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CompletedNCT04457089Updated Feb 4, 2026

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

An Early Phase 1 interventional study of Simvastatin 40mg in Recurrent Ovarian Cancer and Platinum-sensitive Ovarian Cancer, sponsored by Marc Goodman. Completed at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-04.

Sponsored by Marc Goodman · Early Phase 1, Interventional, and Treatment

From the registry’s dates

  • Primary completion was Nov 2024, 1 year 11 months ago, and no results have been posted to the registry.
Phase
Early Phase 1
Study type
Interventional
Enrollment
18
Allocation
Not applicable
Ages
18 Years and older
Sex
Female
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Study 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.

Read the 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. This study will focus on patients with recurrent platinum sensitive ovarian cancer to increase the likelihood that this population will experience recurrent disease during the 6-month intervention and follow-up. In addition, this population of patients has a narrow range of standard of care carboplatin doublet combinations that are prescribed, enabling the investigators to create a more homogenous study population. Given their high risk of developing recurrent disease, women with platinum sensitive ovarian cancer, have the potential to derive the maximum benefit from an intervention that could delay disease progression and enhance survival.

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Conditions studied

  • Recurrent Ovarian Cancer
  • Platinum-sensitive Ovarian Cancer

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Keywords

  • simvastatin
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In context

Ovarian Neoplasms

2,695 studies on the registry are indexed under Ovarian Neoplasms; 727 are open to participants now.

This study's enrollment of 18 is below the median of 60 across 2,030 interventional studies indexed under Ovarian Neoplasms.

Browse Ovarian Neoplasms studies →

Lead sponsor

Marc Goodman is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • 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 criteria

Exclusion Criteria:

  • 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%
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Study design

Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
18 participants (actual)

Study arms

  • Experimental
    Simvastatin

    Drug: Simvastatin 40mg

Interventions

  • DrugSimvastatin 40mg

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

    Also known as: Zocor

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What researchers measure

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.

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

Secondary outcomes

  1. Response by CA125

    Change in serum level of CA125

    Time frame: From baseline until 12 months

  2. Progression-free survival

    Duration until disease progression or death

    Time frame: From baseline until 12 months

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Study locations

1 site
  • Cedars Sinai Medical Center
    Los Angeles, California 90048, United States
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 4, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04457089
Lead sponsor
Marc Goodman
Responsible party
Marc Goodman (Oncologist, Cedars-Sinai Medical Center) — Sponsor-investigator
First posted
Jul 7, 2020
Start date
Jan 25, 2021
Primary completion
Nov 1, 2024
Completion
May 12, 2025
Last update
Feb 4, 2026

Study contacts

Bobbie Jo Rimel, MD
principal investigator · Cedars-Sinai Medical Center

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.

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