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

NCT04457089 | Completed Early Phase 1 DMC FDA Drug

• 1 other identifier: IIT2020-03-Rimel-STOV
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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 cancer, treated with carboplatin and liposomal doxorubicin at Cedars-Sinai Medical Center.

Conditions

Recurrent Ovarian Cancer; Platinum-sensitive Ovarian Cancer

Keywords

simvastatin

Outcome Measures

Primary Outcomes (1)

• Completion of the simvastatin intervention with at least 85% compliance

  Percentage of patients who complete the simvastatin intervention with at least 85% compliance during Carboplatin and Doxil chemotherapy.

  From Cycle 1 Day 1 until Cycle 6 Day 28 (each cycle is 28 days)

Secondary Outcomes (2)

• Response by CA125

  From baseline until 12 months

• Progression-free survival

  From baseline until 12 months

Study Arms (1)

Simvastatin

EXPERIMENTAL

Drug: Simvastatin 40mg

Interventions

Simvastatin 40mg DRUG

Simvastatin 40mg by mouth nightly for approximately 6 months during treatment with carboplatin and liposomal doxorubicin

Also known as: Zocor

Simvastatin

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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%

Sponsors & Collaborators

• Marc Goodman: lead

Study Sites (1)

Cedars Sinai Medical Center

Los Angeles, California, 90048, United States

Location

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

Simvastatin

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Lovastatin; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Officials

• Bobbie Jo Rimel, MD

  Cedars-Sinai Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Oncologist

Study Record Dates

• First Submitted: June 25, 2020
• First Posted: July 7, 2020
• Study Start: January 25, 2021
• Primary Completion: November 1, 2024
• Study Completion: May 12, 2025
• Last Updated: February 4, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)