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Auranofin and Sirolimus in Treating Participants With Ovarian Cancer

Recurrent Ovarian Carcinoma Clinical Trial

Official title:
Phase II Trial to Evaluate the Efficacy of Auranofin and Sirolimus in Serous Ovarian Cancer Patients With Recurrent Disease

Clinical Trial Summary

This phase II trial studies how well auranofin and sirolimus work in treating participants with ovarian cancer. Immunosuppressive therapy, such as auranofin and sirolimus, is used to decrease the body?s immune response and may increase blood cell count.

Clinical Trial Description

PRIMARY OBJECTIVES: I. To estimate the overall tumor response rate (ORR, that is, complete response [CR] + partial response [PR]) of the combination of auranofin and sirolimus in the setting of metastatic serous ovarian cancer across all patients. SECONDARY OBJECTIVES: I. To estimate the overall tumor response rate (ORR, that is, complete response [CR] + partial response [PR]) of the combination of auranofin and sirolimus in the setting of metastatic serous ovarian cancer within patients that have overexpression of PKCiota. II. To estimate progression-free survival, overall survival, and adverse events from the combination of auranofin and sirolimus. CORRELATIVE OBJECTIVES: I. To explore whether PKCiota-relevant biomarkers in serous ovarian cancer tumors are associated with treatment response patterns, such as ORR, progression free survival, and overall survival. OUTLINE: Participants receive auranofin orally (PO) once daily (QD) and sirolimus PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unaccepted toxicity. After completion of study treatment, participants are followed up every 6 months for 3 years. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03456700
Study type Interventional
Source Mayo Clinic
Contact
Status Active, not recruiting
Phase Phase 2
Start date March 30, 2018
Completion date June 30, 2024
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