A Phase 1-2 Trial of MM-121 in Combination With Erlotinib in Three Groups of Patients With Non-Small Cell Lung Cancer
18 Years
N/A
Both
Carcinoma, Non-Small-Cell Lung
Trial Information
A Phase 1-2 Trial of MM-121 in Combination With Erlotinib in Three Groups of Patients With Non-Small Cell Lung Cancer
Phase 1: Patients with Non-Small Cell Lung Cancer (NSCLC) may be enrolled to evaluate the
safety, tolerability and recommended Phase 2 dose of MM-121 in combination with standard
therapy.
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.
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.
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.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Phase 1: 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.
Outcome Time Frame:
June 2011
Safety Issue:
Yes
Principal Investigator
Victor Moyo, MD
Investigator Role:
Study Director
Investigator Affiliation:
Merrimack Pharmaceuticals
Authority:
United States: Food and Drug Administration
Study ID:
MM-121-01-101 (ARD11585)
NCT ID:
NCT00994123
Start Date:
February 2010
Completion Date:
December 2013
Related Keywords:
- Carcinoma, Non-Small-Cell Lung
- Non-Small Cell Lung Cancer
- NSCLC
- Advanced Non-Small Cell Lung Cancer
- Metastatic Non-Small Cell Lung Cancer
- Lung Cancer
- Erlotinib
- Tarceva
- MM-121
- ErbB3
- Her3
- Epidermal Growth Factor Receptor
- anti-ErbB3 human monoclonal antibody
- ErbB3 antagonist
- Carcinoma
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
Name | Location |
|---|---|
| Albany, Georgia 31701 | |
| Birmingham, Alabama 35294 | |
| Phoenix, Arizona 85012 | |
| Fountain Valley, California 92708 | |
| Miami, Florida 33176 | |
| Columbia, Missouri 65203 | |
| Albany, New York 12208 | |
| Cleveland, Ohio 44195 | |
| Philadelphia, Pennsylvania 19104 | |
| Nashville, Tennessee 37203-1632 | |
| Austin, Texas 78705 | |
| Denver, Colorado | |
| Boston, Massachusetts | |
| Eugene, Oregon | |
| Indianapolis, Indiana | |
| Charleston, South Carolina |
