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
1. Phase 2, multicenter open-label randomized study with a run-in phase. Run-in phase to
evaluate safety and tolerability of PEGPH20 + Nab-paclitaxel + Gemcitabine vs.
Nab-paclitaxel + Gemcitabine. Phase 2 will be an open-label randomized study with same
study drugs evaluating safety and efficacy.
2. Subjects must have newly diagnosed stage 4 untreated metastatic pancreatic ductal
cancer diagnosed by a standard of Care CT scan within 20 days of dosing and meet all
3. Treatment consists of 4 week treatment cycles with Week 4 of every cycle, a wash-out
week. In Cycle 1, PEGPH20 will be administered twice per week with Nab-paclitaxel +
Gemcitabine given once/week 2-4 hrs. after PEGPH20 and nab-paclitaxel + gemcitabine
4. Safety parameters include medical history, physical exams, adverse event and
Concomitant med collection, Karnofsky Performance scale, Immunogenicity, Hematology,
Chemistry, coagulation, Weight/body surface area (BSA) for dosing, ECG and
pharmacokinetics (PK) and Hyaluronan (HA) catabolite levels. Efficacy parameters
include standard of care CT scans, CA19-9, tumor analysis of HA.
5. Subjects continue in study until disease progression, adverse event/toxicity, death or
either the subject/sponsor discontinues the study.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression Free Survival
Measured from date of randomization until disease progression or death.
Joy Zhu, MD, Ph.D
United States: Food and Drug Administration
|Virginia Piper Cancer Institute||Minneapolis, Minnesota 55407|
|Comprehensive Cancer Centers of Nevada||Las Vegas, Nevada 89109|
|Rocky Mountain Cancer Center||Denver, Colorado 80218|
|Seattle Cancer Care Alliance||Seattle, Washington 98109|
|Highlands Oncology Group||Springdale, Arkansas 72764|
|Northwest Medical Specialties, PLLC||Tacoma, Washington 98405|
|Texas Oncology||Dallas, Texas|
|Stamford Hospital||Stamford, Connecticut 06904|
|North Shore Long Island Jewish Health System||Lake Success, New York 11042|
|University of California Medical Center||San Francisco, California 94143|
|UPMC Cancer Center||Pittsburgh, Pennsylvania 15232|
|Froedtert Hospital, Medical College of Wisconsin||Milwaukee, Wisconsin 53226|
|Johns Hopkins University Hospital||Baltimore, Maryland|
|Alabama Oncology||Bessemer, Alabama 35022|
|Providence St Joseph Medical Center||Burbank, California 91505|
|Texas Oncology - Baylor||Dallas, Texas 75246|