Ignite Creation Date:
2025-12-24 @ 10:14 PM
Ignite Modification Date:
2025-12-25 @ 7:48 PM
Study NCT ID:
NCT05998135
Status:
RECRUITING
Last Update Posted:
2025-09-11
First Post:
2023-08-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Repurposing Atovaquone for the Treatment of Platinum-Resistant Ovarian Cancer
Sponsor:
Emory University
Organization:
Study Overview
Official Title:
Phase II Clinical Trial Repurposing Atovaquone for the Treatment of Platinum-Resistant Ovarian Cancer
Status:
RECRUITING
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2023-03479 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View | |
| STUDY00005363 | OTHER | Emory University | View | |
| WINSHIP5782-22 | OTHER | Emory University | View | |
| P30CA138292 | NIH | None | https://reporter.nih.gov/quic… | View |