Clinical trial · Interventional
A Pre-Op Window Study Evaluating Anti-Proliferative Effects of Atorvastatin on the Endometrium
Evaluating the Anti-Proliferative Effects of Atorvastatin on the Endometrium of Endometrial Cancer Patients: A Pre-Operative Window Study
NCT02767362CI-TRIAL-00045821completedEarly Phase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Endometrial Cancer | Malignant Endometrial Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Atorvastatin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Single Arm
- description
- Patients will undergo atorvastatin treatment for a minimum of 2 weeks but no more than a maximum of 4 weeks prior to surgery. At the time of hysterectomy and surgical staging, women will undergo repeat endometrial biopsy in the operating room under general anesthesia.
- interventionNames
- Drug: Atorvastatin
Primary outcomes (1)
- measure
- Absolute difference score
- timeFrame
- Two Years
- description
- Measurement of the change in tumor proliferation as measured by Ki67 immunohistochemical staining after 2-4 weeks of treatment with atorvastatin. For visual comparisons of pre- and post-treatment measures, informative plots will be generated. For statistical comparisons of pre- and post-treatment measures absolute difference scores will be created. An absolute difference score is the subtraction of a post-treatment measurement from a pre-treatment measurement. The nonparametric Wilcoxon signed-rank tests will be used to examine the significance of the absolute difference scores for each measure of interest.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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
References
Publications (0)
Data not yet available
No reference posted for this study.