Oral Minoxidil for the Treatment of Recurrent Platinum Resistant Epithelial Ovarian Cancer
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|ClinicalTrials.gov Identifier: NCT05272462|
Recruitment Status : Recruiting
First Posted : March 9, 2022
Last Update Posted : June 29, 2022
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|Condition or disease||Intervention/treatment||Phase|
|Ovarian Cancer||Drug: Minoxidil||Phase 2|
Minoxidil is approved by the Food and Drug Administration (FDA) for treatment of hypertension. In previous studies, the sulfonylurea receptor (SUR) subunit controls the selectivity of the pharmacological response to drugs that either inhibit or stimulate the Kir6/SUR channel. Oral minoxidil acts as an activator of the Kir6/SUR2 channel upon selective binding to sulfonylurea receptor 2 (SUR2). Activation of the Kir6.2 potassium channel by minoxidil leads to potassium outflow and calcium entry which produces a cytoplasmic electrical charge that is more negative. This in turn creates an attractive force for calcium to enter the cell. Increased intracellular calcium disrupts mechanisms of cell division by arresting the cell cycle in G2/M phase and this is associated with alteration of the oxidative state, disruption of the mitochondria and activation of the caspase-3-independent cell death pathway.
Evaluation of arrest of tumor growth was evaluated in a previous study. This was done in vitro as well as in vivo by establishing a xenograft model from a Kir6.2/SUR2 positive high grade serous ovarian cancer cell line. In the mice treated with minoxidil, five of the 6 mice had no evidence of measurable disease at necropsy. In contrast, the untreated mice were found to have carcinomatosis and ascites in all 6 mice, demonstrating tumor reduction with minoxidil treatment.
While recurrent ovarian cancer can be treated with a multitude of drugs, the response rates are limited. Treatment options can also be limited secondary to myelosuppression as a result of patients being heavily pretreated. Minoxidil appears to have the advantage of not causing severe myelosuppression which can limit treatment options for patients. Laboratory results provide promising evidence that minoxidil could be used for the treatment of recurrent ovarian cancer.
This study plans to conduct a single center phase II study to evaluate the efficacy and safety of oral minoxidil in the treatment of platinum resistant ovarian cancer. The primary goal is to assess whether treatment with minoxidil will reduce tumor burden in patients with recurrent ovarian cancer and have a minimal toxicity profile.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||34 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||This is a non-randomized prospective single-site trial of minoxidil for patients living with recurrent platinum resistant ovarian cancer.|
|Masking:||None (Open Label)|
|Masking Description:||This study is an open-label Phase II trial|
|Official Title:||A Phase II Trial of Oral Minoxidil for the Treatment of Recurrent Platinum Resistant Epithelial Ovarian Cancer|
|Actual Study Start Date :||December 13, 2021|
|Estimated Primary Completion Date :||December 31, 2023|
|Estimated Study Completion Date :||December 31, 2023|
Participants in this arm will be treated with minoxidil. This treatment will be given daily by mouth.
Minoxidil is an antihypertensive vasodilator medication commonly used for the treatment of high blood pressure and pattern hair loss.
Other Name: Rogaine
- Overall response rate (ORR) [ Time Frame: At the end of Cycle 2 (each cycle is 28 days) ]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)
- Progression-free survival (PFS) [ Time Frame: Up to 24 months ]PFS is defined as the time from receipt of minoxidil to the first documented progression of disease or death due to any cause, whichever occurred first
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|Ages Eligible for Study:||18 Years to 90 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||Female|
|Gender Based Eligibility:||Yes|
|Accepts Healthy Volunteers:||No|
- 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.
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05272462
|Contact: Margaret Liotta, DOfirstname.lastname@example.org|
|Contact: Mary Beth Bartolotta, RNemail@example.com|
|United States, Illinois|
|Loyola University Medical Center||Recruiting|
|Maywood, Illinois, United States, 60153|
|Contact: Margaret Liotta, DO 708-216-5423 firstname.lastname@example.org|
|Contact: Mary Beth Bartolotta, RN 708-327-3222 email@example.com|
|Principal Investigator: Margaret Liotta, DO|
|Principal Investigator:||Margaret Liotta, DO||Loyola University|
|Responsible Party:||Margaret Liotta, Associate Professor, Loyola University|
|Other Study ID Numbers:||
|First Posted:||March 9, 2022 Key Record Dates|
|Last Update Posted:||June 29, 2022|
|Last Verified:||June 2022|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Plan Description:||There is no plan to share individual participant data with other researchers.|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
|Product Manufactured in and Exported from the U.S.:||Yes|
Epithelial Ovarian Cancer
Carcinoma, Ovarian Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Genital Diseases, Female
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Genital Neoplasms, Female
Endocrine System Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type