Ignite Creation Date:
2024-05-06 @ 9:09 AM
Last Modification Date:
2024-10-26 @ 12:10 PM
Study NCT ID:
NCT02910882
Status:
TERMINATED
Last Update Posted:
2019-04-11
First Post:
2016-08-12
Brief Title:
PEGPH20 Plus Gemcitabine With Radiotherapy in Patients With Localized Unresectable Pancreatic Cancer
Sponsor:
Scripps Health
Organization:
Scripps Health
Study Overview
Official Title:
A Phase II Study Combining PEGPH20 With Concurrent Gemcitabine and Radiotherapy in Patients With Localized Unresectable Pancreatic Adenocarcinoma
Status:
TERMINATED
Status Verified Date:
2019-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Safety
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HALO-IST
Brief Summary:
This is a single arm phase II trial assessing the potential activity of combination PEGPH20 plus Gemcitabine with radiotherapy in ten patients with localized unresectable pancreatic adenocarcinoma
Detailed Description:
This is a pilot trial evaluating the safety and potential efficacy of PEGylated Recombinant Human Hyaluronidase PEGPH20 plus concurrent Gemcitabine and radiotherapy Recognizing that PEGPH20 has not been previously delivered with radiotherapy but is unlikely to contribute to increased toxicities this trial will have an abbreviated sequential dose escalation schema for the first three patients PEGPH20 will be given twice per week for the first 28 days and then weekly for another 2 weeks during radiotherapy Gemcitabine will be delivered weekly at the first day of radiotherapy and continued weekly per published literature Patients will remain on study for three months The duration of active treatment with PEGPH20 and Gemcitabine plus radiotherapy will continue for 5-6 weeks Efficacy outcome will occur 6-8 weeks after the completion of radiotherapy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None