Metastatic Pancreatic Cancer Clinical Trial
Official title:
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
This study is designed to compare the treatment effect of PEGPH20 combined with
nab-paclitaxel (NAB) and gemcitabine (GEM) [PAG] to NAB and GEM [AG] in participants with
Stage IV previously untreated pancreatic ductal adenocarcinoma (PDA).
The study will have 2 run-in phases, one for each formulation of PEGPH20 (original and new
formulations), and a Phase 2 portion. The 2 run-in phases will evaluate the safety and
tolerability of the PAG treatment using the original and new succinic acid PEGPH20
formulation, respectively, compared with AG treatment. Phase 2 will have 2 stages due to a
partial clinical hold that occurred from April through July 2014. The participants will be
randomized in 3:1 for the run-in phases. The first stage will randomize participants in a 1:1
ratio. The second stage will randomize participants in a 2:1 ratio (PAG:AG).
This is an open-label study. To minimize bias to the progression-free survival endpoint,
disease progression will be based on the assessment of the Central Imaging Reader (CIR).
Determination of clinical progression by the Investigator without corresponding CIR
confirmation will be documented with the relevant signs and symptoms.
n/a
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