Ignite Creation Date:
2025-12-25 @ 2:14 AM
Ignite Modification Date:
2026-03-06 @ 6:19 PM
Study NCT ID:
NCT02080260
Status:
COMPLETED
Last Update Posted:
2022-04-21
First Post:
2014-03-03
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of Regorafenib in Advanced Pancreatic Cancer Patients
Sponsor:
Wake Forest University Health Sciences
Organization:
Study Overview
Official Title:
A Pilot Study Testing Single-Agent Regorafenib in Advanced Previously-Treated Adenocarcinoma of the Pancreas
Status:
COMPLETED
Status Verified Date:
2019-07
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 tests regorafenib as a single agent in the treatment of metastatic pancreatic cancer patients who have progressed after prior chemotherapy with gemcitabine. The prognosis for these patients is particularly grim, no other standard treatment options exist, and novel approaches are desperately needed.
Detailed Description:
This is a single arm, single stage Phase II study designed to evaluate progression free survival (PFS) in patients with metastatic pancreatic cancer who have failed at least one prior line of therapy and treatment with gemcitabine. This study is open at the Levine Cancer Institute (LCI). A total of 32 patients will be enrolled over a two years. Following informed consent and eligibility check, all patients will start oral regorafenib therapy (120 mg daily for 3 weeks on / 1 week off; 28 day cycle) with a built-in dose escalation to 160mg after the first cycle as tolerated, and will continue therapy until progression or patient withdrawal. Patients will undergo radiological staging after the first two cycles of regorafenib therapy. Patients with progressive disease will be removed from the study. Patients who have at least stable disease will continue regorafenib therapy, at the Investigator's discretion, and will be radiologically restaged bimonthly.
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?: