, 99204
Medical Oncology Associates, PS
Spokane, Washington, United States, 99208
United States, Wisconsin
Cancer Team Bellin Health
Green Bay, Wisconsin, United States, 54313
Australia, New South Wales
The Tweed Hospital
Tweed Heads, New South Wales, Australia, 2485
Southern Medical Day Oncology Care Centre
Wollongong, New South Wales, Australia, 2500
Australia, Queensland
Royal Brisbane and Women's Hospital, Dept. of Medical Oncology
Brisbane, Queensland, Australia, 4029
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia, 4102
Australia, South Australia
Royal Adelaide Hospital, Cancer Centre
Adelaide, South Australia, Australia, 5000
Flinders Medical Centre, Dept. of Oncology
Bedford Park, South Australia, Australia, 5042
Lyell McEwin Hospital
Elizabeth Vale, South Australia, Australia, 5112
The Queen Elizabeth Hospital
Woodville South, South Australia, Australia, 5011
Australia, Victoria
Box Hill Hospital
Box Hill, Victoria, Australia, 3128
Frankston Hospital, Oncology Day Unit
Frankston, Victoria, Australia, 3199
Epworth Healthcare
Richmond, Victoria, Australia, 3002
Australia, Western Australia
Fremantle Hospital
Fremantle, Western Australia, Australia, 6160
Canada, Ontario
Royal Victoria Hospital
Barrie, Ontario, Canada, L4M 6M2
Grand River Regional Cancer Centre
Kitchener, Ontario, Canada, N2G 1G3
Princess Margaret Hospital
Toronto, Ontario, Canada, MSG 2L7
Canada, Quebec
Jewish General Hospital
Montréal, Quebec, Canada, H3T 1E2
Germany
Universitätsklinikum Heidelberg
Heidelberg, Baden-wuerttemberg, Germany, 69126
Klinik Löwenstein gGmbH
Löwenstein, Baden-wuerttemberg, Germany, 74245
Asklepios Fachkliniken München-Gauting
Gauting, Bayern, Germany, 82131
Krankenhaus Nordwest GmbH
Frankfurt am Main, Hessen, Germany, 60488
Johannes-Wesling-Klinikum Minden
Minden, Nordrhein-westfalen, Germany, 32429
Städtisches Krankenhaus Martha-Maria Halle Dölau gGmbH
Halle, Sachsen-anhalt, Germany, 06120
HELIOS Klinikum Emil von Behring
Berlin, Germany, 14165
Asklepios Klinik Harburg
Hamburg, Germany, 21075
Italy
Ospedale Unico Versilia
Lido di Camaiore, Lucca, Italy, 55043
Azienda Ospedaliero-Univesitaria "San Luigi Gonzaga"
Orbassano, Torino, Italy, 10043
Istituto Nazionale per la Ricerca sul Cancro
Genova, Italy, 16132
A.O. Seconda Università degli Studi di Napoli
Napoli, Italy, 80131
Poland
Wojewódzki Szpital Zespolony im. L. Rydygiera w Toruniu Szpital Dzieciecy
Torun, Kujawsko-pomorskie, Poland, 87-100
Centrum Onkologii - Instytut im. M. Sklodowskiej-Curie w Warszawie
Warszawa, Mazowieckie, Poland, 02-781
Specjalistyczny Szpital im. Alfreda Sokolowskiego
Szczecin, Zachodniopomorskie, Poland, 70-891
Russian Federation
Republican Clinical Oncologic Dispensary of Ministry of health of Republic Tatarstan
Kazan, Tatarstan, Russian Federation, 420029
Cancer Research Center n.a. N.N. Blokhin
Moscow, Russian Federation, 115478
City Oncology Hospital # 62
Moscow, Russian Federation, 143423
Spain
Hospital Regional Carlos Haya
Málaga, Malaga, Spain, 29010
Hospital General Vall d'Hebron, Barcelona
Barcelona, Spain, 08035
Hospital Clinic i Provincial de Barcelona
Barcelona, Spain, 08036
Hospital Germans Trías i Pujol
Barcelona, Spain, 08916
Fundación Jiménez Díaz
Madrid, Spain, 28040
Sponsors and Collaborators
Morphotek
  More Information

Responsible Party: Morphotek
ClinicalTrials.gov Identifier: NCT01218516     History of Changes
Other Study ID Numbers: MORAb-003-009
First Submitted: October 7, 2010
First Posted: October 11, 2010
Last Update Posted: June 20, 2016
Last Verified: June 2016

Additional relevant MeSH terms:
Adenocarcinoma
Lung Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Paclitaxel
Albumin-Bound Paclitaxel
Cisplatin
Carboplatin
Pemetrexed
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors