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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Morphotek
ClinicalTrials.gov Identifier:
NCT00738582
First received: August 19, 2008
Last updated: November 13, 2015
Last verified: November 2015
  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: 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:


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
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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 
Study First Received: August 19, 2008
Last Updated: November 13, 2015
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
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

ClinicalTrials.gov processed this record on July 24, 2016