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

This study is ongoing, but not recruiting participants.

First Received on August 19, 2008. Last Updated on December 7, 2011 History of Changes

Sponsor:	Morphotek
Information provided by (Responsible Party):	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 Amatuximab 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

Drug Information available for: Cisplatin Pemetrexed Pemetrexed disodium

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:	February 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 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 28 Study Locations

Sponsors and Collaborators

Morphotek

More Information

No publications provided

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:	December 7, 2011
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
Pemetrexed
Cisplatin
Antineoplastic Agents

Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Antimetabolites, Antineoplastic
Antimetabolites

ClinicalTrials.gov processed this record on February 02, 2012