Repurposing Atovaquone for the Treatment of Platinum-Resistant Ovarian Cancer

NCT ID: NCT05998135

Last Updated: 2025-09-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-09

Study Completion Date

2027-06-30

Brief Summary

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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

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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.

Conditions

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Ovarian High Grade Serous Adenocarcinoma Platinum-Resistant Ovarian Carcinoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment (atovaquone)

Patients receive atovaquone PO on study. Patients also undergo CT and biopsy or paracentesis throughout the study.

Group Type EXPERIMENTAL

Atovaquone

Intervention Type DRUG

Given PO

Biopsy

Intervention Type PROCEDURE

Undergo biopsy

Computed Tomography

Intervention Type PROCEDURE

Undergo CT

Paracentesis

Intervention Type PROCEDURE

Undergo paracentesis

Interventions

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Atovaquone

Given PO

Intervention Type DRUG

Biopsy

Undergo biopsy

Intervention Type PROCEDURE

Computed Tomography

Undergo CT

Intervention Type PROCEDURE

Paracentesis

Undergo paracentesis

Intervention Type PROCEDURE

Other Intervention Names

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566C80 BW-566C BW-A566C Mepron BIOPSY_TYPE Bx CAT CAT Scan Computed Axial Tomography Computerized Axial Tomography Computerized axial tomography (procedure) Computerized Tomography CT CT Scan tomography

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Emory University

OTHER

Sponsor Role lead

Responsible Party

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Namita Khanna

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Namita Khanna, MD, MSPH

Role: PRINCIPAL_INVESTIGATOR

Emory University Hospital/Winship Cancer Institute

Locations

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Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Namita Khanna, MD, MSPH

Role: CONTACT

404-778-3401

Facility Contacts

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Nina Kimball

Role: primary

404-778-8145

Maisey S Ratcliffe

Role: backup

404-778-3449

Other Identifiers

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NCI-2023-03479

Identifier Type: REGISTRY

Identifier Source: secondary_id

STUDY00005363

Identifier Type: OTHER

Identifier Source: secondary_id

WINSHIP5782-22

Identifier Type: OTHER

Identifier Source: secondary_id

P30CA138292

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00005363

Identifier Type: -

Identifier Source: org_study_id

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