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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Morphotek
ClinicalTrials.gov Identifier:
NCT00738582
First received: August 19, 2008
Last updated: January 8, 2013
Last verified: January 2013
History of Changes
  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 by IV on Days 1 and 8 every 21 days for 6 cycles.
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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:

MedlinePlus related topics: Mesothelioma
U.S. FDA Resources

Further study details as provided by Morphotek:

Primary Outcome Measures:
  • Progression free survival using the EORTC modified RECIST criteria. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall response, duration of survival, overall survival and safety. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment: 89
Study Start Date: December 2008
Estimated Study Completion Date: February 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 by IV on Days 1 and 8 every 21 days for 6 cycles.
Pemetrexed and Cisplatin per package insert.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00738582

  Show 28 Study Locations
Sponsors and Collaborators
Morphotek
  More Information

No publications provided

Responsible Party: Morphotek
ClinicalTrials.gov Identifier: NCT00738582     History of Changes
Obsolete Identifiers: NCT00923455
Other Study ID Numbers: MORAb-009-003 Amatuximab
Study First Received: August 19, 2008
Last Updated: January 8, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Mesothelioma
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Mesothelial
Pemetrexed
Cisplatin
Antineoplastic Agents
 Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Antimetabolites, Antineoplastic
Antimetabolites

ClinicalTrials.gov processed this record on June 17, 2013