Trials Sponsors Conditions Drugs Pricing

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 40mgDrug

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

Also known as: Zocor

Simvastatin

Eligibility Criteria

Age18 Years+

Sexfemale

Healthy VolunteersNo

Age GroupsAdult (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.

Sponsors & Collaborators

Marc Goodman
Otherlead

Study Sites (1)

Cedars Sinai Medical Center

Los Angeles, California, 90048, United States

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

Simvastatin

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital Diseases

Study Officials

Bobbie Jo Rimel, MD
Cedars-Sinai Medical Center
PRINCIPAL INVESTIGATOR

Enrollment

18 participants (actual enrollment reported by the registry).

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

Actual (reported)

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (1)

Simvastatin

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Intervention Hierarchy (Ancestors)

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (1)

Simvastatin

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Intervention Hierarchy (Ancestors)

Data Sharing

Source record

Locations