A Randomized, Double-blind, Placebo-controlled Phase 2 Study of MM-141 plus Nab-Paclitaxel and Gemcitabine versus Nab-Paclitaxel and Gemcitabine in Front-line Metastatic Pancreatic Cancer

Protocol: 
AAAQ0008
Phase: 
II

A Randomized, Double-blind, Placebo-controlled Phase 2 Study of MM-141 plus Nab-Paclitaxel and Gemcitabine versus Nab-Paclitaxel and Gemcitabine in Front-line Metastatic Pancreatic Cancer

Insulin-like growth factor 1 (IGF-1) and heregulin (HRG) are proteins in the blood that can bind to two receptors on tumor cells called insulin like growth factor 1 receptor (IGF-1R) and epidermal growth factor receptor 3 (ErbB3), respectively. When IGF-1 binds to IGF-1R and/or HRG binds to ErbB3, it causes some tumors to grow and not respond well to chemotherapy. The study drug, MM-141, is a monoclonal antibody that blocks both IGF-1R and ErbB3 at the same time. In this study, MM-141 is being combined with nab-paclitaxel and gemcitabine. In newly diagnosed pancreatic cancer patients, approximately 60% of those tested have high free IGF-1 levels in their blood. Because MM-141 also targets IGF-1R, only those patients with high free IGF-1 levels will be able to get treated on this study. This is a randomized, double-blind, placebo-controlled Phase 2 study of MM-141 plus nab-paclitaxel and gemcitabine or placebo plus nab-paclitaxel and gemcitabine in front-line metastatic pancreatic cancer patients.

Are you Eligible? (Inclusion Criteria)

- Metastatic adenocarcinoma of the pancreas. Patients with islet cell neoplasms are not eligible.
- Patient must have received no prior radiotherapy, surgery, chemotherapy, or investigational therapy for the treatment of metastatic disease. Prior systemic treatment in the adjuvant setting
is only allowed if administered as a radiation sensitizer and if it was
provided > 6 months prior to enrollment onto this study.
- High serum levels of free IGF-1, defined as >= 0.390 ng/ml.
- Measureable disease in accordance with RECIST v1.1

Specialty Area(s)

Trial Location

Herbert Irving Comprehensive Cancer Center
161 Fort Washington Ave.
Herbert Irving Pavilion
New York, NY 10032
United States