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

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

ChemIDplus related topics:

Cisplatin Pemetrexed disodium Pemetrexed

U.S. FDA Resources

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:	September 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

Sponsors and Collaborators

Morphotek

More Information

Responsible Party:	Morphotek ( Martin Phillips, MD )
Study ID Numbers:	MORAb-009-003
First Received:	August 19, 2008
Last Updated:	August 19, 2008
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 October 15, 2008

Sponsored by:	Morphotek
Information provided by:	Morphotek
ClinicalTrials.gov Identifier:	NCT00738582