PEGPH20 Plus Nab-Paclitaxel Plus Gemcitabine Compared With Nab-Paclitaxel Plus Gemcitabine in Subjects With Stage IV Untreated Pancreatic Cancer

Description

To compare the treatment effect of PEGPH20 combined with nab-paclitaxel and gemcitabine (PAG) to nab-paclitaxel and gemcitabine (AG) in subjects with Stage IV pancreatic cancer. Phase 2 (safety and treatment effect), 124 subjects, 1:1 ratio, PAG:AG, preceded by 8 subject Run-In phase (safety and tolerability).

Study Start Date

April 2013

Estimated Completion Date

July 2016

Interventions

  • Drug: PEGPH20+nab-paclitaxel+gemcitabine
  • Drug: nab-paclitaxel + gemcitabine

Specialties

  • Oncology: Hepatobiliary/Pancreas,Pharmacology/Therapy
  • Pharmacy: Chemotherapy/Oncology,Drug Trials

MeSH Terms

  • Gemcitabine
  • PEGPH20
  • Paclitaxel
  • Pancreatic Neoplasms

Study ID

Halozyme Therapeutics -- HALO-109-202

Status

Unknown

Trial ID

NCT01839487

Study Type

Interventional

Trial Phase

Phase 2

Enrollment Quota

237

Sponsor

Halozyme Therapeutics

Key

Inclusion Criteria

  • Signed Informed consent
  • Histologically confirmed Stage IV pancreatic ductal adenocarcinoma w/ documented disseminated neoplasm to liver and /or lung. Must have archival or fresh tissue (block /slides) available pre-dose.
  • One or more measurable metastatic tumors measurable on CT san per Response Evaluation Criteria in Solid Tumors (RECIST v.1.1 ).
  • No previous radiotherapy, surgery, chemotherapy or investigational therapy for the treatment of metastatic disease.
  • Karnofsky Performance Status >= 70%
  • Life expectancy >= 3 mos
  • Age >= 18 years
  • Screen labs of bilirubin,aspartate transaminase(AST), alanine transaminase(ALT), serum creatinine and albumin, absolute neutrophil count (ANC), hemoglobin, hematocrit and partial thromboplastin time(PTT) within specified values/criteria per protocol prior to dosing. Key

Exclusion Criteria

  • Non metastatic pancreatic ductal adenocarcinoma
  • Known Central nervous system involvement, brain metastasis
  • New York(NY) Heart Assoc Class III or IV cardiac disease or Myocardial infarction within the past 12 months.
  • Active, uncontrolled bacterial, viral or fungal infection requiring systemic therapy.
  • Known infection with human immunodeficiency virus, Hepatitis B, or Hepatitis C
  • History of another primary cancer within the last 3 years with the exception of non-melanoma skin cancer or curatively-treated cervical cancer in-situ.
  • Any other disease, metabolic dysfunction, physical examination finding or clinical lab finding that leads to reasonable suspicion of disease or condition that contraindicates the use of an investigational drug, that may affect interpretation of results, or render the subject at a high risk of treatment complications.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

No

Study Locations and Contact Information (52)

Study Location Distance Name Phone Email
Beth Israel Deaconess Medical Center - Boston, Massachusetts 2.4 miles None None None
Lahey Clinic - Burlington, Massachusetts 11.0 miles None None None
University of Mass Medical School - Worcester, Massachusetts 34.2 miles None None None
Stamford Hospital - Stamford, Connecticut 155.4 miles None None None
North Shore Long Island Jewish Health System - Lake Success, New York 174.6 miles None None None
Columbia University Medical Center - New York, New York 181.2 miles None None None
Mount Sinai Medical Center - New York, New York 183.2 miles None None None
St Josephs Regional Medical Center - Paterson, New Jersey 187.9 miles None None None
University of Rochester - Rochester, New York 335.8 miles None None None
Johns Hopkins University Hospital - Baltimore, Maryland 357.9 miles None None None
Georgetown University Medical Center - Washington, District of Columbia 394.4 miles None None None
Roswell Park Cancer Institute - Buffalo, New York 397.2 miles None None None
UPMC Cancer Center - Pittsburgh, Pennsylvania 478.5 miles None None None
Gabrail Cancer Center - Canton, Ohio 545.3 miles None None None
University of Michigan - Ann Arbor, Michigan 645.2 miles None None None
Carolinas HealthCare System - Charlotte, North Carolina 720.9 miles None None None
Greenville Health System - Greenville, South Carolina 803.9 miles None None None
Norton Cancer Institute Norton HealthCare Pavilion - Louisville, Kentucky 823.2 miles None None None
Loyola University Medical Center - Maywood, Illinois 859.6 miles None None None
Froedtert Hospital Medical College of Wisconsin - Milwaukee, Wisconsin 862.1 miles None None None
University of Wisconsin Hospitals and Clinics - Madison, Wisconsin 932.2 miles None None None
Piedmont Hospital - Atlanta, Georgia 937.2 miles None None None
Washington University School of Medicine - St Louis, Missouri 1,039.5 miles None None None
Alabama Oncology - Birmingham, Alabama 1,049.6 miles None None None
Unniversity of Minnesota - Minneapolis, Minnesota 1,120.0 miles None None None
Virginia Piper Cancer Institute - Minneapolis, Minnesota 1,120.8 miles None None None
H Lee Moffit Cancer Center - Tampa, Florida 1,178.7 miles None None None
University of South Alabama Mitchell Cancer Institute - Mobile, Alabama 1,239.6 miles None None None
Research Medical Center - Kansas City, Missouri 1,249.4 miles None None None
University of Miami Sylvester comprehensive Cancer Center - Miami, Florida 1,259.8 miles None None None
Highlands Oncology Group - Fayetteville, Arkansas 1,305.8 miles None None None
University of Oklahoma Health Science Center - Oklahoma City, Oklahoma 1,493.6 miles None None None
Texas Oncology - Tyler, Texas 1,494.8 miles None None None
Texas Oncology Baylor - Dallas, Texas 1,549.2 miles None None None
Cancer Care Centers of South Texas - New Braunfels, Texas 1,735.5 miles None None None
University of Colorado Cancer Center - Aurora, Colorado 1,759.8 miles None None None
Rocky Mountain Cancer Center - Denver, Colorado 1,766.9 miles None None None
Arizona Oncology Associates PC - Tucson, Arizona 2,280.3 miles None None None
Mayo Clinic Scottsdale - Scottsdale, Arizona 2,280.6 miles None None None
Banner MD Anderson Cancer Center - Gilbert, Arizona 2,285.1 miles None None None
Columbia Basin Hematology and Oncology - Kennewick, Washington 2,360.2 miles None None None
Comprehensive Cancer Centers of Nevada - Las Vegas, Nevada 2,372.5 miles None None None
Seattle Cancer Care Alliance - Seattle, Washington 2,490.2 miles None None None
NorthWest Medical Specialties PLLC - Tacoma, Washington 2,500.9 miles None None None
UCSD Moores Cancer Center - La Jolla, California 2,581.5 miles None None None
Scripps Cancer Center - La Jolla, California 2,583.7 miles None None None
University of California Medical Center - Orange, California 2,585.0 miles None None None
The Oncology Institute of Hope and Innovation - Whittier, California 2,585.9 miles None None None
Providence St Joseph Medical Center - Burbank, California 2,596.7 miles None None None
CedarsSinai Medical Center - Los Angeles, California 2,601.4 miles None None None
Saint Helena Hospital - St. Helena, California 2,679.1 miles None None None
Pacific Hematology Oncology Associates - San Francisco, California 2,698.0 miles None None None

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