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

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 by IV on Days 1 and 8 every 21 days for 6 cycles.	Phase II

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

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, 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 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

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, Alabama
University of Alabama, Birmingham	Recruiting
Birmingham, Alabama, United States, 35294
Contact: Anna Messer, RN, OCN 205-934-5092 anna.messer@ccc.uab.edu
Contact: Wilma Dillard 205- 975-9289 wilma.dillard@ccc.uab.edu
Principal Investigator: Francisco Robert, MD
United States, California
University of California, San Diego	Recruiting
La Jolla, California, United States, 92093
Contact: Yuri Matusov 858-246-0357 yumatusov@ucsd.edu
Principal Investigator: Lyudmila Bazhenova, MD
UCLA Medical Hematology & Oncology	Recruiting
Los Angeles, California, United States, 90095
Contact: Nathalie Chorn 310-825-4493 nchorn@mednet.ucla.edu
Principal Investigator: Edward Garon, MD
University of California, San Francisco	Recruiting
San Francisco, California, United States, 94115
Contact: Greg Nalbandian 415-353-7710 nalbandiang@surgery.ucsf.edu
Principal Investigator: Thierry Jahan, MD
United States, Colorado
University of Colorado Cancer Center	Recruiting
Aurora, Colorado, United States, 80045
Contact: Mary Jackson 303-714-1650 mary.k.jackson@uchsc.edu
Principal Investigator: Ana Oton, MD
United States, Delaware
Christiana Care Health System	Recruiting
Newark, Delaware, United States, 19713
Contact: Michele Johnson, RN, AS 302-623-4849 mjohnson@christianacare.org
Principal Investigator: Michael Guarino, MD
United States, Illinois
University of Chicago Medical Center	Recruiting
Chicago, Illinois, United States, 60637
Contact: Jennifer Shouldis, BSN, RN 773-834-3137 jshouldi@medicine.bsd.uchicago.edu
Principal Investigator: Hedy Kindler, MD
United States, Maryland
NIH/National Cancer Institute	Recruiting
Bethesda, Maryland, United States, 20892
Contact: Barbara Schuler, RN, OCN 301-435-5398 schulerb@navmed.nci.nih.gov
Principal Investigator: Raffit Hassan, MD
Johns Hopkins University--Sidney Kimmel Comprehensive Cancer Center	Recruiting
Baltimore, Maryland, United States, 21201
Contact: Julie Brahmer, MD 410-502-3696 BRAHMJU@jhmi.edu
Contact: Charles P. Raines 410-502-3696 craines1@jhmi.edu
Principal Investigator: Julie Brahmer, 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
Columbia University Medical Center	Recruiting
New York, New York, United States, 10032
Contact: Lilian Batista 212-305-6837 lb2327@columbia.edu
Principal Investigator: Robert Taub, MD
United States, West Virginia
Mary Babb Randolph Cancer Center	Recruiting
Morgantown, West Virginia, United States, 26506
Contact: Susan Collins 304-293-7348 scollins@hsc.wvu.edu
Principal Investigator: John Rogers, MD
Canada
Hopital Laval	Recruiting
Quebec, PQ, Canada, G1V 3E6
Contact: Brigitte Fortin 418.656.8711 ext 2639 brigitte.fortin@crhl.ulaval.ca
Principal Investigator: Yves Lacasse, MD

Sponsors and Collaborators

Morphotek

More Information

No publications provided

Responsible Party:	Morphotek ( Martin Phillips, MD )
Study ID Numbers:	MORAb-009-003
Study First Received:	August 19, 2008
Last Updated:	August 5, 2009
ClinicalTrials.gov Identifier:	NCT00738582 History of Changes
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

Mesothelioma
Adenoma
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on September 11, 2009