An Efficacy Study of MORAb-009 (Amatuximab) in Subjects With Pleural Mesothelioma (Amatuximab)
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ClinicalTrials.gov Identifier: NCT00738582 |
Recruitment Status :
Completed
First Posted : August 20, 2008
Last Update Posted : December 11, 2015
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Condition or disease | Intervention/treatment | Phase |
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Malignant Pleural Mesothelioma | Drug: MORAb-009 (Amatuximab) Drug: Pemetrexed Drug: Cisplatin | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 89 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (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 |
Study Start Date : | December 2008 |
Actual Primary Completion Date : | June 2011 |
Actual Study Completion Date : | January 2014 |

Arm | Intervention/treatment |
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Experimental: Open Label
Pemetrexed, Cisplatin and MORAb-009 (Amatuximab)
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Drug: MORAb-009 (Amatuximab)
MORAb-009 (Amatuximab) by IV on Days 1 and 8 every 21 days for 6 cycles. Drug: Pemetrexed Pemetrexed 500 mg/m2 on Day 1 of each 21-day cycle for 6 cycles Drug: Cisplatin Cisplatin 75 mg/m2 on Day 1 of each 21-day cycle for 6 cycles |
- Progression free survival using the EORTC modified RECIST criteria. [ Time Frame: 1 year ]
- Overall response, duration of survival, overall survival and safety. [ Time Frame: 1 year ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00738582

Study Director: | Bruce Wallin, MD | Morphotek |
Responsible Party: | Morphotek |
ClinicalTrials.gov Identifier: | NCT00738582 |
Obsolete Identifiers: | NCT00923455 |
Other Study ID Numbers: |
MORAb-009-003 Amatuximab |
First Posted: | August 20, 2008 Key Record Dates |
Last Update Posted: | December 11, 2015 |
Last Verified: | November 2015 |
Mesothelioma Adenoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasms, Mesothelial Cisplatin |
Pemetrexed Antineoplastic Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Folic Acid Antagonists Nucleic Acid Synthesis Inhibitors |