Clinical trial NCT05998135: Repurposing Atovaquone for the Treatment of Platinum-Resistant Ovarian Cancer
Official title: Phase II Clinical Trial Repurposing Atovaquone for the Treatment of Platinum-Resistant Ovarian Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Ovarian High Grade Serous Adenocarcinoma
Platinum-Resistant Ovarian Carcinoma
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2023-08-18
Enrollment: 28
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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. 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: 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

Primary outcomes:
measure: Progression free survival (PFS)
timeFrame: From initiation of atovaquone to progression or death, assessed up to 1 year
Secondary outcomes:
measure: Clinical benefit rate
timeFrame: At 6 months
measure: Overall survival (OS)
timeFrame: 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
measure: Incidence of adverse events
timeFrame: Up to 30 days
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University Hospital/Winship Cancer Institute
state: Georgia
Study officials:
affiliation: Emory University Hospital/Winship Cancer Institute
name: Namita Khanna, MD, MSPH
role: PRINCIPAL_INVESTIGATOR
References: