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Eligibility
for people ages 18 years and up
Location
at San Francisco, California and other locations
Dates
study started
estimated completion:
Principal Investigator

Description

Summary

The purpose of this study is to determine whether the combination of MM-141 plus nab-paclitaxel and gemcitabine is more effective than nab-paclitaxel and gemcitabine alone based on Progression Free Survival (PFS) in front-line metastatic pancreatic cancer patients with high serum levels of free IGF-1.

Official Title

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

Details

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. All patients will be initially screened for free IGF-1 status. Eligible patients with high free IGF-1 will be randomized to receive MM-141 plus nab-paclitaxel and gemcitabine or placebo plus nab-paclitaxel and gemcitabine and patients. Patients with low free IGF-1 or patients who have high free IGF-1 but are not otherwise eligible will be followed in an observational group.

Keywords

Pancreatic Cancer Front-line Pancreatic Cancer Metastatic Pancreatic Cancer Gemcitabine Nab-paclitaxel Abraxane Free IGF-1 Heregulin Paclitaxel Albumin-Bound Paclitaxel

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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.
  • Blood sample sent for free IGF-1 testing
  • ECOG performance status (PS) of 0 or 1

You CAN'T join if...

  • Patients who only present with localized disease
  • Patients with CNS malignancies (primary or metastatic)
  • Clinically significant cardiac disease

Locations

  • Pacific Cancer Medical Center, Inc. accepting new patients
    Anaheim, California, 92801, USA
  • St. Jude Heritage Healthcare accepting new patients
    Fullerton, California, 92835, USA
  • UCLA School of Medicine accepting new patients
    Los Angeles, California, 90095, USA
  • Cancer Care Assoc Med Grp accepting new patients
    Redondo Beach, California, 90277, USA
  • Sansum Clinic accepting new patients
    Santa Barbara, California, 93105, USA
  • Central Coast Med Onc Corp accepting new patients
    Santa Maria, California, 93454, USA

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Merrimack Pharmaceuticals
ID
NCT02399137
Phase
Phase 2
Lead Scientist
Andrew Ko
Study Type
Interventional
Last Updated
December 2016
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