Ignite Creation Date:
2024-05-06 @ 1:31 AM
Last Modification Date:
2024-10-26 @ 11:06 AM
Study NCT ID:
NCT01839487
Status:
COMPLETED
Last Update Posted:
2020-07-20
First Post:
2013-04-22
Brief Title:
PEGPH20 Plus Nab-Paclitaxel Plus Gemcitabine Compared With Nab-Paclitaxel Plus Gemcitabine in Participants With Stage IV Untreated Pancreatic Cancer
Sponsor:
Halozyme Therapeutics
Organization:
Halozyme Therapeutics
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2020-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 31 for the run-in phases The first stage will randomize participants in a 11 ratio The second stage will randomize participants in a 21 ratio PAGAG
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
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 31 for the run-in phases The first stage will randomize participants in a 11 ratio The second stage will randomize participants in a 21 ratio PAGAG
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None