Repurposing Atovaquone for the Treatment of Platinum-Resistant Ovarian Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18+
SponsorEmory University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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 design
Design model
Single group
Treatments tested in this trial
Atovaquone
DrugGiven PO
Biopsy
Procedure/SurgeryUndergo biopsy
Computed Tomography
Procedure/SurgeryUndergo CT
Paracentesis
Procedure/SurgeryUndergo paracentesis
Treatment groups
28 Participants
are divided into 1 treatment groupGroup A: Treatment (atovaquone)Experimental treatment 4 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
From initiation of atovaquone to progression or death, assessed up to 1 yearSecondary outcomes
1
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.
Time frame
At 6 months2
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.
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 year3
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.
Time frame
Up to 30 daysSponsors and contacts
Click on the lead sponsor to view all of their trials.
Emory University
Lead sponsor
National Cancer Institute (NCI)
Collaborator
Source ClinicalTrials.gov