M402 in Combination With Nab-Paclitaxel and Gemcitabine in Pancreatic Cancer
Conditions
Metastatic Pancreatic Cancer
Conditions: official terms
Pancreatic Neoplasms
Conditions: Keywords
necuparanib, gemcitabine, heparin, low molecular weight heparin, nab-Paclitaxel
Study Type
Interventional
Study Phase
Phase 1/Phase 2
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Intervention
Name: nab-paclitaxel Type: Drug
Name: gemcitabine Type: Drug
Name: placebo Type: Drug
Name: Necuparanib Type: Drug
Overall Status
Recruiting
Summary
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.
Detailed Description
Part A was an open-label, multiple ascending dose patient study of necuparanib given first as a single dose and then daily in combination with the nab-paclitaxel and gemcitabine regimen. It was conducted to evaluate the safety and tolerability of necuparanib alone and in combination with nab-paclitaxel and gemcitabine and to recommend a necuparanib dose regimen for subsequent evaluation in Part B. Part B is a randomized, double-blind study investigating the antitumor activity of necuparanib in combination with nab-paclitaxel and gemcitabine compared with nab-paclitaxel, gemcitabine, and placebo. In both Parts A and B, a treatment period consists of one 28-day cycle. The Study Patient and Investigator can decide to continue with additional 28-day cycles according to the patient's status at the end of each 28-day cycle. Part A has completed enrollment and Part B is currently open.

Part A - Primary Objectives:

- To evaluate the safety and tolerability of necuparanib in combination with nab-paclitaxel and gemcitabine.

- To determine the dose of necuparanib to be carried forward into Part B.

Part B - Primary Objective:

To evaluate overall survival in patients treated with necuparanib + nab-paclitaxel + gemcitabine compared with placebo + nab-paclitaxel + gemcitabine.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
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
Locations
University of Alabama
Birmingham, Alabama, United States
Status: Recruiting
Clearview Cancer Institute
Huntsville, Alabama, United States
Status: Recruiting
Arizona Clinical Research Center
Tucson, Arizona, United States
Status: Recruiting
University of Arizona Cancer Center
Tucson, Arizona, United States
Status: Recruiting
Disney Family Cancer Center
Burbank, California, United States
Status: Recruiting
Poudre Valley Health System
Fort Collins, Colorado, United States
Status: Recruiting
Cancer Center of Central Connecticut
Southington, Connecticut, United States
Status: Recruiting
Advanced Medical Specialties
Miami, Florida, United States
Status: Recruiting
Southeastern Regional Medical Center
Newnan, Georgia, United States
Status: Recruiting
Illinois Cancer Specialists
Arlington Heights, Illinois, United States
Status: Recruiting
Loyola University
Maywood, Illinois, United States
Status: Recruiting
Crescent City Research Consortium
Marrero, Louisiana, United States
Status: Recruiting
Ochsner Medical Center
New Orleans, Louisiana, United States
Status: Recruiting
University of Maryland- St Joseph's Medical Center
Towson, Maryland, United States
Status: Recruiting
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Status: Recruiting
Massachusetts General Hospital
Boston, Massachusetts, United States
Status: Recruiting
St. Joseph Mercy Hospital
Ann Arbor, Michigan, United States
Status: Recruiting
Karmanos Cancer Center
Detroit, Michigan, United States
Status: Recruiting
Saint Mary's Mercy Health
Grand Rapids, Michigan, United States
Status: Recruiting
Metro-Minnesota Community Clinical Oncology Program
St. Louis Park, Minnesota, United States
Status: Recruiting
University of Kansas Cancer Center
Kansas City, Missouri, United States
Status: Recruiting
Missouri Baptist
St. Louis, Missouri, United States
Status: Recruiting
Montana Cancer Consortium
Billings, Montana, United States
Status: Recruiting
Nebraska Cancer Specialists
Omaha, Nebraska, United States
Status: Recruiting
Montefiore Medical Center
Bronx, New York, United States
Status: Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Status: Recruiting
Novant Health Oncology Specialists
Winston-Salem, North Carolina, United States
Status: Recruiting
Gabrail Cancer Center
Canton, Ohio, United States
Status: Completed
Ohio State University
Columbus, Ohio, United States
Status: Recruiting
Northwest Cancer Specialists
Portland, Oregon, United States
Status: Recruiting
Penn State Hershey Cancer Center
Hershey, Pennsylvania, United States
Status: Recruiting
Institute of Translational Oncology Research
Greenville, South Carolina, United States
Status: Recruiting
The Jones Cancer Clinic
Germantown, Tennessee, United States
Status: Recruiting
Texas Oncology P.A.
Bedford, Texas, United States
Status: Recruiting
Texas Oncology
Dallas, Texas, United States
Status: Recruiting
Texas Oncology
Fort Worth, Texas, United States
Status: Recruiting
University of Texas Health Sciences Center
San Antonio, Texas, United States
Status: Recruiting
Texas Oncology, P.A.
Tyler, Texas, United States
Status: Recruiting
Virginia Oncology Associates
Norfolk, Virginia, United States
Status: Recruiting
Start Date
May 2012
Completion Date
March 2017
Sponsors
Momenta Pharmaceuticals, Inc.
Source
Momenta Pharmaceuticals, Inc.
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page