PEGPH20 Plus Nab-Paclitaxel Plus Gemcitabine Compared With Nab-Paclitaxel Plus Gemcitabine in Participants With Stage IV Untreated Pancreatic Cancer
Completed · Phase 2
Conditions studied: Metastatic Pancreatic Cancer
In brief
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.
Key facts
- Study ID
- NCT01839487
- Run by
- Halozyme Therapeutics
- People needed
- 279
- Starts
- 2013-05-14
- Expected to finish
- 2018-09-26
- Last updated by the study team
- 2020-07-20
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- 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
- Pacific Hematology Oncology Associates — San Francisco, California, United States
- Saint Helena Hospital — St. Helena, 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 D.C., 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
- Alabama Oncology — Birmingham, Alabama, United States
Full record on ClinicalTrials.gov
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