Clinical trial · Interventional
Auranofin and Sirolimus in Treating Participants With Ovarian Cancer
Phase II Trial to Evaluate the Efficacy of Auranofin and Sirolimus in Serous Ovarian Cancer Patients With Recurrent Disease
NCT03456700CI-TRIAL-00089458terminatedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The study is closed per results from the interim analysis.
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ovarian Serous Tumor | Ovarian Serous Tumor | ONTOLOGY_EXACT | 0.98 |
| Recurrent Ovarian Carcinoma | Ovarian Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Auranofin | Drug | — | UNRESOLVED |
| Laboratory Biomarker Analysis | Other | — | UNRESOLVED |
| Sirolimus | Drug | Sirolimus | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (auranofin, sirolimus)
- description
- 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.
- interventionNames
- Drug: Auranofin
- Other: Laboratory Biomarker Analysis
- Drug: Sirolimus
Primary outcomes (1)
- measure
- Number of Participants With a Confirmed Tumor Response (Partial Response [PR] or Complete Response [CR] at Least 4 Weeks Apart)
- timeFrame
- 1 year 4 months
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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 * 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 Exclusion Criteria: * 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
References
Publications (2)
- DERIVEDJatoi 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. PMID 41114938
- DERIVEDRousselle 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