NCT03456700

Auranofin and Sirolimus in Treating Participants With Ovarian Cancer

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Ovarian Serous Tumor
• Recurrent Ovarian Carcinoma

Interventions

Type	Name	Description
DRUG	Auranofin	Given PO
OTHER	Laboratory Biomarker Analysis	Correlative studies
DRUG	Sirolimus	Given PO

Timeline

• Start date: 2018-03-30
• Primary completion: 2019-07-31
• Completion: 2019-07-31
• First posted: 2018-03-07
• Last updated: 2025-05-08
• Results posted: 2020-07-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study