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Trial record 3 of 4 for:    mesothelioma AND West Virginia

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

This study has been completed.
Information provided by (Responsible Party):
Morphotek Identifier:
First received: August 19, 2008
Last updated: November 13, 2015
Last verified: November 2015
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 Intervention Phase
Malignant Pleural Mesothelioma Drug: MORAb-009 (Amatuximab) Drug: Pemetrexed Drug: Cisplatin Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Morphotek:

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

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

Enrollment: 89
Study Start Date: December 2008
Study Completion Date: January 2014
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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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Please refer to this study by its identifier: NCT00738582

  Show 28 Study Locations
Sponsors and Collaborators
Study Director: Bruce Wallin, MD Morphotek
  More Information

Responsible Party: Morphotek Identifier: NCT00738582     History of Changes
Obsolete Identifiers: NCT00923455
Other Study ID Numbers: MORAb-009-003 Amatuximab
Study First Received: August 19, 2008
Last Updated: November 13, 2015

Additional relevant MeSH terms:
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Mesothelial
Antibodies, Monoclonal
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors
Immunologic Factors
Physiological Effects of Drugs processed this record on August 18, 2017