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NCT Number: NCT05998135

Repurposing Atovaquone for the Treatment of Platinum-Resistant Ovarian Cancer

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.

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Key information

Conditions

Ovarian High Grade Serous Adenocarcinoma Platinum-Resistant Ovarian Carcinoma

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Atovaquone

Drug

Given PO

Other names: 566C80, BW-566C, BW-A566C, Mepron

Biopsy

Procedure

Undergo biopsy

Other names: BIOPSY_TYPE, Bx

Computed Tomography

Procedure

Undergo CT

Other names: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized axial tomography (procedure), Computerized Tomography, CT, CT Scan, tomography

Paracentesis

Procedure

Undergo paracentesis

Primary outcomes

  1. Progression free survival (PFS)

    Time frame: From initiation of atovaquone to progression or death, assessed up to 1 year

    Will be estimated using the Kaplan-Meier method, and a 95% confidence interval for median PFS will be estimated using the Brookmeyer-Crowley approach.

Secondary outcomes

  1. Clinical benefit rate

    Time frame: At 6 months

    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.

  2. Overall survival (OS)

    Time frame: 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

    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.

  3. Incidence of adverse events

    Time frame: Up to 30 days

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Namita Khanna, MD, MSPH

CONTACT

[email protected]

404-778-3401

Sponsors and collaborators

Lead sponsor

Emory University

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Aug 18, 2023
Registry last updated
Sep 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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