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NCT04911816 · ClinicalTrials.gov registry record · Phase 1
Neoadjuvant mFOLFIRINOX With Perioperative Oral Hydroxychloroquine in Resectable Pancreatic Adenocarcinoma
A Phase 1 study of Adenocarcinoma of the Pancreas, sponsored by West Virginia University.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 40
- Enrollment target
- 1
- Study location
NCT04911816: Recruiting Phase 1 study of Adenocarcinoma of the Pancreas, sponsored by West Virginia University.
NCT04911816 is a Phase 1 study of Adenocarcinoma of the Pancreas that is actively recruiting participants, run by West Virginia University. The registered enrollment target is 40 participants, below the 86-participant average among 10 other Adenocarcinoma of the Pancreas trials with a reported enrollment target (53% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04911816, a Phase 1 study of Adenocarcinoma of the Pancreas, is actively recruiting participants, sponsored by West Virginia University.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 40 participants
- Enrollment target
- 1
- Study location
Study Summary
This will be a phase I/II trial examining the safety and tolerability of pre-operative mFOLFIRINOX in combination with peri-operative oral hydroxychloroquine (FHQ) in the treatment of subjects with adenocarcinoma of the pancreas. Subjects will be staged prior to protocol entry by contrast-enhanced helical abdominal CT scan done using a pancreas mass protocol or EUS. Eligible subjects with biopsy-proven, resectable pancreatic adenocarcinoma without evidence of venous or arterial involvement on CT scan receive HCQ orally in combination with mFOLFIRINOX prior to surgery. Hydroxychloroquine will begin with the first dose of mFOLFIRINOX and continue for 2 weeks post-operatively. Three to six weeks after the last dose of mFOLFIRINOX, patients will undergo surgical exploration and pancreatectomy if technically feasible and all toxicities have resolved. Pathologic specimens will undergo detailed histopathologic and immunohistochemical evaluations with particular attention to the six surgical margins of resection: the bile duct margin (for Whipple specimens), the margin of pancreatic transection, the retroperitoneal margin, the proximal and distal duodenal margins (for Whipple specimens), and the portal vein margin along the pancreatic head (for Whipple specimens) or medial pancreas (for distal pancreatectomies). Tissue specimens will be stored at -80C for future correlative studies of autophagy and tumor response to protocol therapy. Ten to fourteen weeks following completion of successful surgical removal of their tumor, subjects will undergo repeat staging studies per standard of care. Subjects will pursue standard of care adjuvant therapy options at the discretion of their physician.
Primary Outcome
Maximum tolerated dose (MTD) for FHQ which is defined as the highest dose level in which the investigators have treated 6 patients with at most 1 experiencing dose limiting toxicities (DLT). A maximum of 18 patients (3x6) will be accrued for dose finding.
Conditions Studied
Interventions
- DRUG Hydroxychloroquine sulfate
Study Locations (1)
West Virginia
- West Virginia University Cancer Institute Mary Babb Randolph Cancer Center - Morgantown
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2021-07-16 |
| Est. Completion | 2030-06 |
| Phase | Phase 1 |
What NCT04911816 shows while recruiting
NCT04911816 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 86-participant average among 10 other Adenocarcinoma of the Pancreas trials with a reported enrollment target (53% lower).
The record links to 1 condition, with Adenocarcinoma of the Pancreas appearing as the primary indexed condition, and to 1 intervention - of which Hydroxychloroquine sulfate is the first listed.
NCT04911816 reports a single indexed study location in West Virginia.
Frequently Asked Questions
What is clinical trial NCT04911816 about?
NCT04911816 is a clinical study titled "Neoadjuvant mFOLFIRINOX With Perioperative Oral Hydroxychloroquine in Resectable Pancreatic Adenocarcinoma". This will be a phase I/II trial examining the safety and tolerability of pre-operative mFOLFIRINOX in combination with peri-operative oral hydroxychloroquine (FHQ) in the treatment of subjects with adenocarcinoma of the pancreas. Subjects will be staged prior to protocol entry by contrast-enhanced h...
What is the current status of trial NCT04911816?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 40 participants. The study started on 2021-07-16. Estimated completion is 2030-06.
What conditions does trial NCT04911816 study?
This clinical trial studies the following conditions: Adenocarcinoma of the Pancreas.
What interventions are being tested in trial NCT04911816?
The interventions under investigation include: Hydroxychloroquine sulfate (DRUG).
Who is sponsoring clinical trial NCT04911816?
This trial is sponsored by West Virginia University, which has 122 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04911816 being conducted?
This trial has 1 study location across West Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT04911816's enrollment target sits among peer trials
40 4th of 10 higher than 6 of 10 other Adenocarcinoma of the Pancreas trials
participants (enrollment target), bucketed by value
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