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

Brief Summary

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.

Tracking Information
First Received DateAugust 19, 2008
Last Changed DateNovember 13, 2015
Start DateDecember 2008
Actual Primary Completion DateJune 2011
Primary Outcome Measures

Progression free survival using the EORTC modified RECIST criteria. [Time Frame: 1 year]

Secondary Outcome Measures

Overall response, duration of survival, overall survival and safety. [Time Frame: 1 year]

Descriptive Information
PhasePhase 2
Study TypeInterventional
Condition
  • Malignant Pleural Mesothelioma
Intervention
  • Drug: MORAb-009 (Amatuximab)
  • Drug: Pemetrexed
  • Drug: Cisplatin
Study Arms / Comparison Groups1 / 0
Recruitment Information
Recruitment StatusCompleted
Actual Enrollment89
GenderAll
Ages18 Years - N/A
Accepts Healthy VolunteersNo
Eligibility 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.

Administrative Information
NCTIDNCT00738582
Responsible Party,
SponsorMorphotek
Verification DateNovember 2015
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