Ovarian High Grade Serous AdenocarcinomaPhase 2NCT05998135
Repurposing Atovaquone for the Treatment of Platinum-Resistant Ovarian Cancer
A Phase 2 study testing Atovaquone, Biopsy and Computed Tomography in people with Ovarian High Grade Serous Adenocarcinoma and Platinum-Resistant Ovarian Carcinoma, run by Emory University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian High Grade Serous Adenocarcinoma, Platinum-Resistant Ovarian Carcinoma
- What is being tested?
- Atovaquone, Biopsy and Computed Tomography
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Nov 2023to 30 Jun 2028
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, 30322
Nina Kimball, 404-778-8145, nina.cathleen.dobbs.kimball@emory.edu
Maisey S Ratcliffe, 404-778-3449, maisey.shannon.ratcliffe@emory.edu
About this study
Official title: Phase II Clinical Trial 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.
Read the detailed description
PRIMARY OBJECTIVE:
- To determine progression free survival of twenty-eight patients with platinum-resistant ovarian cancer treated with atovaquone.
SECONDARY OBJECTIVES:
- 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.
- Being tested
- Atovaquone, Biopsy, Computed Tomography, Paracentesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtovaquoneDrug
Also called 566C80, BW-566C, BW-A566C, Mepron
Given PO
BiopsyProcedure or surgery
Also called BIOPSY_TYPE, Bx
Undergo biopsy
Computed TomographyProcedure or surgery
Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography
Undergo CT
ParacentesisProcedure or surgery
Undergo paracentesis
| Study group | Role | What they receive |
|---|---|---|
| Treatment (atovaquone) | Experimental | Patients receive atovaquone PO on study. Patients also undergo CT and biopsy or paracentesis throughout the study. Receives: Drug: Atovaquone; Procedure: Biopsy; Procedure: Computed Tomography; Procedure: Paracentesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival (PFS)
Will be estimated using the Kaplan-Meier method, and a 95% confidence interval for median PFS will be estimated using the Brookmeyer-Crowley approach.
Measured: From initiation of atovaquone to progression or death, assessed up to 1 year
Secondary outcomes (3)
Clinical benefit rate
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.
Measured: At 6 months
Overall survival (OS)
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.
Measured: 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
Incidence of adverse events
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.
Measured: Up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2023
- Study start9 Nov 2023
- Primary completion24 Mar 2027 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian High Grade Serous AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Namita Khanna, Emory University
- Investigators
- Namita Khanna, MD, MSPH, Principal investigator, Emory University Hospital/Winship Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05998135
- Sponsor's protocol ID
- STUDY00005363
- Other IDs
- NCI-2023-03479, STUDY00005363, WINSHIP5782-22, P30CA138292
- Status last verified
- Sep 2026
- First submitted
- 11 Aug 2023
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No