An Efficacy Study of MORAb-009 (Amatuximab) in Subjects With Pleural Mesothelioma
NCT ID: NCT00738582
Last Updated: 2022-09-22
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
89 participants
INTERVENTIONAL
2008-12-31
2014-01-10
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Open Label
Pemetrexed, Cisplatin and MORAb-009 (Amatuximab)
MORAb-009 (Amatuximab)
MORAb-009 (Amatuximab) by IV on Days 1 and 8 every 21 days for 6 cycles.
Pemetrexed
Pemetrexed 500 mg/m2 on Day 1 of each 21-day cycle for 6 cycles
Cisplatin
Cisplatin 75 mg/m2 on Day 1 of each 21-day cycle for 6 cycles
Interventions
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MORAb-009 (Amatuximab)
MORAb-009 (Amatuximab) by IV on Days 1 and 8 every 21 days for 6 cycles.
Pemetrexed
Pemetrexed 500 mg/m2 on Day 1 of each 21-day cycle for 6 cycles
Cisplatin
Cisplatin 75 mg/m2 on Day 1 of each 21-day cycle for 6 cycles
Eligibility Criteria
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Inclusion Criteria
* Measurable disease at Screening by computed tomography (CT)(or magnetic resonance imaging \[MRI\]).
* KPS of greater than or equal to 70% at Screening.
* Life expectancy of at least 3 months
Exclusion Criteria
* Prior systemic therapy or radiotherapy for MPM; local radiotherapy for symptom control (ie, non-curative intent) is permitted.
* Confirmed presence of CNS tumor involvement.
* Evidence of other active malignancy requiring treatment.
18 Years
ALL
No
Sponsors
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Morphotek
INDUSTRY
Responsible Party
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Principal Investigators
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Bruce Wallin, MD
Role: STUDY_DIRECTOR
Morphotek
Locations
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Princess Margaret Hospital
Toronto, Ontario, Canada
Hopital Laval
Quebec, PQ, , Canada
HELIOS Klinikum Emil von Behring
Berlin, , Germany
Asklepios Fachkliniken Müchen-Gauting
Gauting, , Germany
Krankenhaus Großhansdorf
Großhansdorf, , Germany
Asklepios Klinik Harburg
Hamburg, , Germany
Medizinsche Hochschule Hannover
Hanover, , Germany
University of Alabama, Birmingham
Birmingham, Alabama, United States
University of California, San Diego
La Jolla, California, United States
UCLA Medical Hematology & Oncology
Los Angeles, California, United States
University of California, San Francisco
San Francisco, California, United States
University of Colorado Cancer Center
Aurora, Colorado, United States
Christiana Care Health System
Newark, Delaware, United States
Emory University School of Medicine
Atlanta, Georgia, United States
University of Chicago Medical Center
Chicago, Illinois, United States
Johns Hopkins University--Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, United States
NIH/National Cancer Institute
Bethesda, Maryland, United States
Columbia University Medical Center
New York, New York, United States
Mary Babb Randolph Cancer Center
Morgantown, West Virginia, United States
Fachklinik für Lungenerkrankungen Immenhausen
Immenhausen, , Germany
Medizinische Klinik (Hämatologie/Onkologie)
München, , Germany
Medisch Spectrum Twente
Enschede, , Netherlands
Erasmus MC
Rotterdam, , Netherlands
H. de la Santa Creu i Sant Pau
Barcelona, , Spain
Consorci Sanitari Parc Taulí
Barcelona, , Spain
H. Son Dureta
Palma de Mallorca, , Spain
Clínica Universitaria de Navarra
Pamplona, , Spain
H. Virgen del Rocío
Seville, , Spain
Countries
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Other Identifiers
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2008-005448-18
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
MORAb-009-003 Amatuximab
Identifier Type: -
Identifier Source: org_study_id
NCT00923455
Identifier Type: -
Identifier Source: nct_alias
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