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
inclusion/exclusion criteria.
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
alone
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.
Key
Interventional
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.
12 months
Yes
Joy Zhu, MD, Ph.D
Study Director
Halozyme Therapeutics
United States: Food and Drug Administration
HALO-109-202
NCT01839487
April 2013
September 2015
Name | Location |
---|---|
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 |