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Protocol No. 2013IS030 Principal Investigator Greeno, Edward
Phase Phase II
Age Group Adult Scope National
Secondary Protocol No. HALO-109-202
Title A Phase II, Randomized, Multicenter Study of PEGPH20 (PEGylated Recombinant Human Hyaluronidase) Combined with nab-Paclitaxel Plus Gemcitabine Compared With nab-Paclitaxel Plus Gemcitabine in Subject with Stage IV previously untreated Pancreatic Cancer (HALO-109-202)
Objective Primary • To estimate the progression-free survival (PFS) duration of PEGPH20 combined with nab-paclitaxel (NAB) plus gemcitabine (GEM) (PAG treatment). Secondary • To estimate the relative benefit of PAG treatment versus NAB plus GEM (AG treatment), as assessed by the PFS hazard ratio. • To estimate the relative benefit of PAG treatment versus AG treatment, as assessed by the PFS hazard ratio based on subject tumor-associated hyaluronan (HA) levels. • To estimate the objective response rate (ORR), as defined by the Response Evaluation Criteria in Solid Tumors (RECIST v1.1), of PAG treatment and the relative benefit of PAG treatment versus AG treatment. • To estimate the overall survival (OS) duration of PAG treatment and the relative benefit of PAG treatment versus AG treatment, as assessed by the OS hazard ratio. • To evaluate the safety and tolerability profile of the PAG and AG treatment groups. • To characterize the plasma pharmacok
Treatment PEGPH20 (PEGylated Recombinant Human Hyaluronidase) Combined with nab-Paclitaxel Plus Gemcitabine Compared With nab-Paclitaxel Plus Gemcitabine
Applicable Disease Sites Pancreas
Status Open
Participating Institutions Masonic Cancer Center
Treatment Type Treatment
Contact Carrie McCann Phone:612-626-2569
Email:mcca0313@umn.edu
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