Repurposing Atovaquone for the Treatment of Platinum-Resistant Ovarian Cancer

NCT05998135 | Recruiting Phase 2 DMC FDA Drug

• 4 other identifiers: STUDY00005363NCI-2023-03479WINSHIP5782-22P30CA138292
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Ovarian High Grade Serous Adenocarcinoma; Platinum-Resistant Ovarian Carcinoma

Outcome Measures

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.

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

Secondary Outcomes (3)

• Clinical benefit rate

  At 6 months

• Overall survival (OS)

  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

  Up to 30 days

Study Arms (1)

Treatment (atovaquone)

EXPERIMENTAL

Patients receive atovaquone PO on study. Patients also undergo CT and biopsy or paracentesis throughout the study.

Drug: Atovaquone; Procedure: Biopsy; Procedure: Computed Tomography; Procedure: Paracentesis

Interventions

Atovaquone DRUG

Given PO

Also known as: 566C80, BW-566C, BW-A566C, Mepron

Treatment (atovaquone)

Biopsy PROCEDURE

Undergo biopsy

Also known as: BIOPSY_TYPE, Bx

Treatment (atovaquone)

Computed Tomography PROCEDURE

Undergo CT

Also known as: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized axial tomography (procedure), Computerized Tomography, CT, CT Scan, tomography

Treatment (atovaquone)

Paracentesis PROCEDURE

Undergo paracentesis

Treatment (atovaquone)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Emory University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, 30322, United States

RECRUITING

MeSH Terms

Interventions

Atovaquone; Biopsy; Paracentesis

Intervention Hierarchy (Ancestors)

Naphthoquinones; Quinones; Organic Chemicals; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques; Drainage; Therapeutics; Punctures

Study Officials

• Namita Khanna, MD, MSPH

  Emory University Hospital/Winship Cancer Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Namita Khanna, MD, MSPH

CONTACT

404-778-3401; namita.khanna@emory.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 11, 2023
• First Posted: August 18, 2023
• Study Start: November 9, 2023
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: September 11, 2025

Record last verified: 2025-09

Locations

US (1)