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An Efficacy Study of MORAb-009 in Subjects With Pleural Mesothelioma
This study is currently recruiting participants.
Verified by Morphotek, January 2009
| Sponsored by: |
Morphotek |
|---|---|
| Information provided by: | Morphotek |
| ClinicalTrials.gov Identifier: | NCT00738582 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Malignant Pleural Mesothelioma |
Drug: MORAb-009 given on days 1 and 8 of each 21 day treatment cycle. |
Phase II |
MedlinePlus related topics:
Mesothelioma
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | An Open-Label Clinical Trial of MORAb-009 in Combination With Pemetrexed and Cisplatin in Subjects With Mesothelioma |
Further study details as provided by Morphotek:
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, and overall survival. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 86 |
| Study Start Date: | December 2008 |
| Estimated Study Completion Date: | March 2012 |
| Estimated Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Open Label: Experimental
Pemetrexed, Cisplatin and MORAb-009
|
Drug: MORAb-009 given on days 1 and 8 of each 21 day treatment cycle.
Pemetrexed and Cisplatin per package insert.
|
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Histological confirmed unresectable malignant pleural mesothelioma(MPM)(epithelial or mixed subtypes of at least 75% epithelial 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 subtype of malignant pleural mesothelioma
- Prior systemic therapy or radiotherapy of MPM; local radiotherapy for symptom control (ie, non-curative intent) is permitted.
- Confirmed presence of CNS metastases.
Contacts and
Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00738582
Contacts
| Contact: Susan Weil, MD | 610-423-6182 |
Locations
| United States, Delaware | |
| Christiana Care Health System | Recruiting |
| Newark, Delaware, United States, 19713 | |
| Contact: Kathy Combs, RN, OCN 302-733-6269 kcombs@christianacare.org | |
| Principal Investigator: Michael Guarino, MD | |
| United States, New York | |
| NYU Medical Center | Recruiting |
| New York, New York, United States, 10016 | |
| Contact: Audrey Sorensen, RN 212-263-2562 audrey.sorensen@med.nyu.edu | |
| Principal Investigator: Harvey Pass, MD | |
Sponsors and Collaborators
Morphotek
More Information
Study placed in the following topic categories:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on January 22, 2009
| Responsible Party: | Morphotek ( Martin Phillips, MD ) |
| Study ID Numbers: | MORAb-009-003 |
| Study First Received: | August 19, 2008 |
| Last Updated: | January 19, 2009 |
| ClinicalTrials.gov Identifier: | NCT00738582 |
| Health Authority: | United States: Food and Drug Administration |
Study placed in the following topic categories:
|
Pemetrexed Cisplatin Mesothelioma Adenoma Neoplasms, Glandular and Epithelial |
Additional relevant MeSH terms:
|
Neoplasms Neoplasms by Histologic Type Neoplasms, Mesothelial |
ClinicalTrials.gov processed this record on January 22, 2009
Source: www.ClinicalTrials.gov