Ignite Creation Date:
2024-05-06 @ 8:18 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06320990
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-10
First Post:
2024-03-13
Brief Title:
Chemoprevention With Tamoxifen in Pre-Invasive Pancreas Mucinous Cystic Neoplasms Not Undergoing Immediate Resection
Sponsor:
University of Nebraska
Organization:
University of Nebraska
Study Overview
Official Title:
A Pilot Study of Chemoprevention With Tamoxifen in Patients With Pre-Invasive Pancreas Mucinous Cystic Neoplasms Who Will Not Undergo Immediate Resection
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
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:
MCN_Tam
Brief Summary:
This is an open-label pilot study of tamoxifen as chemoprevention in patients with pancreatic mucinous cystic neoplasms MCN who will not undergo immediate resection Up to 15 participants will be enrolled and take tamoxifen 20mg by mouth daily for up to 24 weeks
Detailed Description:
This is an open-label pilot study of tamoxifen as chemoprevention in patients with pancreatic mucinous cystic neoplasms MCN who will not undergo immediate resection Up to 15 participants will be enrolled and take tamoxifen 20mg by mouth daily for up to 24 weeks The primary endpoints are feasibility of tamoxifen as chemoprevention in participants with pancreatic MCN and objective response rate as assessed by magnetic resonance imaging MRI This study is intended to inform the design of a subsequent trial formally powered to detect the benefit of tamoxifen in treating pancreatic MCN
The clinical features of pancreatic MCN support the influence of sex hormones in the pathogenesis of the disease Anti-hormonal therapy may therefore constitute an effective approach to treatment of MCN and chemoprevention of pancreatic adenocarcinoma Preliminary analyses from preclinical studies suggest that tamoxifen inhibits proliferation and apoptosis in MCN epithelial cells and fibroblasts Investigators hypothesize that in humans treatment with tamoxifen will lead to cyst regression or stabilization and may spare or delay the need for resection
The clinical features of pancreatic MCN support the influence of sex hormones in the pathogenesis of the disease Anti-hormonal therapy may therefore constitute an effective approach to treatment of MCN and chemoprevention of pancreatic adenocarcinoma Preliminary analyses from preclinical studies suggest that tamoxifen inhibits proliferation and apoptosis in MCN epithelial cells and fibroblasts Investigators hypothesize that in humans treatment with tamoxifen will lead to cyst regression or stabilization and may spare or delay the need for resection
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?:
False
Is an FDA AA801 Violation?:
None