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.
To evaluate overall survival in patients treated with necuparanib + nab-paclitaxel +
gemcitabine compared with placebo + nab-paclitaxel + gemcitabine.
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
University of Alabama, Birmingham, Alabama 35233, United States; Recruiting
Clearview Cancer Institute, Huntsville, Alabama 35805, United States; Recruiting
Arizona Clinical Research Center, Tucson, Arizona 85715, United States; Recruiting
University of Arizona Cancer Center, Tucson, Arizona 85724, United States; Recruiting
Disney Family Cancer Center, Burbank, California 91505, United States; Recruiting
Poudre Valley Health System, Fort Collins, Colorado 80528, United States; Recruiting
Cancer Center of Central Connecticut, Southington, Connecticut 06849, United States; Recruiting
Advanced Medical Specialties, Miami, Florida 33176, United States; Recruiting
Southeastern Regional Medical Center, Newnan, Georgia 30265, United States; Recruiting
Illinois Cancer Specialists, Arlington Heights, Illinois 60005, United States; Recruiting
Loyola University, Maywood, Illinois 60130, United States; Recruiting
Crescent City Research Consortium, Marrero, Louisiana 70072, United States; Recruiting
Ochsner Medical Center, New Orleans, Louisiana 70121, United States; Recruiting
University of Maryland- St Joseph's Medical Center, Towson, Maryland 21204, United States; Recruiting
Dana-Farber Cancer Institute, Boston, Massachusetts 02215, United States; Recruiting
Massachusetts General Hospital, Boston, Massachusetts 02114, United States; Recruiting
St. Joseph Mercy Hospital, Ann Arbor, Michigan 48105, United States; Recruiting
Karmanos Cancer Center, Detroit, Michigan 48201, United States; Recruiting
Saint Mary's Mercy Health, Grand Rapids, Michigan 49503, United States; Recruiting
Metro-Minnesota Community Clinical Oncology Program, St. Louis Park, Minnesota 55416, United States; Recruiting
University of Kansas Cancer Center, Kansas City, Missouri 64154, United States; Recruiting
Missouri Baptist, St. Louis, Missouri 63131, United States; Recruiting
Montana Cancer Consortium, Billings, Montana 59102, United States; Recruiting
Nebraska Cancer Specialists, Omaha, Nebraska 68114, United States; Recruiting
Montefiore Medical Center, Bronx, New York 10467, United States; Recruiting
Memorial Sloan Kettering Cancer Center, New York, New York 10065, United States; Recruiting
Novant Health Oncology Specialists, Winston-Salem, North Carolina 27103, United States; Recruiting
Gabrail Cancer Center, Canton, Ohio 44718, United States; Completed
Ohio State University, Columbus, Ohio 43210, United States; Recruiting
Northwest Cancer Specialists, Portland, Oregon 97227, United States; Recruiting
Penn State Hershey Cancer Center, Hershey, Pennsylvania 17033, United States; Recruiting
Institute of Translational Oncology Research, Greenville, South Carolina 29605, United States; Recruiting
The Jones Cancer Clinic, Germantown, Tennessee 38138, United States; Recruiting
Texas Oncology P.A., Bedford, Texas 76022, United States; Recruiting
Texas Oncology, Dallas, Texas 75231, United States; Recruiting
Texas Oncology, Fort Worth, Texas 76104, United States; Recruiting
University of Texas Health Sciences Center, San Antonio, Texas 78229, United States; Recruiting
Texas Oncology, P.A., Tyler, Texas 75702, United States; Recruiting
Virginia Oncology Associates, Norfolk, Virginia 23502, United States; Recruiting