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Trial Title:
Repurposing Atovaquone for the Treatment of Platinum-Resistant Ovarian Cancer
NCT ID:
NCT05998135
Condition:
Ovarian High Grade Serous Adenocarcinoma
Platinum-Resistant Ovarian Carcinoma
Conditions: Official terms:
Cystadenocarcinoma, Serous
Atovaquone
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Atovaquone
Description:
Given PO
Arm group label:
Treatment (atovaquone)
Other name:
566C80
Other name:
BW-566C
Other name:
BW-A566C
Other name:
Mepron
Intervention type:
Procedure
Intervention name:
Biopsy
Description:
Undergo biopsy
Arm group label:
Treatment (atovaquone)
Other name:
BIOPSY_TYPE
Other name:
Bx
Intervention type:
Procedure
Intervention name:
Computed Tomography
Description:
Undergo CT
Arm group label:
Treatment (atovaquone)
Other name:
CAT
Other name:
CAT Scan
Other name:
Computed Axial Tomography
Other name:
Computerized Axial Tomography
Other name:
Computerized axial tomography (procedure)
Other name:
Computerized Tomography
Other name:
CT
Other name:
CT Scan
Other name:
tomography
Intervention type:
Procedure
Intervention name:
Paracentesis
Description:
Undergo paracentesis
Arm group label:
Treatment (atovaquone)
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.
Criteria for 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
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Emory University Hospital/Winship Cancer Institute
Address:
City:
Atlanta
Zip:
30322
Country:
United States
Status:
Recruiting
Contact:
Last name:
Nina Kimball
Phone:
404-778-8145
Email:
nina.cathleen.dobbs.kimball@emory.edu
Contact backup:
Last name:
Maisey S Ratcliffe
Phone:
404-778-3449
Email:
maisey.shannon.ratcliffe@emory.edu
Investigator:
Last name:
Namita Khanna, MD, MSPH
Email:
Principal Investigator
Start date:
November 9, 2023
Completion date:
June 30, 2026
Lead sponsor:
Agency:
Emory University
Agency class:
Other
Collaborator:
Agency:
National Cancer Institute (NCI)
Agency class:
NIH
Source:
Emory University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05998135
