Repurposing Atovaquone for the Treatment of Platinum-Resistant Ovarian Cancer

Emory University

Status and phase

Enrolling

Phase 2

Conditions

Ovarian High Grade Serous Adenocarcinoma

Platinum-Resistant Ovarian Carcinoma

Treatments

Drug: Atovaquone

Procedure: Biopsy

Procedure: Computed Tomography

Procedure: Paracentesis

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT05998135

P30CA138292 (U.S. NIH Grant/Contract)

NCI-2023-03479 (Registry Identifier)

STUDY00005363 (Other Identifier)

WINSHIP5782-22 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

28 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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