Atorvastatin ± Aspirin in Lynch Syndrome Syndrome

Plain-language summary

This study evaluated the drug Atorvastatin, alone or together with Aspirin, in people with Lynch syndrome. To join, participants had to be 18 or older with Lynch syndrome confirmed by a mutation in the MLH1, MSH2, MSH6, EPCAM, or PMS2 genes. The study was conducted in Early Phase 1 and has been completed.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Early Phase 1

Status

Completed

Sponsor

Fox Chase Cancer Center

Intervention

Atorvastatin 20mg, Atorvastatin 20mg AND Aspirin 325 mg

Start date

9/10/2018

Estimated completion

8/4/2025

Countries

United States

Related genes

Locations

• Philadelphia, United States

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

Inclusion Criteria:

* Subjects who are 18 years of age or older
* Able to read and sign an informed consent document in English
* Eligible subjects will have molecular evidence of Lynch Syndrome (mutation in MLH1, MSH2, MSH6, EPCAM or PMS2)
* History of colorectal cancer if surgically cured and \> 1 year from completion of adjuvant chemotherapy

Exclusion Criteria:

* Are \<18 years of age
* Unable to read and sign an informed consent document in English
* Have active cancer or are less than 3 years post hormonal maintenance therapy for cancer
* Have statin intolerance or contraindication for aspirin or atorvastatin use
* Are pregnant or are actively breast feeding