28
Participants
Start Date
September 30, 2011
Primary Completion Date
February 28, 2014
Study Completion Date
May 31, 2015
Gemcitabine
1000 mg/m2 given IV one time a week (Cycle 1: 7 weeks on treatment, 1 week off treatment; Cycle 2+: 3 Weeks on treatment, 1 week off treatment)
PEGPH20
(Cycle 1: 7 weeks on treatment/1 week off treatment; Cycle 2+: 3 Weeks on treatment/1 week off treatment). Doses start at 1.0 mcg/kg and modified until recommended Phase 2 dose is determined. Treatment continues until occurrence of significant treatment-related toxicity, progressive disease, or discontinuation criteria are met
Placebo
(Cycle 1: 7 weeks on treatment/1 week off treatment; Cycle 2+: 3 Weeks on treatment/1 week off treatment).
Mount Sinai School of Medicine, New York
NSLIJ Health System, Monter Cancer Center, New Hyde Park
SUNY Upstate Medical University, Syracuse
Indiana University Melvin and Bren Simon Cancer Center, Indianapolis
Highlands Oncology Group, Fayetteville
Seattle Cancer Care Alliance, Seattle
California Pacific Medical Center, San Francisco
UMDNJ - New Jersey Medical School, Newark
Chelyabinsk Regional Clinical Oncology Center, Chelyabinsk
Russian Oncological Research Center n.a. N.N. Blokhin, Moscow
Medical Radiological Research Center, Obninsk
Omsk Regional Budget Medical Institution, Omsk
Lead Sponsor
Halozyme Therapeutics
INDUSTRY