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Repurposing Atovaquone for the Treatment of Platinum-Resistant Ovarian Cancer
NCT05998135 · Emory University
In plain English
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Official title
Phase II Clinical Trial Repurposing Atovaquone for the Treatment of Platinum-Resistant Ovarian Cancer
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.
Eligibility criteria
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
Study design
Enrollment target: 28 participants
Allocation: na
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2023-11-09
Estimated completion: 2027-06-30
Last updated: 2025-09-11
Interventions
Drug: AtovaquoneProcedure: BiopsyProcedure: Computed TomographyProcedure: Paracentesis
Primary outcomes
- • Progression free survival (PFS) (From initiation of atovaquone to progression or death, assessed up to 1 year)
Sponsor
Emory University · other
With: National Cancer Institute (NCI)
Contacts & investigators
ContactNamita Khanna, MD, MSPH · contact · namita.khanna@emory.edu · 404-778-3401
InvestigatorNamita Khanna, MD, MSPH · principal_investigator, Emory University Hospital/Winship Cancer Institute
All locations (1)
Emory University Hospital/Winship Cancer InstituteRecruiting
Atlanta, Georgia, United States