Halozyme Therapeutics Inc (HALO)

[rod5247]

PEGPH20 Plus Nab-Paclitaxel Plus Gemcitabine Compared With Nab-Paclitaxel Plus Gemcitabine in Subjects With Stage IV Untreated Pancreatic Cancer

Condition:
Metastatic Pancreatic Cancer

Interventions:
Drug: PEGPH20+nab-paclitaxel+gemcitabine; Drug: nab-paclitaxel + gemcitabine

Study Type:
Interventional

Phase:
Phase 2

Sponsor:
Halozyme Therapeutics

Funder Type:
Industry

Study Design:
Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Primary Purpose: Treatment; Masking: Open Label

Outcome Measures:
Estimate the PFS duration of PEGPH20 combined with NAB plus GEM; Estimate relative benefit of PAG treatment vs. AG treatment, as assessed by the PFS ratio; Estimate relative benefit of PAG vs AG treatment as assessed by the PFS hazard ratio based on subject tumor-associated HA levels; Estimate ORR as defined by RECIST 1.1 of PAG treatment and the relative benefit of PAG treatment vs AG treatment; To estimate the OS duration of PAG treatment and the relative benefit of PAG treatment vs AG treatment, as assessed by the OS hazard ratio.; To evaluate the safety and tolerability profile of PAG and AG treatment groups; To characterize the plasma PK of PEGPH20 when given in combination with NAB + GEM

Your turn, what are you talking about?