Back to resultsAn Efficacy Study of MORAb-009 (Amatuximab) in Subjects With Pleural Mesothelioma (Amatuximab)
Primary Purpose
Malignant Pleural Mesothelioma
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
MORAb-009 (Amatuximab)
Pemetrexed
Cisplatin
Sponsored by
About this trial
This is an interventional treatment trial for 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.
Sites / Locations
- University of Alabama, Birmingham
- University of California, San Diego
- UCLA Medical Hematology & Oncology
- University of California, San Francisco
- University of Colorado Cancer Center
- Christiana Care Health System
- Emory University School of Medicine
- University of Chicago Medical Center
- Johns Hopkins University--Sidney Kimmel Comprehensive Cancer Center
- NIH/National Cancer Institute
- Columbia University Medical Center
- Mary Babb Randolph Cancer Center
- Princess Margaret Hospital
- Hopital Laval
- HELIOS Klinikum Emil von Behring
- Asklepios Fachkliniken Müchen-Gauting
- Krankenhaus Großhansdorf
- Asklepios Klinik Harburg
- Medizinsche Hochschule Hannover
- Fachklinik für Lungenerkrankungen Immenhausen
- Medizinische Klinik (Hämatologie/Onkologie)
- Medisch Spectrum Twente
- Erasmus MC
- H. de la Santa Creu i Sant Pau
- Consorci Sanitari Parc Taulí
- H. Son Dureta
- Clínica Universitaria de Navarra
- H. Virgen del Rocío
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Open Label
Arm Description
Pemetrexed, Cisplatin and MORAb-009 (Amatuximab)
Outcomes
Primary Outcome Measures
Number of Participants With Progression Free Survival (PFS) Responders and Non-responders at 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
Overall Response Rate (ORR)
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)
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.
Time to Tumor Response (TTR)
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)
OS was defined as the time from the date of the first dose of amatuximab to the date of death.
Overall Progression Free Survival
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00738582
Brief Title
An Efficacy Study of MORAb-009 (Amatuximab) in Subjects With Pleural Mesothelioma
Acronym
Amatuximab
Official Title
An Open-Label Clinical Trial of MORAb-009 in Combination With Pemetrexed and Cisplatin in Subjects With Mesothelioma
Study Type
Interventional
2. Study Status
Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
December 31, 2008 (Actual)
Primary Completion Date
June 30, 2011 (Actual)
Study Completion Date
January 10, 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Morphotek
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malignant Pleural Mesothelioma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
89 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Open Label
Arm Type
Experimental
Arm Description
Pemetrexed, Cisplatin and MORAb-009 (Amatuximab)
Intervention Type
Drug
Intervention Name(s)
MORAb-009 (Amatuximab)
Intervention Description
MORAb-009 (Amatuximab) by IV on Days 1 and 8 every 21 days for 6 cycles.
Intervention Type
Drug
Intervention Name(s)
Pemetrexed
Intervention Description
Pemetrexed 500 mg/m2 on Day 1 of each 21-day cycle for 6 cycles
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Intervention Description
Cisplatin 75 mg/m2 on Day 1 of each 21-day cycle for 6 cycles
Primary Outcome Measure Information:
Title
Number of Participants With Progression Free Survival (PFS) Responders and Non-responders at Month 6
Description
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.
Time Frame
Month 6
Secondary Outcome Measure Information:
Title
Overall Response Rate (ORR)
Description
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.
Time Frame
From the date of first dose until evidence of CR or PR, up to approximately 5 years
Title
Duration of Response (DR)
Description
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.
Time Frame
From the first documentation of objective response (CR or PR) to the first documentation of disease progression, up to approximately 5 years
Title
Time to Tumor Response (TTR)
Description
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.
Time Frame
From the date of the first dose to first documentation of objective response, up to approximately 5 years
Title
Overall Survival (OS)
Description
OS was defined as the time from the date of the first dose of amatuximab to the date of death.
Time Frame
From the date of first dose to the date of death, up to approximately 5 years
Title
Overall Progression Free Survival
Description
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.
Time Frame
From the date of first dose of amatuximab to the date of disease progression, up to approximately 5 years
Other Pre-specified Outcome Measures:
Title
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) as a Measure of Safety and Tolerability of Amatuximab
Description
An adverse event (AE) was any untoward medical occurrence (example; any unfavorable and unintended sign including abnormal laboratory findings, symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study until the end of study visit. TEAEs were defined as an AE that developed or worsened in severity during the on-treatment period (from first dose of amatuximab to 30 days after last dose of amatuximab). SAE was defined as any adverse event (appearance of [or worsening of any pre-existing]) undesirable sign, symptom or medical conditions which is fatal or life-threatening or results in persistent or significant disability/incapacity or constitutes a congenital anomaly/birth defect or requires inpatient hospitalization or prolongation of existing hospitalization or is medically significant.
Time Frame
From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bruce Wallin, MD
Organizational Affiliation
Morphotek
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama, Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
University of California, San Diego
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
UCLA Medical Hematology & Oncology
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
University of Colorado Cancer Center
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Christiana Care Health System
City
Newark
State/Province
Delaware
ZIP/Postal Code
19713
Country
United States
Facility Name
Emory University School of Medicine
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
University of Chicago Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Johns Hopkins University--Sidney Kimmel Comprehensive Cancer Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
NIH/National Cancer Institute
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Mary Babb Randolph Cancer Center
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506
Country
United States
Facility Name
Princess Margaret Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Facility Name
Hopital Laval
City
Quebec, PQ
ZIP/Postal Code
G1V 3E6
Country
Canada
Facility Name
HELIOS Klinikum Emil von Behring
City
Berlin
ZIP/Postal Code
14165
Country
Germany
Facility Name
Asklepios Fachkliniken Müchen-Gauting
City
Gauting
ZIP/Postal Code
82131
Country
Germany
Facility Name
Krankenhaus Großhansdorf
City
Großhansdorf
ZIP/Postal Code
22927
Country
Germany
Facility Name
Asklepios Klinik Harburg
City
Hamburg
ZIP/Postal Code
21075
Country
Germany
Facility Name
Medizinsche Hochschule Hannover
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
Fachklinik für Lungenerkrankungen Immenhausen
City
Immenhausen
ZIP/Postal Code
34376
Country
Germany
Facility Name
Medizinische Klinik (Hämatologie/Onkologie)
City
München
ZIP/Postal Code
81657
Country
Germany
Facility Name
Medisch Spectrum Twente
City
Enschede
ZIP/Postal Code
7513 ER
Country
Netherlands
Facility Name
Erasmus MC
City
Rotterdam
ZIP/Postal Code
3015 CE
Country
Netherlands
Facility Name
H. de la Santa Creu i Sant Pau
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
Facility Name
Consorci Sanitari Parc Taulí
City
Barcelona
ZIP/Postal Code
08208
Country
Spain
Facility Name
H. Son Dureta
City
Palma de Mallorca
ZIP/Postal Code
07014
Country
Spain
Facility Name
Clínica Universitaria de Navarra
City
Pamplona
ZIP/Postal Code
31008
Country
Spain
Facility Name
H. Virgen del Rocío
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
12. IPD Sharing Statement
Learn more about this trial
An Efficacy Study of MORAb-009 (Amatuximab) in Subjects With Pleural Mesothelioma
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