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



Status:Terminated
Conditions:Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:8/31/2018
Start Date:May 2012
End Date:October 24, 2016

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A Phase I/II, Two-Part, Multicenter Study to Evaluate the Safety and Efficacy of M402 in Combination With Nab-Paclitaxel and Gemcitabine in Patients With Metastatic Pancreatic Cancer

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.

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.

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
We found this trial at
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Marrero, Louisiana 70072
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1201 Camino de Salud Northeast
Albuquerque, New Mexico 87131
(505) 272-4946
University of New Mexico Cancer Center It’s been 40 years since the New Mexico State...
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
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Boston, MA
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3550 Jerome Avenue
Bronx, New York 10467
(718) 920-4321
Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
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Ann Arbor, Michigan 48197
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Arlington Heights, Illinois 60005
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Aurora, CO
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450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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Boston, MA
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Bronx, NY
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281 W. Lane Ave
Columbus, Ohio 43210
(614) 292-6446
Ohio State University The Ohio State University’s main Columbus campus is one of America’s largest...
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Detroit, Michigan 48202
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Fort Collins, Colorado
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Greenville, South Carolina 29605
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Hershey, Pennsylvania 17033
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Huntsville, Alabama 35805
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Kansas City, Missouri 64154
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600 Highland Ave
Madison, Wisconsin 53792
(608) 263-6400
University of Wisconsin Hospital and Clinics UW Health strives to meet the health needs of...
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2160 South 1st Avenue
Maywood, Illinois 60153
(888) 584-7888
Loyola University Medical Center Loyola University Health System is committed to excellence in patient care...
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Meriden, CT
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1514 Jefferson Hwy.
New Orleans, Louisiana 70121
504-842-3000
Ochsner Medical Center Ochsner Medical Center is located near uptown New Orleans and includes acute...
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1275 York Ave
New York, New York 10021
(212) 639-2000
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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Newnan, Georgia 30265
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Ottawa,
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Portland, Oregon 97213
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Rochester, Minnesota 55905
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Saint Louis Park, Minnesota 55416
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Tampa, Florida 33613
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Tucson, Arizona 85712
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Tucson, Arizona 85721
(520) 621-2211
University of Arizona The University of Arizona is a premier, public research university. Established in...
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Tyler, Texas 75702
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Tyler, Texas 75702
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Worcester, Massachusetts 01605
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