A Phase IB/II Study of OMP-59R5 with Gemcitabine in Patients with Previously Untreated Metastatic Pancreatic Cancer

Protocol
12-234
Full Title
A Phase Ib/2 Study of OMP-59R5 in Combination with Nab-Paclitaxel and Gemcitabine in Subjects with Previously Untreated Stage IV Pancreatic Cancer
Phase
I/II
Purpose

Gemcitabine is the standard chemotherapy for advanced pancreatic cancer, but despite this treatment, many patients do not survive the disease. The purpose of this study is to find the highest dose of an investigational drug called OMP-59R5 that can be given safely with gemcitabine in patients with pancreatic cancer that has spread (metastasized) to other parts of the body and has not yet been treated.

OMP-59R5 works by targeting cancer stem cells. These stem cells grow more slowly than regular cancer cells and evade the effects of conventional chemotherapy, which targets fast-growing cells such as cancer cells. As a result, cancer stem cells can later develop into regular cancer cells, and cause a recurrence of the disease after therapy. It is hoped that giving OMP-59R5 with gemcitabine will be more effective than gemcitabine alone for patients with advanced pancreatic cancer.

OMP-59R5 and gemcitabine are both given intravenously (by vein).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have stage IV pancreatic cancer that has not yet been treated.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • This study is open to patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Eileen O’Reilly at 646-888-4182.

Disease(s)
Hepatobiliary: Pancreatic Cancer
Upper Gastrointestinal: Pancreatic Cancer
Locations
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