An Efficacy Study of MORAb-009 (Amatuximab) in Subjects With Pleural Mesothelioma
- Conditions
- Malignant Pleural Mesothelioma
- Interventions
- Registration Number
- NCT00738582
- Lead Sponsor
- Morphotek
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 89
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Open Label MORAb-009 (Amatuximab) Pemetrexed, Cisplatin and MORAb-009 (Amatuximab) Open Label Pemetrexed Pemetrexed, Cisplatin and MORAb-009 (Amatuximab) Open Label Cisplatin Pemetrexed, Cisplatin and MORAb-009 (Amatuximab)
- Primary Outcome Measures
Name Time Method Number of Participants With Progression Free Survival (PFS) Responders and Non-responders at Month 6 Month 6 Number of participants with PFS responders and non-responders at Month 6 was reported. PFS was defined as the time from the date of the first dose of amatuximab to the date of disease progression or death due to any cause, as determined by independent radiologist based on the modified Response Evaluation Criteria in Solid Tumors (RECIST) utilizing the total tumor measurement (performed by computerized tomography (CT)/magnetic resonance imaging (MRI)) which includes the pleural unidimensional measure plus the total of the target lesion(s) measurement. A "response", in terms of PFS, was defined to be at least a 6-month stabilization of disease. Progressive disease (PD) as measured by Modified RECIST was defined as an increase of at least 20 percent (%) in the total tumor measurement over the nadir measurement, or the appearance of one or more new lesions.
- Secondary Outcome Measures
Name Time Method Time to Tumor Response (TTR) From the date of the first dose to first documentation of objective response, up to approximately 5 years TTR was derived for those participants with objective evidence of CR or PR. TTR was defined as the time from the date of the first dose of amatuximab to first documentation of objective tumor response. CR was defined as the disappearance of all target lesions with no evidence of tumor elsewhere, and PR was defined as at least a 30% reduction in the total tumor measurement.
Overall Survival (OS) From the date of first dose to the date of death, up to approximately 5 years OS was defined as the time from the date of the first dose of amatuximab to the date of death.
Overall Response Rate (ORR) From the date of first dose until evidence of CR or PR, up to approximately 5 years ORR, defined as the percentage of participants with objective evidence of complete response (CR) or partial response (PR) as determined by independent radiologist based on the modified RECIST utilizing the total tumor measurement (performed by CT/ MRI) which includes the pleural unidimensional measure plus the total of the target lesion(s) measurement. Tumor assessments performed up to the initiation of further anticancer therapy were considered. CR was defined as the disappearance of all target lesions with no evidence of tumor elsewhere, and PR was defined as at least a 30% reduction in the total tumor measurement. A confirmed response required a repeat observation on two occasions 4 weeks apart. ORR = CR + PR.
Duration of Response (DR) From the first documentation of objective response (CR or PR) to the first documentation of disease progression, up to approximately 5 years DR was derived for those participants who achieved a PFS Response and had an objective evidence of CR or PR. DR was defined as the time (in months) from first documentation of objective response (CR or PR) to the first documentation of disease progression or death \[as determined by independent radiologist based on the modified RECIST utilizing the total tumor measurement (performed by CT/ MRI) which includes the pleural unidimensional measure plus the total of the target lesion(s) measurement\]. Tumor assessments performed up to the initiation of further anticancer therapy were considered. CR was defined as the disappearance of all target lesions with no evidence of tumor elsewhere, and PR was defined as at least a 30% reduction in the total tumor measurement. PD as measured by Modified RECIST was defined as an increase of at least 20% in the total tumor measurement over the nadir measurement, or the appearance of one or more new lesions.
Overall Progression Free Survival From the date of first dose of amatuximab to the date of disease progression, up to approximately 5 years Overall PFS was defined as the time from the date of first dose of amatuximab to the date of disease progression or death due to any cause. In the absence of confirmation of death, the survival time was censored at the date of the last follow-up contact. Tumor assessments performed up to the initiation of further anticancer therapy were considered. PD as measured by Modified RECIST was defined as an increase of at least 20% in the total tumor measurement over the nadir measurement, or the appearance of one or more new lesions.
Trial Locations
- Locations (28)
Mary Babb Randolph Cancer Center
🇺🇸Morgantown, West Virginia, United States
University of California, San Francisco
🇺🇸San Francisco, California, United States
Asklepios Fachkliniken Müchen-Gauting
🇩🇪Gauting, Germany
Asklepios Klinik Harburg
🇩🇪Hamburg, Germany
University of Chicago Medical Center
🇺🇸Chicago, Illinois, United States
Medizinsche Hochschule Hannover
🇩🇪Hannover, Germany
Erasmus MC
🇳🇱Rotterdam, Netherlands
Emory University School of Medicine
🇺🇸Atlanta, Georgia, United States
Hopital Laval
🇨🇦Quebec, PQ, Canada
H. de la Santa Creu i Sant Pau
🇪🇸Barcelona, Spain
Consorci Sanitari Parc TaulÃ
🇪🇸Barcelona, Spain
H. Virgen del RocÃo
🇪🇸Sevilla, Spain
University of California, San Diego
🇺🇸La Jolla, California, United States
Princess Margaret Hospital
🇨🇦Toronto, Ontario, Canada
Krankenhaus Großhansdorf
🇩🇪Großhansdorf, Germany
Medizinische Klinik (Hämatologie/Onkologie)
🇩🇪München, Germany
ClÃnica Universitaria de Navarra
🇪🇸Pamplona, Spain
H. Son Dureta
🇪🇸Palma de Mallorca, Spain
HELIOS Klinikum Emil von Behring
🇩🇪Berlin, Germany
University of Alabama, Birmingham
🇺🇸Birmingham, Alabama, United States
NIH/National Cancer Institute
🇺🇸Bethesda, Maryland, United States
University of Colorado Cancer Center
🇺🇸Aurora, Colorado, United States
Christiana Care Health System
🇺🇸Newark, Delaware, United States
Johns Hopkins University--Sidney Kimmel Comprehensive Cancer Center
🇺🇸Baltimore, Maryland, United States
Columbia University Medical Center
🇺🇸New York, New York, United States
Medisch Spectrum Twente
🇳🇱Enschede, Netherlands
Fachklinik für Lungenerkrankungen Immenhausen
🇩🇪Immenhausen, Germany
UCLA Medical Hematology & Oncology
🇺🇸Los Angeles, California, United States