Ignite Creation Date:
2025-12-24 @ 6:40 PM
Ignite Modification Date:
2026-02-24 @ 3:14 PM
Study NCT ID:
NCT02237157
Status:
COMPLETED
Last Update Posted:
2021-05-07
First Post:
2014-09-08
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Dose Escalation Safety Study of Locally-Delivered Gemcitabine in Pancreatic Cancer
Sponsor:
RenovoRx
Organization:
Study Overview
Official Title:
A Dose Escalation Safety Study of Locally-Delivered (Intra-Arterial) Gemcitabine in Unresectable Adenocarcinoma of the Pancreas
Status:
COMPLETED
Status Verified Date:
2021-04
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:
A dose escalation, safety study of local (intra-arterially) delivered gemcitabine to the pancreas using the RenovoCath R120 catheter to determine the maximum tolerated dose.
Detailed Description:
Patients diagnosed with unresectable pancreatic cancer who may or may not have had prior chemotherapy or radiation therapy may be eligible to enroll in this dose escalation study to determine the maximum tolerated dose of gemcitabine to be delivered locally to the pancreatic tumors using the RenovoCath R120 catheter. Patients enrolled may receive up to 8 catheterizations for delivering gemcitabine directly to the pancreatic tumors starting at a reduced dose( 1/4 of standard i.v. gemcitabine dose), then every two doses, increase the dose by 25% if there are no toxicities up to a maximum dose of 1000 mg/m2. There are four cycles, with two doses per cycle. Imaging studies will be conducted as well as assessment for standard, myelosuppresive and gastric toxicities will be assessed. Pain will also be measured throughout the study.
Study Oversight
Has Oversight DMC:
True
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?: