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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2023-03479 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| STUDY00005363 | Other Identifier | Emory University | |
| WINSHIP5782-22 | Other Identifier | Emory University | |
| P30CA138292 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment (atovaquone) | Experimental | Patients receive atovaquone PO on study. Patients also undergo CT and biopsy or paracentesis throughout the study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atovaquone | Drug | Given PO |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical benefit rate | Clinical benefit rate is defined as complete response, partial response, and/or stable disease at six months. Clinical response will be assessed every 6 weeks for the first 24 months and every 12 weeks thereafter using Response Evaluation Criteria in Solid Tumors 1.1 criteria. Will be estimated as a proportion, with an exact 95% confidence interval estimated using the Clopper-Pearson method. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Namita Khanna, MD, MSPH | Contact | 404-778-3401 | namita.khanna@emory.edu |
| Name | Affiliation | Role |
|---|---|---|
| Namita Khanna, MD, MSPH | Emory University Hospital/Winship Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emory University Hospital/Winship Cancer Institute | Recruiting | Atlanta | Georgia | 30322 | United States |
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| ID | Term |
|---|---|
| D053626 | Atovaquone |
| D001706 | Biopsy |
| D019152 | Paracentesis |
| ID | Term |
|---|---|
| D009285 | Naphthoquinones |
| D011809 | Quinones |
| D009930 | Organic Chemicals |
| D009281 | Naphthalenes |
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| Biopsy | Procedure | Undergo biopsy |
|
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| Computed Tomography | Procedure | Undergo CT |
|
|
| Paracentesis | Procedure | Undergo paracentesis |
|
| At 6 months |
| Overall survival (OS) | OS will be estimated using the Kaplan-Meier method, and median survival will be calculated. A 95% confidence interval will be estimated using the Brookmeyer-Crowley approach. | 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 | Safety will be determined according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5. Frequencies and percentages will be used to summarize safety events. | Up to 30 days |
| D011084 |
| Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D003581 | Cytodiagnosis |
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D013048 | Specimen Handling |
| D003949 | Diagnostic Techniques, Surgical |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
| D004322 | Drainage |
| D013812 | Therapeutics |
| D011677 | Punctures |