Clinical trial NCT00738582: An Efficacy Study of MORAb-009 (Amatuximab) in Subjects With Pleural Mesothelioma
Official title: An Open-Label Clinical Trial of MORAb-009 in Combination With Pemetrexed and Cisplatin in Subjects With Mesothelioma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Malignant Pleural Mesothelioma
Lead sponsor: Morphotek
Sponsor class: INDUSTRY
First posted: 2008-08-20
Enrollment: 89
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This research is being done to find out if pemetrexed and cisplatin work better when given together with an experimental drug called MORAb-009 in patients with malignant pleural mesothelioma.


Eligibility criteria: Primary Inclusion Criteria:

* Confirmed diagnosis of malignant pleural mesothelioma (MPM) with the following characteristics: unresectable disease (or otherwise not a candidate for curative surgery); epithelial type or biphasic (mixed) type with low sarcomatous content.
* 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

Primary Exclusion Criteria:

* Sarcomatous type of mesothelioma
* 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.

Primary outcomes:
measure: Number of Participants With Progression Free Survival (PFS) Responders and Non-responders at Month 6
timeFrame: Month 6
Secondary outcomes:
measure: Overall Response Rate (ORR)
timeFrame: From the date of first dose until evidence of CR or PR, up to approximately 5 years
measure: Duration of Response (DR)
timeFrame: From the first documentation of objective response (CR or PR) to the first documentation of disease progression, up to approximately 5 years
measure: Time to Tumor Response (TTR)
timeFrame: From the date of the first dose to first documentation of objective response, up to approximately 5 years
measure: Overall Survival (OS)
timeFrame: From the date of first dose to the date of death, up to approximately 5 years
measure: Overall Progression Free Survival
timeFrame: From the date of first dose of amatuximab to the date of disease progression, up to approximately 5 years
Other outcomes:
measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) as a Measure of Safety and Tolerability of Amatuximab
timeFrame: From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
Locations:
city: Birmingham
country: United States
facility: University of Alabama, Birmingham
state: Alabama
city: La Jolla
country: United States
facility: University of California, San Diego
state: California
city: Los Angeles
country: United States
facility: UCLA Medical Hematology & Oncology
state: California
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
city: Aurora
country: United States
facility: University of Colorado Cancer Center
state: Colorado
city: Newark
country: United States
facility: Christiana Care Health System
state: Delaware
city: Atlanta
country: United States
facility: Emory University School of Medicine
state: Georgia
city: Chicago
country: United States
facility: University of Chicago Medical Center
state: Illinois
city: Baltimore
country: United States
facility: Johns Hopkins University--Sidney Kimmel Comprehensive Cancer Center
state: Maryland
city: Bethesda
country: United States
facility: NIH/National Cancer Institute
state: Maryland
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: Morgantown
country: United States
facility: Mary Babb Randolph Cancer Center
state: West Virginia
city: Toronto
country: Canada
facility: Princess Margaret Hospital
state: Ontario
city: Quebec, PQ
country: Canada
facility: Hopital Laval
city: Berlin
country: Germany
facility: HELIOS Klinikum Emil von Behring
city: Gauting
country: Germany
facility: Asklepios Fachkliniken Müchen-Gauting
city: Großhansdorf
country: Germany
facility: Krankenhaus Großhansdorf
city: Hamburg
country: Germany
facility: Asklepios Klinik Harburg
city: Hannover
country: Germany
facility: Medizinsche Hochschule Hannover
city: Immenhausen
country: Germany
facility: Fachklinik für Lungenerkrankungen Immenhausen
city: München
country: Germany
facility: Medizinische Klinik (Hämatologie/Onkologie)
city: Enschede
country: Netherlands
facility: Medisch Spectrum Twente
city: Rotterdam
country: Netherlands
facility: Erasmus MC
city: Barcelona
country: Spain
facility: H. de la Santa Creu i Sant Pau
city: Barcelona
country: Spain
facility: Consorci Sanitari Parc Taulí
city: Palma de Mallorca
country: Spain
facility: H. Son Dureta
city: Pamplona
country: Spain
facility: Clínica Universitaria de Navarra
city: Sevilla
country: Spain
facility: H. Virgen del Rocío
Study officials:
affiliation: Morphotek
name: Bruce Wallin, MD
role: STUDY_DIRECTOR
References: