A Study of MM-121 Combination Therapy in Patients With Advanced Non-Small Cell Lung Cancer
NCT ID: NCT00994123
Last Updated: 2016-08-22
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
162 participants
INTERVENTIONAL
2010-02-28
2015-06-30
Brief Summary
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Detailed Description
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Phase 2: Patients with Non-Small Cell Lung Cancer (NSCLC) may be enrolled to estimate the progression-free survival of the MM-121 + standard therapy.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Phase 1: Dose-Escalation
Escalating doses of MM-121 (QOW IV) and erlotinib (daily PO)
MM-121
MM-121 (SAR256212) = intravenous solution
Erlotinib
erlotinib = daily oral tablet
Phase 2: Control
Erlotinib (daily)
Erlotinib
erlotinib = daily oral tablet
Phase 2: Treatment
MM-121 (QOW IV) and erlotinib (daily PO)
MM-121
MM-121 (SAR256212) = intravenous solution
Erlotinib
erlotinib = daily oral tablet
Interventions
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MM-121
MM-121 (SAR256212) = intravenous solution
Erlotinib
erlotinib = daily oral tablet
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients must be \>/= 18 years of age.
* Patients must have adequate Performance Status (PS) as measured by ECOG and adequate end organ function.
Exclusion Criteria
* Patients who are pregnant or nursing.
* Patients with clinically significant heart failure.
* Patients with clinically significant eye or gastrointestinal abnormalities.
18 Years
ALL
No
Sponsors
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Merrimack Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Victor Moyo, MD
Role: STUDY_DIRECTOR
Merrimack Pharmaceuticals
Locations
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Birmingham, Alabama, United States
Tucson, Arizona, United States
Loma Linda, California, United States
Sacramento, California, United States
San Francisco, California, United States
Aurora, Colorado, United States
Tampa, Florida, United States
Atlanta, Georgia, United States
Lafayette, Indiana, United States
Boston, Massachusetts, United States
St Louis, Missouri, United States
Buffalo, New York, United States
New York, New York, United States
Cincinnati, Ohio, United States
Portland, Oregon, United States
Pittsburgh, Pennsylvania, United States
Charleston, South Carolina, United States
Nashville, Tennessee, United States
Dallas, Texas, United States
Edmonton, Alberta, Canada
Toronto, Ontario, Canada
Montreal, Quebec, Canada
Heidelberg, Mannheim, Germany
Bad Berka, , Germany
Frankfurt, , Germany
Heidelberg, , Germany
Lungenklinik, , Germany
Ulm, , Germany
Seoul, Gangnam-gu, South Korea
Seoul, Seodaemun-gu, South Korea
Barcelona, , Spain
Madrid, , Spain
Málaga, , Spain
Guishan, Taoyuan County, Taiwan
Taichung, , Taiwan
Taichung, , Taiwan
Tainan City, , Taiwan
Taipei, , Taiwan
Countries
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Other Identifiers
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MM-121-01-101
Identifier Type: -
Identifier Source: org_study_id
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