Chemoprevention With Tamoxifen in Pre-Invasive Pancreas Mucinous Cystic Neoplasms Not Undergoing Immediate Resection

Trial Title: Chemoprevention With Tamoxifen in Pre-Invasive Pancreas Mucinous Cystic Neoplasms Not Undergoing Immediate Resection

NCT ID: NCT06320990

Condition: Pancreatic Cyst
Pancreatic Mucinous Cystic Neoplasm

Conditions: Official terms:
Neoplasms
Pancreatic Cyst
Neoplasms, Cystic, Mucinous, and Serous
Tamoxifen

Study type: Interventional

Study phase: Phase 1

Overall status: Not yet recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Prevention

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Tamoxifen 20mg
Description: Tamoxifen is a nonsteroidal antiestrogen for oral administration.
Arm group label: Tamoxifen

Other name: Soltamox

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.

Criteria for eligibility:
Criteria:
Inclusion Criteria: - Age ≥ 19 years - Clinically diagnosed pre-invasive pancreatic mucinous cystic neoplasm (MCN), measurable by cross-sectional imaging - Surgical resection of the lesion is not planned due to cyst features, patient factors or patient preference - Females of reproductive potential and males with partners of reproductive potential must agree to employ two methods contraception throughout the study and for up to 3 months following treatment. Non-child-bearing potential is defined as age 45 years or older and no menses for greater than or equal to 12 months or any age with surgical removal of the uterus and/or both ovaries. - Estimated glomerular filtration rate (eGFR) > 30mL/min/1.73m2 - Willing and able to provide informed consent to and abide by the protocol Exclusion Criteria: - Presence of invasive pancreatic adenocarcinoma or high-grade dysplasia - Presence of a solid component or mural nodule, main pancreatic duct dilation or abrupt caliber change, obstructive jaundice, lymphadenopathy - Current or prior use of tamoxifen or another estrogen antagonist including, but not limited to, clomifene, raloxifene, fulvestrant, anastrazole; subjects who have previously used an estrogen antagonist are eligible provided the last use was at least 5 years prior to enrollment. - Current or planned use of hormonal treatments including estrogen, progesterone, androgens, hormone replacement therapy or other types of hormonal contraceptives including implants and depot injections; levonorgestrel-releasing intrauterine device (IUD) is permitted. - Contraindications to tamoxifen including: - Pregnancy or nursing - Known allergy or hypersensitivity to tamoxifen - Cataracts which affect visual acuity (ie. symptomatic) - Retinopathy which affects visual acuity (ie. symptomatic) - Current warfarin use - History of deep vein thrombosis or pulmonary embolism or other condition which, in the discretion of the treating physician, may significantly increase the individual's risk of venous thromboembolism - History of stroke - Known endometrial hyperplasia or personal history of endometrial carcinoma, uterine sarcoma and uterine carcinosarcoma - History of intestinal disease or major gastric surgery likely to alter absorption of tamoxifen or inability to swallow oral medications - Uncontrolled illness including but not limited to ongoing or active infection requiring IV antibiotics, symptomatic congestive heart failure, unstable angina or uncontrolled cardiac arrhythmias, or other conditions which might jeopardize or preclude the ability of the patient to take tamoxifen or the safety of follow-up visits, scans and procedures - Elective surgery planned for the study period - Participation in another clinical study with an investigational product during the last 28 days - Any subject, in the opinion of the treating physician, who will not be able to tolerate treatment, or the patient is unsuitable to participate in the study and the patient is unlikely to comply with study procedures, restrictions and requirements

Gender: All

Minimum age: 19 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: University of Nebraska Medical Center

Address:
City: Omaha
Zip: 68198
Country: United States

Contact:
Last name: Christina Hoy, DNP
Email: choy@nebraskamed.com

Investigator:
Last name: Kelsey Klute, MD
Email: Principal Investigator

Start date: November 2024

Completion date: May 2027

Lead sponsor:
Agency: University of Nebraska
Agency class: Other

Source: University of Nebraska

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06320990