A Phase I/II Study of M402 in Combination with Gemcitabine in Patients with Previously Untreated Metastatic Pancreatic Cancer

Protocol
12-078
Full Title
A Phase I/II, Two-Part, Multicenter Study to Evaluate the Safety and Efficacy of M402 in Combination with Nab-Paclitaxel and Gemcitabine in Patients with Metastatic Pancreatic Cancer
Phase
I/II
Purpose

Gemcitabine is routinely used to treat pancreatic cancer, but many patients still succumb to the disease. In this study, researchers want to evaluate the safety and effectiveness of combining an investigational drug called M402 with gemcitabine in patients with previously untreated metastatic pancreatic cancer.

M402 is a blood thinner. In this study, a modified form of M402 (which has less blood-thinning properties) is being used, and laboratory studies have shown that it has anticancer effects. The goal of the initial part of the study is to find the highest dose of M402 that can be given safely with gemcitabine in patients.

M402 is an injection that patients (or their caregivers) can give themselves at home. Gemcitabine is given intravenously (by vein) in the clinic.

Eligibility

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

  • Patients must have previously untreated metastatic pancreatic adenocarcinoma.
  • Patients with blood clotting disorders and those on blood thinners may not be able to participate.
  • 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.
  • Patients must be age 18 or older.

For more information about these studies 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
Related Diseases