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Repurposing Atovaquone for the Treatment of Platinum-Resistant Ovarian Cancer

Status
Active
Cancer Type
Ovarian Cancer
Trial Phase
Phase II
Eligibility
18 Years and older, Female
Study Type
Treatment
NCT ID
NCT05998135
Protocol IDs
WINSHIP5782-22 (primary)
NCI-2023-03479
STUDY00005363
Study Sponsor
Emory University Hospital/Winship Cancer Institute

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.

Objectives

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) once daily (QD) on study. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. 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

  1. Patients with platinum-resistant, high-grade serous ovarian cancer, defined as disease progression within six months of completion of their last platinum-based chemotherapy
  2. Patients must maintain Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  3. There will be no limitations on number of prior lines of therapy
  4. Trial is open to non-English speaking patients
  5. Trial is open to patients referred from community practice

Treatment Sites in Georgia

Winship Cancer Institute of Emory University


1365 Clifton Road NE
Building C
Atlanta, GA 30322
winshipcancer.emory.edu

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.