M402 in Combination With Nab-Paclitaxel and Gemcitabine in Pancreatic Cancer
NCT ID: NCT01621243
Last Updated: 2018-08-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1/PHASE2
128 participants
INTERVENTIONAL
2012-05-31
2016-10-24
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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nab-paclitaxel, gemcitabine, placebo
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.
nab-paclitaxel
nab-paclitaxel dosed on Day 1, Day 8, Day 15 of each 28-day cycle
gemcitabine
gemcitabine will be dosed on Day 1, Day 8, Day 15 of each 28-day cycle
placebo
Placebo will be dosed daily
nab-paclitaxel, gemcitabine, necuparanib
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.
nab-paclitaxel
nab-paclitaxel dosed on Day 1, Day 8, Day 15 of each 28-day cycle
gemcitabine
gemcitabine will be dosed on Day 1, Day 8, Day 15 of each 28-day cycle
Necuparanib
Necuparanib will be dosed daily
Interventions
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nab-paclitaxel
nab-paclitaxel dosed on Day 1, Day 8, Day 15 of each 28-day cycle
gemcitabine
gemcitabine will be dosed on Day 1, Day 8, Day 15 of each 28-day cycle
placebo
Placebo will be dosed daily
Necuparanib
Necuparanib will be dosed daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Momenta Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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James Roach, MD
Role: STUDY_DIRECTOR
Momenta Pharmaceuticals
Locations
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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
Montefiore Medical Center
The Bronx, New York, United States
Ohio State University
Columbus, Ohio, United States
Northwest Cancer Specialists
Portland, Oregon, United States
Penn State Hershey Cancer Center
Hershey, Pennsylvania, United States
Cancer Center of the Carolinas/ITOR
Greenville, South Carolina, United States
University of Texas Health Sciences Center
San Antonio, Texas, United States
Texas Oncology, P.A.
Tyler, Texas, United States
Texas Oncology
Tyler, Texas, United States
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States
The Ottawa Hospital Cancer Center
Ottawa, Ontario, Canada
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
CHUM Hospital St-Luc
Montreal, Quebec, Canada
Countries
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References
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O'Reilly EM, Barone D, Mahalingam D, Bekaii-Saab T, Shao SH, Wolf J, Rosano M, Krause S, Richards DA, Yu KH, Roach JM, Flaherty KT, Ryan DP. Randomised phase II trial of gemcitabine and nab-paclitaxel with necuparanib or placebo in untreated metastatic pancreas ductal adenocarcinoma. Eur J Cancer. 2020 Jun;132:112-121. doi: 10.1016/j.ejca.2020.03.005. Epub 2020 Apr 28.
O'Reilly EM, Roach J, Miller P, Yu KH, Tjan C, Rosano M, Krause S, Avery W, Wolf J, Flaherty K, Nix D, Ryan DP. Safety, Pharmacokinetics, Pharmacodynamics, and Antitumor Activity of Necuparanib Combined with Nab-Paclitaxel and Gemcitabine in Patients with Metastatic Pancreatic Cancer: Phase I Results. Oncologist. 2017 Dec;22(12):1429-e139. doi: 10.1634/theoncologist.2017-0472. Epub 2017 Nov 20.
Other Identifiers
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M402-103
Identifier Type: -
Identifier Source: org_study_id
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