Articles and Resources


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

This study is currently recruiting participants.
Verified by Morphotek, January 2009
Sponsored by: Morphotek
Information provided by: Morphotek
ClinicalTrials.gov Identifier: NCT00738582
  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 given on days 1 and 8 of each
21 day treatment cycle.
Phase II

MedlinePlus related topics: Mesothelioma
Study Type: Interventional
Study Design: Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title: An Open-Label Clinical Trial of MORAb-009 in Combination With Pemetrexed and Cisplatin in Subjects With Mesothelioma

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, and overall survival. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 86
Study Start Date: December 2008
Estimated Study Completion Date: March 2012
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Open Label: Experimental
Pemetrexed, Cisplatin and MORAb-009
Drug: MORAb-009 given on days 1 and 8 of each 21 day treatment cycle.
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

Inclusion Criteria:

  • Histological confirmed unresectable malignant pleural mesothelioma(MPM)(epithelial or mixed subtypes of at least 75% epithelial 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

Exclusion Criteria:

  • Sarcomatous subtype of malignant pleural mesothelioma
  • Prior systemic therapy or radiotherapy of MPM; local radiotherapy for symptom control (ie, non-curative intent) is permitted.
  • Confirmed presence of CNS metastases.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00738582

Contacts
Contact: Susan Weil, MD 610-423-6182    

Locations
United States, Delaware
Christiana Care Health System Recruiting
Newark, Delaware, United States, 19713
Contact: Kathy Combs, RN, OCN     302-733-6269     kcombs@christianacare.org    
Principal Investigator: Michael Guarino, MD            
United States, New York
NYU Medical Center Recruiting
New York, New York, United States, 10016
Contact: Audrey Sorensen, RN     212-263-2562     audrey.sorensen@med.nyu.edu    
Principal Investigator: Harvey Pass, MD            
Sponsors and Collaborators
Morphotek
  More Information

Responsible Party: Morphotek ( Martin Phillips, MD )
Study ID Numbers: MORAb-009-003
Study First Received: August 19, 2008
Last Updated: January 19, 2009
ClinicalTrials.gov Identifier: NCT00738582  
Health Authority: United States: Food and Drug Administration

Study placed in the following topic categories:
Pemetrexed
Cisplatin
Mesothelioma
Adenoma
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Mesothelial

ClinicalTrials.gov processed this record on January 22, 2009

Source: www.ClinicalTrials.gov