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NCT05998135PHASE2Recruiting

Repurposing Atovaquone for the Treatment of Platinum-Resistant Ovarian Cancer

Emory University

Start Date

11/9/2023

Completion Date

6/30/2027

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.

Detailed 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.

Eligibility Criteria

Age Range: 18 years to No maximum

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

Interventions

DRUG

Atovaquone

PROCEDURE

Biopsy

PROCEDURE

Computed Tomography

PROCEDURE

Paracentesis

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Conditions

Ovarian High Grade Serous AdenocarcinomaPlatinum-Resistant Ovarian Carcinoma

Locations

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia 30322

United States