NCT01839487

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 279 (actual)
• Sponsor: Halozyme Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Metastatic Pancreatic Cancer

Interventions

Type	Name	Description
DRUG	PEGPH20	PEGPH20 will be administered as per the dose and schedule specified in the respective arms.
DRUG	Nab-paclitaxel	Nab-paclitaxel will be administered as per the dose and schedule specified in the respective arms.
DRUG	Gemcitabine	Gemcitabine will be administered as per the dose and schedule specified in the respective arms.
DRUG	Dexamethasone	Dexamethasone will be administered as per the dose and schedule specified in the respective arms.
DRUG	Enoxaparin	Enoxaparin will be administered as per the dose and schedule specified in the respective arms.

Timeline

• Start date: 2013-05-14
• Primary completion: 2018-05-01
• Completion: 2018-09-26
• First posted: 2013-04-25
• Last updated: 2020-07-20
• Results posted: 2020-07-20

Locations

51 sites across 1 country: United States

Regulatory

• FDA-regulated drug study