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

This study is currently recruiting participants.

Verified by Morphotek, April 2010

First Received: August 19, 2008 Last Updated: April 20, 2010 History of Changes

Sponsor:	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:	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 ]

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

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 31 Study Locations

Sponsors and Collaborators

Morphotek

More Information

No publications provided

Responsible Party:	Morphotek ( Martin Phillips, MD )
ClinicalTrials.gov Identifier:	NCT00738582 History of Changes
Obsolete Identifiers:	NCT00923455
Other Study ID Numbers:	MORAb-009-003
Study First Received:	August 19, 2008
Last Updated:	April 20, 2010
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

ClinicalTrials.gov processed this record on September 02, 2010