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An Open-Label Clinical Trial of MORAb-009 in Combination With Pemetrexed and Cisplatin in Subjects With Mesothelioma


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Malignant Pleural Mesothelioma

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Trial Information

An Open-Label Clinical Trial of MORAb-009 in Combination With Pemetrexed and Cisplatin in Subjects With Mesothelioma


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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression free survival using the EORTC modified RECIST criteria.

Outcome Time Frame:

1 year

Safety Issue:

No

Authority:

United States: Food and Drug Administration

Study ID:

MORAb-009-003 Amatuximab

NCT ID:

NCT00738582

Start Date:

December 2008

Completion Date:

February 2014

Related Keywords:

  • Malignant Pleural Mesothelioma
  • Mesothelioma

Name

Location

University of Colorado Cancer CenterDenver, Colorado  80262
Emory University School of MedicineAtlanta, Georgia  30322
University of California, San FranciscoSan Francisco, California  94143
University of Chicago Medical CenterChicago, Illinois  60637
Mary Babb Randolph Cancer CenterMorgantown, West Virginia  26506
University of California, San DiegoLa Jolla, California  92037-1709
University of Alabama, BirminghamBirmingham, Alabama  35233
Columbia University Medical CenterNew York, New York  10032
UCLA Medical Hematology & OncologyLos Angeles, California  90095
Christiana Care Health SystemNewark, Delaware  19713
Johns Hopkins University--Sidney Kimmel Comprehensive Cancer CenterBaltimore, Maryland  21201
NIH/National Cancer InstituteBethesda, Maryland  20892