M402 in Combination With Nab-Paclitaxel and Gemcitabine in Pancreatic Cancer

Stopped early · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Metastatic Pancreatic Cancer

In brief

People with primary metastatic pancreatic cancer will be treated with nab-paclitaxel and gemcitabine in combination with an investigational agent called necuparanib (M402). It is made from heparin, which is a well known blood thinner. Blood thinners have been shown in prior animal and human studies to have anti-cancer effects. Necuparanib has been re-engineered from heparin to have much lower blood thinning activity while keeping the anti-tumor activity. The investigators are testing whether necuparanib administered in combination with nab-paclitaxel and gemcitabine may be more effective than nab-paclitaxel and gemcitabine.

Key facts

Study ID

NCT01621243

Run by

Momenta Pharmaceuticals, Inc.

People needed

128

Starts

2012-05-01

Expected to finish

2016-10-24

Last updated by the study team

2018-08-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age of 18 years or older
• Confirmed pancreatic ductal adenocarcinoma
• Metastatic disease as documented by CT scan or MRI (locally advanced disease only NOT eligible)
• At least 1 site of disease measurable by RECIST ver1.1
• ECOG performance status of 0 to 1
• Adequate bone marrow, renal capacity and hepatic function
• Willing to administer daily subcutaneous injections at home

You may not qualify if…

• Any prior radiotherapy, chemotherapy, surgery, or investigational therapy for adjuvant or metastatic pancreatic cancer
• History of suspected history, or presence of heparin induced toxicity (w/ or w/o thrombosis)
• History of unexplained bleeding episodes within 3 months of M402 dosing
• Received thrombolytic agents w/in the previous month
• Had full-dose anticoagulation with heparin, enoxaparin, dalteparin, other LMWH, a/or other anticoagulants w/in 90 days before first dose of M402
• High cardiovascular risk, including but not limited to, recent coronary stenting or myocardial infarction in the past year
• Major trauma or surgery w/in prior 4 weeks

Where it is running

• University of Alabama at Birmingham Comprehensive Cancer Center — Birmingham, Alabama, United States
• Clearview Cancer Institute — Huntsville, Alabama, United States
• Arizona Clinical Research Center — Tucson, Arizona, United States
• University of Arizona — Tucson, Arizona, United States
• University of Colorado School of Medicine - Division of Medical Oncology — Aurora, Colorado, United States
• Poudre Valley Health System — Fort Collins, Colorado, United States
• Hartford Healthcare Cancer Institute at Midstate Medical Center — Meriden, Connecticut, United States
• Florida Hospital Tampa — Tampa, Florida, United States
• Southeastern Regional Medical Center — Newnan, Georgia, United States
• Illinois Cancer Specialists — Arlington Heights, Illinois, United States
• Loyola University Medical Center — Maywood, Illinois, United States
• Crescent City Research Consortium — Marrero, Louisiana, United States
• Ochsner Medical Center — New Orleans, Louisiana, United States
• University of Maryland- St Joseph's Medical Center — Towson, Maryland, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States
• Umass Memorial Medical Center — Worcester, Massachusetts, United States
• St. Joseph Mercy Hospital — Ann Arbor, Michigan, United States
• Karmanos Cancer Center — Detroit, Michigan, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Metro-Minnesota Community Clinical Oncology Program — Saint Louis Park, Minnesota, United States
• University of Kansas Cancer Center — Kansas City, Missouri, United States
• University of New Mexico Cancer Center — Albuquerque, New Mexico, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• Montefiore-Einstein Center for Cancer Care — The Bronx, New York, United States

Full record on ClinicalTrials.gov

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