Auranofin and Sirolimus in Treating Participants With Ovarian Cancer
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|ClinicalTrials.gov Identifier: NCT03456700|
Recruitment Status : Recruiting
First Posted : March 7, 2018
Last Update Posted : April 3, 2018
|Condition or disease||Intervention/treatment||Phase|
|Ovarian Serous Tumor Recurrent Ovarian Carcinoma||Drug: Auranofin Other: Laboratory Biomarker Analysis Drug: Sirolimus||Phase 2|
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.
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.
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.
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||48 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Trial to Evaluate the Efficacy of Auranofin and Sirolimus in Serous Ovarian Cancer Patients With Recurrent Disease|
|Actual Study Start Date :||March 30, 2018|
|Estimated Primary Completion Date :||March 15, 2023|
|Estimated Study Completion Date :||March 15, 2023|
Experimental: Treatment (auranofin, sirolimus)
Participants receive auranofin PO QD and sirolimus PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unaccepted toxicity.
Other Name: Ridaura
Other: Laboratory Biomarker Analysis
- Proportion of patients with a confirmed tumor response (partial response [PR] or complete response [CR] at least 4 weeks apart) [ Time Frame: Up to 3 years ]Ninety-five percent confidence intervals for the true success proportion will be calculated according to the exact binomial method.
- Incidence of adverse event (AE) [ Time Frame: Up to 3 years ]The maximum grade for each type of AE will be recorded for each patient, and frequency tables will be reviewed to determine AE patterns.
- Overall survival (OS) [ Time Frame: Time from registration to death from any cause, assessed up to 3 years ]OS will be estimated using the method of Kaplan-Meier.
- Progression-free survival (PFS) [ Time Frame: Time from registration to the first of either disease progression or death from any cause, assessed up to 3 years ]PFS will be estimated using the method of Kaplan-Meier.
- Proportion of patients with a confirmed tumor response (PR or CR at least 4 weeks apart) in the subset of patients that have overexpression of PKCiota [ Time Frame: Up to 3 years ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03456700
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Contact: Clincial Trials Referral Office 855-776-0015|
|Principal Investigator: Aminah Jatoi|
|Principal Investigator:||Aminah Jatoi||Mayo Clinic|