NCT05272462

Brief Summary

The primary purpose of this study is to determine the response rate of patients with recurrent platinum resistant ovarian cancer when treated with oral minoxidil. Secondary objectives include estimating the time to disease progression while on minoxidil and to describe the toxicities of minoxidil when used for patients with recurrent platinum resistant ovarian cancer. An exploratory objective is to evaluate if efficacy of minoxidil is improved in patients that have the Kir6/SUR complex versus those that do not.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
34

participants targeted

Target at P25-P50 for phase_2 ovarian-cancer

Timeline
Completed

Started Dec 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 13, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 9, 2022

Completed
28 days until next milestone

First Posted

Study publicly available on registry

March 9, 2022

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

October 5, 2023

Status Verified

October 1, 2023

Enrollment Period

3.1 years

First QC Date

February 9, 2022

Last Update Submit

October 3, 2023

Conditions

Ovarian Cancer

Keywords

Ovarian CancerPlatinum ResistantEpithelial Ovarian Cancer

Outcome Measures

Primary Outcomes (1)

  • Overall response rate (ORR)

    The ORR is defined as the percentage of participants who experience a complete response (CR), partial response (PR), or stable disease (SD) as defined by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI-CTCAE v5.0)

    At the end of Cycle 2 (each cycle is 28 days)

Secondary Outcomes (1)

  • Progression-free survival (PFS)

    Up to 24 months

Study Arms (1)

Treatment

EXPERIMENTAL

Participants in this arm will be treated with minoxidil. This treatment will be given daily by mouth.

Drug: Minoxidil

Interventions

MinoxidilDRUG

Minoxidil is an antihypertensive vasodilator medication commonly used for the treatment of high blood pressure and pattern hair loss.

Also known as: Rogaine
Treatment

Eligibility Criteria

Age18 Years - 90 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participants must have recurrent platinum resistant ovarian cancer. Histologic documentation of the recurrence is not required.
  • Participants must have platinum resistant disease defined as recurrence less than 6 months after initial platinum based treatment.
  • Participants must be greater than or equal to 18 years of age.
  • Participants must have an Eastern Cooperative Group (ECOG) Performance Status (PS) less than or equal to 2.
  • Participants must be able to take oral medications.

You may not qualify if:

  • Participants must not have had chemotherapy or radiotherapy within 4 weeks
  • Participants must not be receiving any other investigational agents.
  • Participants must not have brain metastases
  • Participants must not have allergic reactions to minoxidil
  • Participants must not have congestive heart failure
  • Participants must not have history of cardiac disease
  • Participants must not have uncontrolled hypertension
  • Participants must not be on dialysis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Loyola University Medical Center

Maywood, Illinois, 60153, United States

RECRUITING

MeSH Terms

Conditions

Ovarian NeoplasmsCarcinoma, Ovarian Epithelial

Interventions

Minoxidil

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal DisordersCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

PiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrimidines

Study Officials

  • Margaret Liotta, DO

    Loyola University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Margaret Liotta, DO

CONTACT

708-216-5423mliotta@lumc.edu

Mary Beth Bartolotta, RN

CONTACT

708-327-3222mbartolotta@luc.edu

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Masking Details
This study is an open-label Phase II trial
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: This is a non-randomized prospective single-site trial of minoxidil for patients living with recurrent platinum resistant ovarian cancer.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 9, 2022

First Posted

March 9, 2022

Study Start

December 13, 2021

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

October 5, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

There is no plan to share individual participant data with other researchers.

Locations

US(1)