← Back to Search

Hormone Therapy

Tamoxifen for Pancreatic Cyst (MCN_Tam Trial)

Phase 1

Waitlist Available

Led By Kelsey Klute, MD

Research Sponsored by University of Nebraska

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months (approximately 360 days)

Awards & highlights

MCN_Tam Trial Summary

"This trial will test if tamoxifen can prevent the growth of precancerous cells in the pancreas in patients who are not having immediate surgery. About 15 patients will take tamoxifen daily

Who is the study for?

This trial is for individuals with certain types of non-cancerous pancreatic cysts known as mucinous cystic neoplasms (MCNs) who are not scheduled for immediate surgery to remove these cysts. Specific eligibility details are not provided.Check my eligibility

What is being tested?

The study is testing the effectiveness of a medication called Tamoxifen, taken orally at a dose of 20mg daily, in preventing cancer in patients with MCN. Up to 15 participants will be involved and the treatment duration is up to 24 weeks.See study design

What are the potential side effects?

While specific side effects for this trial aren't listed, common side effects of Tamoxifen can include hot flashes, vaginal discharge or bleeding, mood swings, fatigue, and an increased risk of blood clots.

MCN_Tam Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months (approximately 360 days)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months (approximately 360 days)

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months (approximately 360 days) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Feasibility, by adherence rate

Feasibility, by retention rate

Secondary outcome measures

Objective response rate (ORR) of pancreatic MCN

Side effects data

From 2013 Phase 1 trial • 89 Patients • NCT01393990

33%

Leukopenia

33%

Anaemia

33%

Lymphopenia

33%

Hypoxia

33%

Vomiting

33%

Chest discomfort

33%

Insomnia

33%

Neutropenia

33%

Nausea

33%

Chest pain

33%

Chills

33%

Decreased appetite

33%

Dizziness

33%

Cough

33%

Oropharyngeal pain

33%

Dry skin

33%

Pyrexia

33%

Stomatitis

33%

Palpitations

33%

Diarrhoea

33%

Dysphagia

33%

Tremor

33%

Respiratory tract congestion

33%

Bronchitis

33%

Fatigue

33%

Seasonal allergy

100%

80%

60%

40%

20%

Study treatment Arm

Part A: 160 mg LY2228820 Capsules

Part D: 200 mg LY2228820 Tablets

Part D: 300 mg LY2228820 Tablets

Part A: 160 mg LY2228820 Bridge

Part A: 200 mg LY2228820 Tablets

Part A: 120 mg LY2228820 Capsules

Part A: 300 mg LY2228820 Tablets

Part A: 90 mg LY2228820 Capsules

Part A: 420 mg LY2228820 Tablets

Part C: 300 mg LY2228820 Tablets

Part A: 200 mg LY2228820 Capsules

Part A: 65 mg LY2228820 Capsules

Part A: 10 mg LY2228820 Capsules

Part A: 20 mg LY2228820 Capsules

Part A: 160 mg LY2228820 Tablets

Part A: 40 mg LY2228820 Capsules

Part B: 420 mg LY2228820 Tablets

Part A: 560 mg LY2228820 Tablets

MCN_Tam Trial Design

1Treatment groups

Experimental Treatment

Group I: TamoxifenExperimental Treatment1 Intervention

Tamoxifen 20mg by mouth daily for up to 6 months

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of NebraskaLead Sponsor

539 Previous Clinical Trials

1,144,719 Total Patients Enrolled

1 Trials studying Pancreatic Cyst

1,250 Patients Enrolled for Pancreatic Cyst

Kelsey Klute, MDPrincipal InvestigatorUniversity of Nebraska

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are individuals currently able to enroll in this research study?

"As per information on clinicaltrials.gov, the current trial is not actively seeking new participants. The trial was initially posted on May 1st, 2024 and last revised on March 13th, 2024. Although this specific trial is no longer recruiting, there are currently 2598 other trials in search of eligible participants."

Answered by AI

Has Tamoxifen received official approval from the FDA?

"According to our assessment at Power, Tamoxifen's safety rating is 1 due to the preliminary nature of this Phase 1 trial with restricted evidence backing its safety and effectiveness."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2024. "Chemoprevention With Tamoxifen in Pre-Invasive Pancreas Mucinous Cystic Neoplasms Not Undergoing Immediate Resection". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06320990.

All > Appendix Cancer