Clinical Trial VICCTHO1042
A Phase 1-2 Trial of MM-121 in Combination with Erlotinib in Three Groups of Patients with Non-Small Cell Lung Cancer
- Protocol No. VICCTHO1042
- Open Date: 10/11/2011
- Staging: Phase I/II
- Age Group: Adults
- Scope: National
- Objective: Phase 1: To assess the safety of the MM-121+erlotinib combination To determine the recommended Phase 2 dose of the MM-121+erlotinib combination Phase 2: To estimate the Progression Free Survival (PFS) rate of the MM-121+erlotinib combination in three defined groups of patients with non-small cell lung cancer
- Disease Sites: Non Small Cell
- Therapies: Molecular Targeted Agents / Immunotherapy / Biologics
- Drugs: MM-121 (SAR256212); Tarceva (OSI-774; erlotinib)
- Participating Institutions: Vanderbilt University
- National Clinical Trial ID: NCT00994123
- Secondary Protocol No: MM-121-01-101
Patients are being asked to take part in this study because they have advanced or metastatic non-small cell lung cancer that has recurred or progressed after standard chemotherapy(s), or they have been found to have a mutation in a protein found of the surface of cells (epidermal growth factor receptor; EGFR), or their cancer has responded to prior treatment with an EGFR tyrosine kinase inhibitor (TKI), such as erlotinib, but has since stopped responding. Merrimack Pharmaceuticals, the Sponsor of this study, wants to find out more about the study drug, MM-121. This is the second study where MM-121 is used in humans. MM-121 is an investigational product and is not approved by the U.S. Food and Drug Administration (FDA) or in any country outside of the United States. In this study, MM-121 will be used in combination with a FDA approved drug called erlotinib (Tarceva). Erlotinib is approved for the treatment of non-small cell lung cancer, but not in combination with another treatment. In laboratory studies, the combination of MM-121 and erlotinib was shown to be more effective at reducing tumor size than using either drug by itself.
|Ages Eligible for Study:||18 Years and older|
|Genders Eligible for Study:||Both|
|Accepts Healthy Volunteers:||No|
• Patients with locally advanced or metastatic non-small cell lung cancer.
• Patients must be >/= 18 years of age.
• Patients must have adequate Performance Status (PS) as measured by ECOG and adequate end organ function.
• Patients with a recent history (within 5 years) of another malignancy.
• Patients who are pregnant or nursing.
• Patients with clinically significant heart failure.
• Patients with clinically significant eye or gastrointestinal abnormalities.