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

Information source: Momenta Pharmaceuticals, Inc.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Metastatic Pancreatic Cancer

Intervention: nab-paclitaxel (Drug); gemcitabine (Drug); placebo (Drug); Necuparanib (Drug)

Phase: Phase 1/Phase 2

Status: Recruiting

Sponsored by: Momenta Pharmaceuticals, Inc.

Overall contact:
Mary Fons-Colvin, Phone: 919-972-7303, Email: mfcolvin@novellaclinical.com

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.

Clinical Details

Official title: 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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome:

Part A: Safety

Part B: Overall Survival

Secondary outcome:

Part A: Maximum concentration of necuparanib

Part B: Duration of progression-free survival

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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): 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 and Contacts

Mary Fons-Colvin, Phone: 919-972-7303, Email: mfcolvin@novellaclinical.com

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

Additional Information

Starting date: May 2012
Last updated: March 25, 2015

Page last updated: August 23, 2015

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