An Efficacy Study of MORAb-009 (Amatuximab) in Subjects With Pleural Mesothelioma

Malignant Pleural Mesothelioma Clinical Trial

— Amatuximab  

Official title:

An Open-Label Clinical Trial of MORAb-009 in Combination With Pemetrexed and Cisplatin in Subjects With Mesothelioma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00738582
• Other study ID #: MORAb-009-003 Amatuximab
• Secondary ID: 2008-005448-18
• Status: Completed
• Phase: Phase 2
• Start date: December 31, 2008
• Est. completion date: January 10, 2014

Study information

• Verified date: November 2015
• Source: Morphotek
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Other known NCT identifiers

• NCT00923455

Recruitment information / eligibility

• Status: Completed
• Enrollment: 89
• Est. completion date: January 10, 2014
• Est. primary completion date: June 30, 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Malignant Pleural Mesothelioma
• Mesothelioma
• Mesothelioma, Malignant

Intervention

Drug:
• 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

Locations

Country	Name	City	State
Canada	Hopital Laval	Quebec, PQ
Canada	Princess Margaret Hospital	Toronto	Ontario
Germany	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	Hannover
Germany	Fachklinik für Lungenerkrankungen Immenhausen	Immenhausen
Germany	Medizinische Klinik (Hämatologie/Onkologie)	München
Netherlands	Medisch Spectrum Twente	Enschede
Netherlands	Erasmus MC	Rotterdam
Spain	Consorci Sanitari Parc Taulí	Barcelona
Spain	H. de la Santa Creu i Sant Pau	Barcelona
Spain	H. Son Dureta	Palma de Mallorca
Spain	Clínica Universitaria de Navarra	Pamplona
Spain	H. Virgen del Rocío	Sevilla
United States	Emory University School of Medicine	Atlanta	Georgia
United States	University of Colorado Cancer Center	Aurora	Colorado
United States	Johns Hopkins University--Sidney Kimmel Comprehensive Cancer Center	Baltimore	Maryland
United States	NIH/National Cancer Institute	Bethesda	Maryland
United States	University of Alabama, Birmingham	Birmingham	Alabama
United States	University of Chicago Medical Center	Chicago	Illinois
United States	University of California, San Diego	La Jolla	California
United States	UCLA Medical Hematology & Oncology	Los Angeles	California
United States	Mary Babb Randolph Cancer Center	Morgantown	West Virginia
United States	Columbia University Medical Center	New York	New York
United States	Christiana Care Health System	Newark	Delaware
United States	University of California, San Francisco	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
Morphotek

Countries where clinical trial is conducted

United States,  Canada,  Germany,  Netherlands,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) as a Measure of Safety and Tolerability of Amatuximab	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.	From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
Primary	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.	Month 6
Secondary	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.	From the date of first dose until evidence of CR or PR, up to approximately 5 years
Secondary	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.	From the first documentation of objective response (CR or PR) to the first documentation of disease progression, up to approximately 5 years
Secondary	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.	From the date of the first dose to first documentation of objective response, up to approximately 5 years
Secondary	Overall Survival (OS)	OS was defined as the time from the date of the first dose of amatuximab to the date of death.	From the date of first dose to the date of death, up to approximately 5 years
Secondary	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.	From the date of first dose of amatuximab to the date of disease progression, up to approximately 5 years