← Back to Search

Statin Therapy for Ovarian Cancer

Q: Is this pioneering clinical trial the first of its kind?

Since 2005, Simvastatin 40mg has been the subject of numerous drug trials. The first trial was conducted by Merck Sharp &#x26; Dohme LLC in 2005 and included 80 participants. Subsequently, it received its Phase 4 approval and today there are 37 active clinical trials being carried out across 31 nations encompassing 239 cities.

Q: To what medical issues is Simvastatin 40mg usually prescribed as a remedy?

Simvastatin 40mg is commonly used as a remedy for high <a href="https://www.withpower.com/clinical-trials/cholesterol">cholesterol</a> levels, but it can also be beneficial for <a href="https://www.withpower.com/clinical-trials/diabetes">diabetes</a> mellitus, <a href="https://www.withpower.com/clinical-trials/cardiovascular">cardiovascular</a> event prevention and hypercholesterolemia.

Q: What is the current sample size for this research trial?

Affirmative. Data hosted on clinicaltrials.gov supports that this medical study, which was initially announced on January 25th 2021, is actively recruiting patients. Approximately 20 individuals need to be admitted from 1 site.

Q: Have any additional experiments been conducted utilizing Simvastatin 40mg?

At present, there are 37 active trials for Simvastatin 40mg, 7 of which being in the final phase. These studies primarily take place at Pontyclun, Wales; however, they can be found across 480 other locations worldwide.

Q: Is this research experiment currently recruiting participants?

Affirmative. The details published on clinicaltrials.gov demonstrate that this medical study is enlisting participants at present. It was made public on January 25th 2021 and recently updated in April of 2022.

Phase < 1

Recruiting

Research Sponsored by Bobbie Jo Rimel, MD

Eligibility Criteria Checklist

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

Must have

Recurrent platinum sensitive ovarian cancer, all histologies (serous, endometrioid, mucinous, clear cell). Platinum sensitivity defined as ≥ 6 months since last platinum treatment.

No contraindication to carboplatin and/or liposomal doxorubicin or simvastatin.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from baseline until 12 months

Awards & highlights

Study Summary

This trial is testing whether simvastatin can help treat ovarian cancer. 20 patients will be given the drug and monitored for effects on their cancer.

Who is the study for?

This trial is for women with recurrent ovarian cancer that responds to platinum-based chemotherapy, provided they haven't used statins or drugs that interact with them, have no liver disease or uncontrolled illnesses, and don't consume excessive alcohol.Check my eligibility

What is being tested?

The study tests the use of Simvastatin 40mg in combination with carboplatin and liposomal doxorubicin on 20 patients at Cedars-Sinai Medical Center to see if it slows down cancer progression in those with platinum-sensitive ovarian cancer.See study design

What are the potential side effects?

Simvastatin may cause muscle pain, weakness, liver problems, digestive issues, blood sugar changes. When combined with chemotherapy drugs like carboplatin and liposomal doxorubicin, side effects can include nausea, fatigue, risk of infection.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My ovarian cancer has returned but responds to platinum treatment.

Select...

I am not allergic or unable to take carboplatin, liposomal doxorubicin, or simvastatin.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from baseline until 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from baseline until 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline until 12 months for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Completion of the simvastatin intervention with at least 85% compliance

Secondary outcome measures

Progression-free survival

Response by CA125

Trial Design

1Treatment groups

Experimental Treatment

Group I: SimvastatinExperimental Treatment1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Simvastatin 40mg

2018

Completed Phase 2

~160

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Bobbie Jo Rimel, MDLead Sponsor

Media Library

Simvastatin 40mg Clinical Trial Eligibility Overview. Trial Name: NCT04457089 — Phase < 1

Ovarian Cancer Research Study Groups: Simvastatin

Ovarian Cancer Clinical Trial 2023: Simvastatin 40mg Highlights & Side Effects. Trial Name: NCT04457089 — Phase < 1

Simvastatin 40mg 2023 Treatment Timeline for Medical Study. Trial Name: NCT04457089 — Phase < 1

Frequently Asked Questions

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

Is this pioneering clinical trial the first of its kind?

"Since 2005, Simvastatin 40mg has been the subject of numerous drug trials. The first trial was conducted by Merck Sharp & Dohme LLC in 2005 and included 80 participants. Subsequently, it received its Phase 4 approval and today there are 37 active clinical trials being carried out across 31 nations encompassing 239 cities."

Answered by AI

To what medical issues is Simvastatin 40mg usually prescribed as a remedy?

"Simvastatin 40mg is commonly used as a remedy for high cholesterol levels, but it can also be beneficial for diabetes mellitus, cardiovascular event prevention and hypercholesterolemia."

Answered by AI

What is the current sample size for this research trial?

"Affirmative. Data hosted on clinicaltrials.gov supports that this medical study, which was initially announced on January 25th 2021, is actively recruiting patients. Approximately 20 individuals need to be admitted from 1 site."

Answered by AI

Have any additional experiments been conducted utilizing Simvastatin 40mg?

"At present, there are 37 active trials for Simvastatin 40mg, 7 of which being in the final phase. These studies primarily take place at Pontyclun, Wales; however, they can be found across 480 other locations worldwide."

Answered by AI

Is this research experiment currently recruiting participants?

"Affirmative. The details published on clinicaltrials.gov demonstrate that this medical study is enlisting participants at present. It was made public on January 25th 2021 and recently updated in April of 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Statin Therapy to Reduce Progression in Women With Platinum Sensitive Ovarian Cancer

Bobbie Jo Rimel, MD 2021. "Statin Therapy to Reduce Progression in Women With Platinum Sensitive Ovarian Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04457089.

All > Penicillin Allergy > Recurrent Ovarian Cancer