Spots Global Cancer Trial Database for PEGPH20 Plus Nab-Paclitaxel Plus Gemcitabine Compared With Nab-Paclitaxel Plus Gemcitabine in Participants With Stage IV Untreated Pancreatic Cancer
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Trial Identification
Brief Title: PEGPH20 Plus Nab-Paclitaxel Plus Gemcitabine Compared With Nab-Paclitaxel Plus Gemcitabine in Participants With Stage IV Untreated Pancreatic Cancer
Official Title: A Phase 2, Randomized, Multicenter Study of PEGPH20 (PEGylated Recombinant Human Hyaluronidase) Combined With Nab-Paclitaxel Plus Gemcitabine Compared With Nab-Paclitaxel Plus Gemcitabine in Subjects With Stage IV Previously Untreated Pancreatic Cancer
Study ID: NCT01839487
Conditions
Study Description
Brief Summary: This study is designed to compare the treatment effect of PEGPH20 combined with nab-paclitaxel (NAB) and gemcitabine (GEM) \[PAG\] to NAB and GEM \[AG\] in participants with Stage IV previously untreated pancreatic ductal adenocarcinoma (PDA). The study will have 2 run-in phases, one for each formulation of PEGPH20 (original and new formulations), and a Phase 2 portion. The 2 run-in phases will evaluate the safety and tolerability of the PAG treatment using the original and new succinic acid PEGPH20 formulation, respectively, compared with AG treatment. Phase 2 will have 2 stages due to a partial clinical hold that occurred from April through July 2014. The participants will be randomized in 3:1 for the run-in phases. The first stage will randomize participants in a 1:1 ratio. The second stage will randomize participants in a 2:1 ratio (PAG:AG). This is an open-label study. To minimize bias to the progression-free survival endpoint, disease progression will be based on the assessment of the Central Imaging Reader (CIR). Determination of clinical progression by the Investigator without corresponding CIR confirmation will be documented with the relevant signs and symptoms.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Alabama Oncology, Birmingham, Alabama, United States
University of South Alabama Mitchell Cancer Institute, Mobile, Alabama, United States
Banner MD Anderson Cancer Center, Gilbert, Arizona, United States
Mayo Clinic - Scottsdale, Scottsdale, Arizona, United States
Arizona Oncology Associates, PC, Tucson, Arizona, United States
Highlands Oncology Group, Fayetteville, Arkansas, United States
Providence St Joseph Medical Center, Burbank, California, United States
Scripps Cancer Center, La Jolla, California, United States
UCSD - Moore's Cancer Center, La Jolla, California, United States
Cedars-Sinai Medical Center, Los Angeles, California, United States
University of California Medical Center, Orange, California, United States
Saint Helena Hospital, Saint Helena, California, United States
Pacific Hematology Oncology Associates, San Francisco, California, United States
The Oncology Institute of Hope and Innovation, Whittier, California, United States
University of Colorado Cancer Center, Aurora, Colorado, United States
Rocky Mountain Cancer Center, Denver, Colorado, United States
Stamford Hospital, Stamford, Connecticut, United States
Georgetown University Medical Center, Washington, District of Columbia, United States
University of Miami, Sylvester comprehensive Cancer Center, Miami, Florida, United States
H. Lee Moffit Cancer Center, Tampa, Florida, United States
Piedmont Hospital, Atlanta, Georgia, United States
Loyola University Medical Center, Maywood, Illinois, United States
Norton Cancer Institute - Norton HealthCare Pavilion, Louisville, Kentucky, United States
Johns Hopkins University Hospital, Baltimore, Maryland, United States
Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States
Lahey Clinic, Burlington, Massachusetts, United States
University of Mass Medical School, Worcester, Massachusetts, United States
University of Michigan, Ann Arbor, Michigan, United States
Virginia Piper Cancer Institute, Minneapolis, Minnesota, United States
Unniversity of Minnesota, Minneapolis, Minnesota, United States
Research Medical Center, Kansas City, Missouri, United States
Washington University School of Medicine, Saint Louis, Missouri, United States
Comprehensive Cancer Centers of Nevada, Las Vegas, Nevada, United States
St. Joseph's Regional Medical Center, Paterson, New Jersey, United States
Roswell Park Cancer Institute, Buffalo, New York, United States
North Shore Long Island Jewish Health System, Lake Success, New York, United States
Mount Sinai Medical Center, New York, New York, United States
Columbia University Medical Center, New York, New York, United States
University of Rochester, Rochester, New York, United States
Gabrail Cancer Center, Canton, Ohio, United States
University of Oklahoma Health Science Center, Oklahoma City, Oklahoma, United States
UPMC Cancer Center, Pittsburgh, Pennsylvania, United States
Greenville Health System, Greenville, South Carolina, United States
Texas Oncology - Baylor, Dallas, Texas, United States
Cancer Care Centers of South Texas, New Braunfels, Texas, United States
Texas Oncology, Tyler, Texas, United States
Columbia Basin Hematology and Oncology, Kennewick, Washington, United States
Seattle Cancer Care Alliance, Seattle, Washington, United States
NorthWest Medical Specialties, PLLC, Tacoma, Washington, United States
University of Wisconsin Hospitals and Clinics, Madison, Wisconsin, United States
Froedtert Hospital, Medical College of Wisconsin, Milwaukee, Wisconsin, United States
Contact Details
Name: VP, Clinical Development
Affiliation: Halozyme Therapeutics
Role: STUDY_DIRECTOR
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