Ignite Creation Date:
2024-05-06 @ 10:27 AM
Last Modification Date:
2024-10-26 @ 12:30 PM
Study NCT ID:
NCT03267940
Status:
TERMINATED
Last Update Posted:
2020-02-07
First Post:
2017-07-25
Brief Title:
Study of PEGPH20 With Cisplatin CIS and Gemcitabine GEM PEGPH20 With Atezolizumab ATEZO CIS and GEM and CIS and GEM Alone in Participants With Previously Untreated Unresectable Locally Advanced or Metastatic Intrahepatic and Extrahepatic Cholangiocarcinoma and Gallbladder Adenocarcinoma
Sponsor:
Halozyme Therapeutics
Organization:
Halozyme Therapeutics
Study Overview
Official Title:
A Phase 1B Randomized Open-Label Study of PEGylated Recombinant Human Hyaluronidase PEGPH20 in Combination With Cisplatin Plus Gemcitabine and PEGPH20 in Combination With Atezolizumab and Cisplatin Plus Gemcitabine Compared With Cisplatin Plus Gemcitabine in Subjects With Previously Untreated Unresectable Locally Advanced or Metastatic Intrahepatic and Extrahepatic Cholangiocarcinoma and Gallbladder Adenocarcinoma
Status:
TERMINATED
Status Verified Date:
2020-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Sponsor decision
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The study is being conducted to assess the safety and tolerability of 1 PEGPH20 in combination with CIS and GEM PEGCISGEM and 2 PEGPH20 in combination with CIS GEM and atezolizumab PEGCISGEMATEZO compared with 3 cisplatin and gemcitabine CISGEM
Detailed Description:
The study will have a Run-in portion and an Expansion portion The Run-in portion will be used to evaluate the safety profile of the PEGCISGEM and PEGCISGEMATEZO treatments prior to evaluating the efficacy and safety of PEGCISGEM and PEGCISGEMATEZO treatments compared with CISGEM treatment in the Expansion portion of the study Treatment in both portions of the study will continue until death withdrawal of consent from the study disease progression or unacceptable toxicity
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