Patients with Non-Small Cell Lung Cancer MedDRA version: 14.0 Level: PT Classification code 10059515 Term: Non-small cell lung cancer metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Sponsors
MERRIMACK PHARMACEUTICALS
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - 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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 154 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 75
Exclusion criteria
Exclusion criteria: - 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary Phase 1 Objective : ? To assess the safety of the MM-121 + erlotinib combination ? To determine the recommended Phase 2 doses of the MM-121 + erlotinib combination Primary Phase 2 Objective: To estimate the Progression Free Survival (PFS) of the MM-121 + erlotinib combination in three distinct groups of patients with non-small cell lung cancer;Secondary Objective: Secondary Objectives: ? To describe the dose limiting toxicity of the MM- 121 + erlotinib combination ? To determine the adverse event profile of the MM- 121 + erlotinib combination ? To determine the pharmacokinetic parameters and immunogenicity of the MM-121 + erlotinib combination ? To obtain an initial estimate of other key efficacy endpoints (objective response rate, disease control rate, overall survival and overall PFS) in this population for use in planning subsequent randomized phase 2/3 trials ? To gather exploratory clinical data on a potentially predictive set of biomarkers to be measured in serum and tumor tissue;Primary end point(s): Phase I: To determine the recommended Phase 2 dose of the MM-121 + erlotinib combination based upon either the maximum tolerated dose (MTD) or the maximum feasible dose of the combination in patients with NSCLC. Phase II: To estimate the progression-free survival of the MM-121 + erlotinib combination in patients with NSCLC;Timepoint(s) of evaluation of this end point: Phase I : June 2011 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - To describe the dose limiting toxicity of the MM-121 + erlotinib combination - To determine the adverse event profile of the MM-121 + erlotinib combination - To determine the pharmacokinetic parameters and immunogenicity of the MM-121 + erlotinib combination - To obtain an initial estimate of other key efficacy endpoints (objective response rate, disease control rate, overall survival and overall PFS) in this population for use in planning subsequent randomized phase 2/3 trials - To gather exploratory clinical data on a potentially predictive set of biomarkers to be measured in serum and tumor tissue;Timepoint(s) of evaluation of this end point: December 2012 | — |
Countries
Canada, Germany, Hong Kong, Korea, Democratic People's Republic of, Spain, Taiwan, United States
Contacts
Public ContactMerrimack MM121 Clinical Trial Mger
MERRIMACK PHARMACEUTICALS
Outcome results
None listed