Status:
ACTIVE_NOT_RECRUITING
Statin Therapy to Reduce Progression in Women With Platinum Sensitive Ovarian Cancer
Lead Sponsor:
Marc Goodman
Conditions:
Recurrent Ovarian Cancer
Platinum-sensitive Ovarian Cancer
Eligibility:
FEMALE
18+ years
Phase:
EARLY_PHASE1
Brief Summary
This is a single arm pilot trial to evaluate the feasibility of using a simvastatin intervention, and to evaluate its effects on cancer progression, among 20 patients with platinum-sensitive ovarian c...
Detailed Description
This is a pilot study of statin therapy to examine the feasibility of simvastatin use to reduce disease progression in 20 patients with platinum-sensitive ovarian cancer at Cedars-Sinai Medical Center...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- Prior or current use of any statin medication
- Current systemic use of medications known to interact with statins
- Current use of any other investigational agents
- Liver disease, active cirrhosis
- Uncontrolled intercurrent illness
- History of chronic myopathy
- Prior cancer other than ovarian cancer or non-melanomatous skin cancers
- Known active infection with HIV
- Current excessive alcohol consumption (average alcohol consumption of more than 5 drinks per day)
- Prior exposure to doxorubicin or liposomal doxorubicin
- Hemoglobin A1C \>8.0%
Key Trial Info
Start Date :
January 25 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2026
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT04457089
Start Date
January 25 2021
End Date
January 1 2026
Last Update
September 9 2025
Active Locations (1)
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1
Cedars Sinai Medical Center
Los Angeles, California, United States, 90048