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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00738582
Recruitment Status : Completed
First Posted : August 20, 2008
Last Update Posted : December 11, 2015
Sponsor:
Information provided by (Responsible Party):
Morphotek

Study Description
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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.

Condition or disease Intervention/treatment Phase
Malignant Pleural Mesothelioma Drug: MORAb-009 (Amatuximab) Drug: Pemetrexed Drug: Cisplatin Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 89 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label Clinical Trial of MORAb-009 in Combination With Pemetrexed and Cisplatin in Subjects With Mesothelioma
Study Start Date : December 2008
Actual Primary Completion Date : June 2011
Actual Study Completion Date : January 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mesothelioma

Arms and Interventions
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Arm Intervention/treatment
Experimental: Open Label
Pemetrexed, Cisplatin and MORAb-009 (Amatuximab)
 Drug: MORAb-009 (Amatuximab)
MORAb-009 (Amatuximab) by IV on Days 1 and 8 every 21 days for 6 cycles.

Drug: Pemetrexed
Pemetrexed 500 mg/m2 on Day 1 of each 21-day cycle for 6 cycles

Drug: Cisplatin
Cisplatin 75 mg/m2 on Day 1 of each 21-day cycle for 6 cycles


Outcome Measures
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Primary Outcome Measures :
  1. Progression free survival using the EORTC modified RECIST criteria. [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Overall response, duration of survival, overall survival and safety. [ Time Frame: 1 year ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00738582


Locations
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Sponsors and Collaborators
Morphotek
Investigators
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Study Director: Bruce Wallin, MD Morphotek
More Information
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Responsible Party: Morphotek
ClinicalTrials.gov Identifier: NCT00738582    
Obsolete Identifiers: NCT00923455
Other Study ID Numbers: MORAb-009-003 Amatuximab
First Posted: August 20, 2008    Key Record Dates
Last Update Posted: December 11, 2015
Last Verified: November 2015
Additional relevant MeSH terms:
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Mesothelioma
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Mesothelial
 Pemetrexed
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors