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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

Study Summary

This trial is testing how well a combination of two drugs, auranofin and sirolimus, work in treating ovarian cancer.

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.Check my eligibility

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.See study design

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

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%

Rash

18%

Asthenia

12%

Diarrhoea

Pruritus

Pyrexia

Arthralgia

Abscess Rupture

Respiratory Tract Infection

Dysgeusia

Headache

Pain

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

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor

3,206 Previous Clinical Trials

3,767,061 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,657 Previous Clinical Trials

40,933,645 Total Patients Enrolled

Aminah Jatoi, M.D.Principal InvestigatorMayo Clinic

9 Previous Clinical Trials

377 Total Patients Enrolled

Media Library

Auranofin (Gold Compound) Clinical Trial Eligibility Overview. Trial Name: NCT03456700 — Phase 2

Serous Cystadenoma Research Study Groups: Treatment (auranofin, sirolimus)

Serous Cystadenoma Clinical Trial 2023: Auranofin Highlights & Side Effects. Trial Name: NCT03456700 — Phase 2

Auranofin (Gold Compound) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03456700 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What other explorations of Auranofin have been noted in the literature?

"Currently, Auranofin is being investigated in 125 active studies with 13 trials reaching Phase 3. Cincinnati Ohio has numerous sites studying this drug but there are 1,074 other medical centres conducting clinical research on it."

Answered by AI

Is this experiment actively seeking participants?

"This clinical trial has ceased looking for participants. It was first posted on March 30th 2018 and last updated on the 22nd of March 2022. For those searching for other studies, there are currently 64 trials recruiting patients with serous ovarian cancer and 125 active Auranofin medical experiments in need of recruits."

Answered by AI

What is the scope of enrollment for this research project?

"This research is not taking on new participants at the present time. It was initially posted to clinicaltrials.gov in March 2018 and last updated in March 2022. For those looking for other trials, there are 64 studies recruiting patients with serous ovarian tumors and 125 enrolling Auranofin users."

Answered by AI

What is the risk associated with taking Auranofin therapeutically?

"Our team at Power rated the safety of Auranofin as a 2, since there has been some research into its security but not yet any reports on its efficacy."

Answered by AI

What is Auranofin routinely recommended for?

"Auranofin is commonly employed to reject organ transplants and alleviate the symptoms of liver disease. It has also been used with success in addressing rheumatoid arthritis and kidney maladies."

Answered by AI

Recent research and studies

ChemMedChemJournal

Conception and Evaluation of Fluorescent Phosphine‐gold Complexes: From Synthesis to in Vivo Investigations

Rousselle, Benjamin, Aurélie Massot, Malorie Privat, Lucile Dondaine, Audrey Trommenschlager, Florence Bouyer, Jérôme Bayardon, et al.. 2022. “Conception and Evaluation of Fluorescent Phosphine‐gold Complexes: From Synthesis to in Vivo Investigations”. Chemmedchem. Wiley. doi:10.1002/cmdc.202100773.

clinicaltrials.govStudy

Auranofin and Sirolimus in Treating Participants With Ovarian Cancer

2018. "Auranofin and Sirolimus in Treating Participants With Ovarian Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03456700.

All > Recurrent Ovarian Cancer