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

Morphotek

Status and phase: Completed; Phase 2

Conditions: Malignant Pleural Mesothelioma

Treatments: Drug: Cisplatin; Drug: MORAb-009 (Amatuximab); Drug: Pemetrexed

Study type: Interventional

Funder types: Industry

Identifiers

NCT00738582

2008-005448-18 (EudraCT Number)

MORAb-009-003 Amatuximab

Details and patient eligibility

About

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.

Enrollment: 89 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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89 participants in 1 patient group

Open Label

Experimental group

Description:

Pemetrexed, Cisplatin and MORAb-009 (Amatuximab)

Treatment:

Drug: Cisplatin

Drug: Pemetrexed

Drug: MORAb-009 (Amatuximab)