Repurposing Atovaquone for the Treatment of Platinum-Resistant Ovarian Cancer
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ClinicalTrials.gov Identifier: NCT05998135 |
Recruitment Status :
Recruiting
First Posted : August 18, 2023
Last Update Posted : February 20, 2024
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Ovarian High Grade Serous Adenocarcinoma Platinum-Resistant Ovarian Carcinoma | Drug: Atovaquone Procedure: Biopsy Procedure: Computed Tomography Procedure: Paracentesis | Phase 2 |
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.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 28 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Phase II Clinical Trial Repurposing Atovaquone for the Treatment of Platinum-Resistant Ovarian Cancer |
Actual Study Start Date : | November 9, 2023 |
Estimated Primary Completion Date : | June 30, 2024 |
Estimated Study Completion Date : | June 30, 2025 |
Arm | Intervention/treatment |
---|---|
Experimental: Treatment (atovaquone)
Patients receive atovaquone PO on study. Patients also undergo CT and biopsy or paracentesis throughout the study.
|
Drug: Atovaquone
Given PO
Other Names:
Procedure: Biopsy Undergo biopsy
Other Names:
Procedure: Computed Tomography Undergo CT
Other Names:
Procedure: Paracentesis Undergo paracentesis |
- Progression free survival (PFS) [ Time Frame: From initiation of atovaquone to progression or death, assessed up to 1 year ]Will be estimated using the Kaplan-Meier method, and a 95% confidence interval for median PFS will be estimated using the Brookmeyer-Crowley approach.
- Clinical benefit rate [ Time Frame: At 6 months ]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.
- Overall survival (OS) [ Time Frame: 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 ]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.
- Incidence of adverse events [ Time Frame: Up to 30 days ]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.
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05998135
Contact: Namita Khanna, MD, MSPH | 404-778-3401 | namita.khanna@emory.edu |
United States, Georgia | |
Emory University Hospital/Winship Cancer Institute | Recruiting |
Atlanta, Georgia, United States, 30322 | |
Contact: Nina Kimball 404-778-8145 nina.cathleen.dobbs.kimball@emory.edu | |
Contact: Maisey S Ratcliffe 404-778-3449 maisey.shannon.ratcliffe@emory.edu | |
Principal Investigator: Namita Khanna, MD, MSPH |
Principal Investigator: | Namita Khanna, MD, MSPH | Emory University Hospital/Winship Cancer Institute |
Responsible Party: | Namita Khanna, Principal Investigator, Emory University |
ClinicalTrials.gov Identifier: | NCT05998135 |
Other Study ID Numbers: |
STUDY00005363 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 ) |
First Posted: | August 18, 2023 Key Record Dates |
Last Update Posted: | February 20, 2024 |
Last Verified: | February 2024 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | No |
Cystadenocarcinoma, Serous Adenocarcinoma Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Cystadenocarcinoma Neoplasms, Cystic, Mucinous, and Serous |
Atovaquone Anti-Infective Agents Antimalarials Antiprotozoal Agents Antiparasitic Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |