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Ovarian Serous TumorPhase 2NCT03456700

Auranofin and Sirolimus in Treating Participants With Ovarian Cancer

A Phase 2 study testing Auranofin, Laboratory Biomarker Analysis and Sirolimus in people with Ovarian Serous Tumor and Recurrent Ovarian Carcinoma, run by Mayo Clinic at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Auranofin, Laboratory Biomarker Analysis and Sirolimus
Could I receive a placebo?
No, everyone receives an active treatment
How many people
22 participants
Where
1 siteUnited States
Study dates
30 Mar 2018to 31 Jul 2019
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Eastern Cooperative Oncology Group (ECOG) performance score of 0 or 1
  • Ovarian, Fallopian Tube or Primary Peritoneal cancer of serous histology
  • Incurable cancer
  • Willingness to provide paraffin-embedded tissue blocks of ovarian cancer
  • Measurable disease
  • Obtained =< 14 days prior to registration: Absolute neutrophil count (ANC) >= 1500 uL
Show all 15Show fewer
  • Obtained =< 14 days prior to registration: Platelet (PLT) >= 100,000 uL
  • Obtained =< 14 days prior to registration: Hemoglobin (Hgb) >= 9 g/dL
  • Obtained =< 14 days prior to registration: Total bilirubin =< 1.5 x upper limit of normal (ULN) or direct bilirubin =< ULN
  • Obtained =< 14 days prior to registration: Serum glutamic-oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) and serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) =< 3 x ULN or SGOT (AST) and SGPT (ALT) =< 5 x ULN is acceptable if liver has tumor involvement
  • Obtained =< 14 days prior to registration: Creatinine =< 1.5 x ULN
  • Obtained =< 14 days prior to registration: Fasting serum glucose =< 1.5 x ULN
  • Obtained =< 14 days prior to registration: Total cholesterol =< 1.5 x ULN
  • Obtained =< 14 days prior to registration: Triglycerides =< 1.5 x ULN
  • Life expectancy >= 12 weeks

Who cannot join

  • Platinum-sensitive disease (exceptions allowed: patient has had a hypersensitivity reaction to platinum or the treating oncologist thinks that further platinum therapy is not in the patient?s best interest)
  • Morbidities or concurrent major illness (for example, bowel obstruction or a second active malignancy) that, in the opinion of the treating healthcare provider, would make participation in the trial problematic
  • Leptomeningeal disease or uncontrolled brain metastasis
  • 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)
  • Use of St. John?s wort =< 7 days prior to registration
  • Unable to discontinue use of a strong CYP3A4 inhibitor

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Mayo Clinic

    Rochester, Minnesota, 55905

Other trials in United States

About this study

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

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.

Read the detailed description

PRIMARY OBJECTIVES:

  1. 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:

  1. 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:

  1. 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.

Being tested
Auranofin, Laboratory Biomarker Analysis, Sirolimus
Medical subject headings
Ovarian Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AuranofinDrug

    Also called Ridaura

    Given PO

  • Laboratory Biomarker AnalysisOther

    Correlative studies

  • SirolimusDrug

    Also called AY 22989, RAPA, Rapamune, Rapamycin

    Given PO

Study groups in NCT03456700
Study groupRoleWhat they receive
Treatment (auranofin, sirolimus)ExperimentalParticipants 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.
Receives: Drug: Auranofin; Other: Laboratory Biomarker Analysis; Drug: Sirolimus

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    The outcome measure is the number of participants with a confirmed tumor response (partial response [PR] or complete response [CR] at least 4 weeks apart). PR and CR are defined using RECIST 1.1 criteria. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. CR: Disappearance of all target and non-target lesions and normalisation of tumour marker level. Any pathological lymph nodes must have reduction in short axis to <10 mm.

    Measured: 1 year 4 months

Secondary outcomes (4)

  1. 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

    The outcome measure is the number of participants with a confirmed tumor response (partial response [PR] or complete response [CR] at least 4 weeks apart) in the subset of participants that have overexpression of PKC iota. PR and CR are defined using RECIST 1.1 criteria. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. CR: Disappearance of all target and non-target lesions and normalisation of tumour marker level. Any pathological lymph nodes must have reduction in short axis to <10 mm.

    Measured: 1 year 4 months

  2. Progression-free Survival (PFS)

    Progression-free survival (PFS) is defined as the time from registration to the first of either disease progression or death from any cause. Patients who receive the study drug, but then never return for an evaluation will be censored on their last follow-up date. PFS will be estimated using the method of Kaplan-Meier. Progression is defined using RECIST 1.1 criteria; Progression: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression), Unequivocal progression (see comments below) of existing non-target lesions. (Note: the appearance of one or more new lesions is also considered progression), or appearance of new malignant lesions.

    Measured: 1 year 4 months

  3. Overall Survival (OS)

    Overall survival (OS) is defined as the time from registration to death from any cause. OS will be estimated using the method of Kaplan-Meier.

    Measured: 1 year 4 months

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

    The outcome measure is the number of participants experiencing at least one grade 3 or worse adverse event (AE).

    Measured: 1 year 4 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Mar 2018
  2. Study start30 Mar 2018
  3. Primary completion31 Jul 2019
  4. Study completion31 Jul 2019

Why it stopped: The study is closed per results from the interim analysis.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
22 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03456700
Sponsor's protocol ID
MC1761
Other IDs
NCI-2018-00321, MC1761, 17-005302
Status last verified
Apr 2025
First submitted
1 Mar 2018
Last updated
8 May 2025
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Jatoi A, Foster NR, Wahner Hendrickson A, Block MS, Weroha SJ, Asmus EJ, Murray NR, Fields AP. A Phase 2 Trial of Protein Kinase C Iota Inhibition With the Combination of Auranofin and Sirolimus in Patients With Recurrent Ovarian Cancer. Am J Clin Oncol. 2026 May 1;49(5):238-242. doi: 10.1097/COC.0000000000001263. Epub 2025 Oct 20.

    PubMed 41114938

  • Rousselle B, Massot A, Privat M, Dondaine L, Trommenschlager A, Bouyer F, Bayardon J, Ghiringhelli F, Bettaieb A, Goze C, Paul C, Malacea-Kabbara R, Bodio E. Conception and Evaluation of Fluorescent Phosphine-Gold Complexes: From Synthesis to in vivo Investigations. ChemMedChem. 2022 Jun 3;17(11):e202100773. doi: 10.1002/cmdc.202100773. Epub 2022 Mar 29.

    PubMed 35254001

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Auranofin, Laboratory Biomarker Analysis and Sirolimus in people with Ovarian Serous Tumor and Recurrent Ovarian Carcinoma, run by Mayo Clinic at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 8 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Jul 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With a Confirmed Tumor Response (Partial Response [PR] or Complete Response [CR] at Least 4 Weeks Apart) (time frame: 1 year 4 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03456700, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2025.

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