Auranofin and Sirolimus in Treating Participants With Ovarian Cancer

NCT03456700 | Terminated Phase 2 Results DMC FDA Drug

• 3 other identifiers: MC1761NCI-2018-0032117-005302
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Ovarian Serous Tumor; Recurrent Ovarian Carcinoma

Outcome Measures

Primary Outcomes (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.

  1 year 4 months

Secondary Outcomes (4)

• 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

  1 year 4 months

• Progression-free Survival (PFS)

  1 year 4 months

• Overall Survival (OS)

  1 year 4 months

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

  1 year 4 months

Study Arms (1)

Treatment (auranofin, sirolimus)

EXPERIMENTAL

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.

Drug: Auranofin; Other: Laboratory Biomarker Analysis; Drug: Sirolimus

Interventions

Auranofin DRUG

Given PO

Also known as: Ridaura

Treatment (auranofin, sirolimus)

Laboratory Biomarker Analysis OTHER

Correlative studies

Treatment (auranofin, sirolimus)

Sirolimus DRUG

Given PO

Also known as: AY 22989, RAPA, Rapamune, Rapamycin, SILA 9268A, WY-090217

Treatment (auranofin, sirolimus)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Publications (2)

• 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. 2025 Oct 20. doi: 10.1097/COC.0000000000001263. Online ahead of print.

  PMID: 41114938 DERIVED

• 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.

  PMID: 35254001 DERIVED

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

Auranofin; Sirolimus

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Aurothioglucose; Organogold Compounds; Organometallic Compounds; Organic Chemicals; Macrolides; Lactones

Results Point of Contact

• Title: Aminah Jatoi MD
• Organization: Mayo Clinic

Jatoi.Aminah@mayo.edu

507/284-2511

Study Officials

• Aminah Jatoi, M.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2018
• First Posted: March 7, 2018
• Study Start: March 30, 2018
• Primary Completion: July 31, 2019
• Study Completion: July 31, 2019
• Last Updated: May 8, 2025
• Results First Posted: July 2, 2020

Record last verified: 2025-04

Locations

US (1)