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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.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00738582
First Posted: August 20, 2008
Last Update Posted: December 11, 2015
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.
Information provided by (Responsible Party):
Morphotek
  Purpose
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
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


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

Responsible Party: Morphotek
ClinicalTrials.gov Identifier: NCT00738582     History of Changes
Obsolete Identifiers: NCT00923455
Other Study ID Numbers: MORAb-009-003 Amatuximab
First Submitted: August 19, 2008
First Posted: August 20, 2008
Last Update Posted: December 11, 2015
Last Verified: November 2015

Additional relevant MeSH terms:
Mesothelioma
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Mesothelial
Cisplatin
Pemetrexed
Antibodies, Monoclonal
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors
Immunologic Factors
Physiological Effects of Drugs