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Statin Therapy for Ovarian Cancer

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.
Must not have
Uncontrolled intercurrent illness
Prior or current use of any statin medication
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline until 12 months
Awards & highlights
No Placebo-Only Group

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.
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.
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
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My ovarian cancer has returned but responds to platinum treatment.
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I am not allergic or unable to take carboplatin, liposomal doxorubicin, or simvastatin.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have any unmanaged ongoing illnesses.
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I have taken statin medication before or am currently taking it.
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I am currently taking medications that interact with statins.
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I have been treated with doxorubicin or liposomal doxorubicin before.
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I have a long-term muscle disease.
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I have had cancer before, but it wasn't ovarian cancer or a non-melanoma skin cancer.
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I have an active HIV infection.
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I have active liver disease or cirrhosis.

Timeline

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Completion of the simvastatin intervention with at least 85% compliance
Secondary study objectives
Progression-free survival
Response by CA125

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
~320

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
~0 spots leftby Jan 2025
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