Clinical trialPhase 2Completed

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

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

NCT01839487 ↗ ClinicalTrials.gov, retrieved 6 November 2026

Outcome: Outcome unknown
Phase: Phase 2
Status: Completed
Study type: Interventional
Start: 14 May 2013
Expected end: 26 September 2018
Enrollment: 279 participants
Sites: 51
Primary outcomes: Progression-Free Survival (PFS); Percentage of Participants in the PAG Arm Who Experienced Any Thromboembolic (TE) Event in Stage 2 of the Study
Sponsor: Industry
Results posted: 2020-07-20
Last update: 20 July 2020

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Brief summary public domain (ClinicalTrials.gov)

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.

Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)

Progression-Free Survival (PFS) [From the date of randomization until disease progression or death from any cause (maximum exposure: 30.72 months for PAG, and 20.27 months for AG)]. Median, months (95% Confidence Interval). PAG: PEGPH20 + Nab-paclitaxel + Gemcitabine (n=139): 6.05 (5.36 to 7.20); AG: Nab-paclitaxel + Gemcitabine (n=92): 5.26 (3.91 to 6.54). Analysis, PAG: PEGPH20 + Nab-paclitaxel + Gemcitabine vs AG: Nab-paclitaxel + Gemcitabine: Hazard Ratio (HR) 0.74 (95% CI 0.54 to 1.01); p=0.058; Log Rank; other.

Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)

Percentage of Participants in the PAG Arm Who Experienced Any Thromboembolic (TE) Event in Stage 2 of the Study [From first exposure to any study drug (PEGPH20, NAB, GEM) through 30 days after end of treatment visit (maximum exposure: 30.72 months for PAG)]. Number, percentage of participants. PAG: PEGPH20 + Nab-paclitaxel + Gemcitabine (n=86): 14.0.