Auranofin + Sirolimus for Ovarian Cancer

Age: 18+

Sex: Female

Trial Phase: Phase 2

Sponsor: Mayo Clinic

Must not be taking: St. John's wort, CYP3A4 inhibitors

Disqualifiers: Platinum-sensitive, Brain metastasis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 6

Duration: 28 days per cycle, repeated

22 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing auranofin and sirolimus in patients with metastatic serous ovarian cancer. These drugs might help control the cancer and improve blood cell counts. Auranofin is being tested for its feasibility in treating ovarian cancer patients without symptoms.

Research Team

Aminah Jatoi, M.D.

Principal Investigator

Mayo Clinic

Eligibility Criteria

This trial is for people with ovarian cancer, including serous cystadenoma, who have measurable disease and a life expectancy of at least 12 weeks. They should be relatively healthy (ECOG score 0 or 1) and have certain blood counts and chemistries within specific ranges. Those with controlled brain metastasis, unresolved effects from past treatments, or sensitive to platinum-based therapies are excluded.

Inclusion Criteria

Eastern Cooperative Oncology Group (ECOG) performance score of 0 or 1

Ovarian, Fallopian Tube or Primary Peritoneal cancer of serous histology

Incurable cancer

Exclusion Criteria

Failure to recover from acute, reversible effects of prior therapy regardless of interval since last treatment

NOTE: Patients can have peripheral (sensory) neuropathy

History of hypertriglyceridemia or hypercholesterolemia and currently on medication(s)

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive auranofin and sirolimus orally once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

28 days per cycle, repeated

Follow-up

Participants are monitored for safety and effectiveness after treatment completion every 6 months for 3 years.

3 years

Every 6 months

Treatment Details

Interventions

• Auranofin
• Sirolimus

Trial Overview The effectiveness of auranofin and sirolimus in treating ovarian cancer is being tested. These drugs aim to suppress the immune system which might help increase blood cell count in participants with this condition.

Participant Groups

Group I: Treatment (auranofin, sirolimus) Experimental Treatment 3 Interventions

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.

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+