M402 in Combination With Nab-Paclitaxel and Gemcitabine in Pancreatic Cancer
Metastatic Pancreatic Cancer
About this trial
This is an interventional treatment trial for Metastatic Pancreatic Cancer focused on measuring necuparanib, gemcitabine, heparin, low molecular weight heparin, nab-Paclitaxel
Eligibility Criteria
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
Sites / Locations
- University of Alabama at Birmingham Comprehensive Cancer Center
- Clearview Cancer Institute
- Arizona Clinical Research Center
- University of Arizona
- University of Colorado School of Medicine - Division of Medical Oncology
- Poudre Valley Health System
- Hartford Healthcare Cancer Institute at Midstate Medical Center
- Florida Hospital Tampa
- Southeastern Regional Medical Center
- Illinois Cancer Specialists
- Loyola University Medical Center
- Crescent City Research Consortium
- Ochsner Medical Center
- University of Maryland- St Joseph's Medical Center
- Massachusetts General Hospital
- Dana-Farber Cancer Institute
- Umass Memorial Medical Center
- St. Joseph Mercy Hospital
- Karmanos Cancer Center
- Mayo Clinic
- Metro-Minnesota Community Clinical Oncology Program
- University of Kansas Cancer Center
- University of New Mexico Cancer Center
- Montefiore-Einstein Center for Cancer Care
- Montefiore Medical Center
- Memorial Sloan Kettering Cancer Center
- Ohio State University
- Northwest Cancer Specialists
- Penn State Hershey Cancer Center
- Cancer Center of the Carolinas/ITOR
- University of Texas Health Sciences Center
- Texas Oncology, P.A.
- Texas Oncology
- University of Wisconsin Hospital and Clinics
- The Ottawa Hospital Cancer Center
- Sunnybrook Health Sciences Centre
- CHUM Hospital St-Luc
Arms of the Study
Arm 1
Arm 2
Placebo Comparator
Experimental
nab-paclitaxel, gemcitabine, placebo
nab-paclitaxel, gemcitabine, necuparanib
Part A: Not applicable. Part B: nab-paclitaxel, gemcitabine, and placebo. Placebo administered daily along with nab-paclitaxel and gemcitabine administration on Day 1, Day 8, and Day 15 of each 28-day cycle.
Part A: Following a single-dose of necuparanib and a 7-day follow-up period, necuparanib was administered daily along with nab-paclitaxel and gemcitabine administration on Day 1, Day 8, and Day 15 of each 28-day cycle. Dose escalation of necuparanib proceeded by cohort in a 3+3 design. Part B: A fixed dose of necuparanib will be administered daily along with nab-paclitaxel and gemcitabine administration on Day 1, Day 8, and Day 15 of each 28-day cycle.