What side effects are associated with this type of intervention?

Treatments for Serous Cystadenoma similar to Auranofin and Sirolimus can cause a range of side effects. Auranofin may lead to gastrointestinal issues, skin rashes, and blood cell abnormalities. Sirolimus is associated with mouth sores, increased risk of infections, elevated lipid levels, and delayed wound healing. Patients undergoing these treatments should be monitored for these potential adverse effects.

What prior FDA approvals exist?

There are no specific FDA-approved treatments for Serous Cystadenoma that directly align with the mechanisms of action of Auranofin (a thioredoxin reductase inhibitor) and Sirolimus (an mTOR inhibitor). However, mTOR inhibitors like Sirolimus have been explored in various clinical trials for different types of tumors and cystic diseases. For Serous Cystadenoma, treatment typically involves surgical intervention rather than pharmacological approaches.

What other types of research exist?

Promising novel alternatives for treating Serous Cystadenoma in 2024 include PARP inhibitors such as Olaparib, Rucaparib, and Niraparib, which have shown efficacy in ovarian cancer, particularly in patients with BRCA mutations. Additionally, angiogenesis inhibitors like Bevacizumab and Cediranib are also promising options, as they target the vascular endothelial growth factor (VEGF) pathway, which is crucial in ovarian cancer progression.

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Gold Compound

Auranofin + Sirolimus for Ovarian Cancer

Phase 2

Waitlist Available

Led By Aminah Jatoi, M.D.

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year 4 months

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include suppression of the immune system leading to an increased risk of infections, possible changes in blood cell counts, as well as any individual reactions related to auranofin or sirolimus such as digestive issues or skin reactions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year 4 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year 4 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year 4 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of Participants With a Confirmed Tumor Response (Partial Response [PR] or Complete Response [CR] at Least 4 Weeks Apart)

Secondary study objectives

Number of Participants Experiencing at Least One Grade 3 or Worse Adverse Event (AE)

Number of Participants With a Confirmed Tumor Response (PR or CR at Least 4 Weeks Apart) in the Subset of Participants That Have Over-expression of Protein Kinase C (PKC) Iota

Overall Survival (OS)

+1 more

Side effects data

From 2021 Phase 2 trial • 93 Patients • NCT02736968

24%

Nausea

18%

Asthenia

18%

Rash

12%

Diarrhoea

Pain

Pyrexia

Abscess Rupture

Respiratory Tract Infection

Arthralgia

Dysgeusia

Headache

Pruritus

Vertigo

Abdominal Pain

Furuncle

100%

80%

60%

40%

20%

Study treatment Arm

Asymptomatic E. Histolytica- Placebo

Asymptomatic Giardia- Auranofin

Asymptomatic Giardia- Placebo

Symptomatic Giardia- Auranofin

Symptomatic Giardia- Placebo

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (auranofin, sirolimus)Experimental Treatment3 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Auranofin

2016

Completed Phase 2

~180

Sirolimus

2013

Completed Phase 4

~2750

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Auranofin, a thioredoxin reductase inhibitor, increases oxidative stress and induces apoptosis in cancer cells by inhibiting the thioredoxin reductase enzyme. Sirolimus, an mTOR inhibitor, blocks the mTOR pathway, which is essential for cell growth and proliferation, thereby reducing tumor growth. These mechanisms are significant for Serous Cystadenoma patients as they target critical survival and growth pathways in cancer cells, potentially improving treatment efficacy.

Retracted: Anticancer Activity of Metformin, an Antidiabetic Drug, Against Ovarian Cancer Cells Involves Inhibition of Cysteine-Rich 61 (Cyr61)/Akt/Mammalian Target of Rapamycin (mTOR) Signaling Pathway.Comparative oncology approach to drug repurposing in osteosarcoma.