Efficacy Study of MORAb-009 in Subjects With Pleural Mesothelioma

August 19, 2008

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 ]

Criteria

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

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.

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DIAGNOSIS

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