A Pre-Op Window Study Evaluating Anti-Proliferative Effects of Atorvastatin on the Endometrium

Completed · Early Phase 1

Conditions studied: Endometrial Cancer

In brief

This is a preoperative window, phase 0 study of short-term atorvastatin treatment in obese women who are to undergo surgical staging for endometrial cancer.

Key facts

Study ID

NCT02767362

Run by

UNC Lineberger Comprehensive Cancer Center

People needed

24

Starts

2015-11-01

Expected to finish

2019-09-26

Last updated by the study team

2020-07-07

Who can join

Age: 18 and older, up to 75. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Be between the ages of 18-75 years old
• Have a confirmed diagnosis of type I endometrial cancer (endometrioid) based on pre-operative endometrial biopsy or dilation and curettage (D\&C)
• Have a BMI >30
• Have no contraindication to short-term atorvastatin therapy
• Have a serum creatinine ≤ 1.0 mg/dL
• Have normal serum transaminase values (AST and ALT)
• Need to be able to undergo atorvastatin treatment for a minimum of 2 weeks but no more than a maximum of 4 weeks prior to surgical staging

You may not qualify if…

• Are currently taking a statin or have taken a statin in the past 6 months or have a history of an allergic reaction or intolerance at any time to a statin
• Have a history of liver or renal dysfunction
• Have a history of alcoholism
• Are pregnant
• Are currently taking any hormonal therapy or have been on hormonal therapy in the past 4 weeks
• Are taking a drug that may significantly interact or influence the metabolism of atorvastatin
• Concomitant cyclosporine, gemfibrozil, telaprevir, or tipranavir/ritonavir use
• History of stroke or transient ischemic attack in the preceding 6 months

Where it is running

• University of North Carolina at Chapel Hill Lineberger Comprehensive Cancer Center — Chapel Hill, North Carolina, United States

Full record on ClinicalTrials.gov

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