Repurposing Atovaquone for the Treatment of Platinum-Resistant Ovarian Cancer

Platinum-Resistant Ovarian Carcinoma Clinical Trial

Official title:

Phase II Clinical Trial Repurposing Atovaquone for the Treatment of Platinum-Resistant Ovarian Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05998135
• Other study ID #: STUDY00005363
• Secondary ID: NCI-2023-03479ST
• Status: Recruiting
• Phase: Phase 2
• Start date: November 9, 2023
• Est. completion date: June 30, 2025

Study information

• Verified date: February 2024
• Source: Emory University
• Contact: Namita Khanna, MD, MSPH
• Phone: 404-778-3401
• Email: namita.khanna[@]emory.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This phase II trial test tests how well repurposing atovaquone works in treating patients with platinum-resistant ovarian cancer. Atovaquone is used for the treatment or prevention of certain infections. Atovaquone is in a class of medications called antiprotozoal agents. It works by stopping the growth of certain types of protozoa that can cause pneumonia. Giving atovaquone may be effective in treating platinum-resistant ovarian cancer and result in improved outcomes compared to standard chemotherapy regimens.

Description:

PRIMARY OBJECTIVE:

I. To determine progression free survival of twenty-eight patients with platinum-resistant ovarian cancer treated with atovaquone.

SECONDARY OBJECTIVES:

I. To determine clinical benefit rate (complete response, partial response or stable disease) at six months.

II. To determine overall survival. III. To quantitate the on-target STAT3 inhibitory effect of atovaquone on STAT3-dependent gene transcription.

IV. To quantitate changes of the tumor immune infiltrate by inhibition of STAT3 with atovaquone.

OUTLINE:

Patients receive atovaquone orally (PO) on study. Patients also undergo computed tomography (CT) and biopsy or paracentesis throughout the study.

After completion of study treatment, patients are followed up for 30 days and then every 6 month thereafter.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 28
• Est. completion date: June 30, 2025
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with platinum-resistant, high-grade serous ovarian cancer, defined as disease progression within six months of completion of their last platinum-based chemotherapy

• Patients must maintain Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

• There will be no limitations on number of prior lines of therapy

• Trial is open to non-English speaking patients

• Trial is open to patients referred from community practice

Exclusion Criteria:

• Patients who are < 18 years old

• Patients who are pregnant or breastfeeding (due to cancer of their reproductive organs, patients enrolled in the trial are unable to conceive)

• Patients who are incarcerated

• Patients who are unable to provide consent / lack decision-making capacity

Related Conditions & MeSH terms

• Platinum-Resistant Ovarian Carcinoma

Intervention

Drug:
• Atovaquone
Given PO

Procedure:
• Biopsy
Undergo biopsy
• Computed Tomography
Undergo CT
• Paracentesis
Undergo paracentesis

Locations

Country	Name	City	State
United States	Emory University Hospital/Winship Cancer Institute	Atlanta	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
Emory University	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression free survival (PFS)	Will be estimated using the Kaplan-Meier method, and a 95% confidence interval for median PFS will be estimated using the Brookmeyer-Crowley approach.	From initiation of atovaquone to progression or death, assessed up to 1 year
Secondary	Clinical benefit rate	Clinical benefit rate is defined as complete response, partial response, and/or stable disease at six months. Clinical response will be assessed every 6 weeks for the first 24 months and every 12 weeks thereafter using Response Evaluation Criteria in Solid Tumors 1.1 criteria. Will be estimated as a proportion, with an exact 95% confidence interval estimated using the Clopper-Pearson method.	At 6 months
Secondary	Overall survival (OS)	OS will be estimated using the Kaplan-Meier method, and median survival will be calculated. A 95% confidence interval will be estimated using the Brookmeyer-Crowley approach.	From diagnosis to death from any cause, where patients who are alive will be censored at last follow-up date, assessed up to 1 year
Secondary	Incidence of adverse events	Safety will be determined according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5. Frequencies and percentages will be used to summarize safety events.	Up to 30 days