Recruiting
Phase 2

Minoxidil

Sponsor:

Loyola University

Code:

NCT05272462

Conditions

Ovarian Cancer

Eligibility Criteria

Sex: Female

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Minoxidil

Study Details

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.

Conditions

Ovarian Cancer

Study ID

NCT05272462

Start date

Dec 13, 2021

Status verified date

Oct, 2023

Completion date

Dec 31, 2024

Anticipated

Primary completion date

Dec 31, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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

Study Design

Enrollment

34 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Treatment

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

Interventions

Minoxidil

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

Primary outcome measure

  • Overall response rate (ORR) [ Time Frame: At the end of Cycle 2 (each cycle is 28 days) ]

Central Contacts and Locations

Central contacts

Margaret Liotta, DO

708-216-5423mliotta@lumc.edu

Mary Beth Bartolotta, RN

708-327-3222mbartolotta@luc.edu

Locations

Loyola University Medical Center

Recruiting

Maywood, Illinois, United States, 60153

Contacts

Margaret Liotta, DO

708-216-5423mliotta@lumc.edu

Mary Beth Bartolotta, RN

708-327-3222mbartolotta@luc.edu

Principal Investigator:

Margaret Liotta, DO

More Information

Sponsor

Loyola University

Last update posted

Oct 5, 2023

Last verified

Oct, 2023

Keywords

  • Ovarian Cancer
  • Platinum Resistant
  • Epithelial Ovarian Cancer

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Loyola University on 2023-10-05.