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Trial record 24 of 171 for:    ovarian cancer and Minnesota

Auranofin and Sirolimus in Treating Participants With Ovarian Cancer

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ClinicalTrials.gov Identifier: NCT03456700
Recruitment Status : Recruiting
First Posted : March 7, 2018
Last Update Posted : April 3, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Mayo Clinic

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.

Condition or disease Intervention/treatment Phase
Ovarian Serous Tumor Recurrent Ovarian Carcinoma Drug: Auranofin Other: Laboratory Biomarker Analysis Drug: Sirolimus Phase 2

Detailed Description:

PRIMARY OBJECTIVES:

I. 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:

I. 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:

I. 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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Trial to Evaluate the Efficacy of Auranofin and Sirolimus in Serous Ovarian Cancer Patients With Recurrent Disease
Actual Study Start Date : March 30, 2018
Estimated Primary Completion Date : March 15, 2023
Estimated Study Completion Date : March 15, 2023


Arm Intervention/treatment
Experimental: Treatment (auranofin, sirolimus)
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
Given PO
Other Name: Ridaura

Other: Laboratory Biomarker Analysis
Correlative studies

Drug: Sirolimus
Given PO
Other Names:
  • AY 22989
  • RAPA
  • Rapamune
  • Rapamycin
  • SILA 9268A
  • WY-090217




Primary Outcome Measures :
  1. Proportion of patients with a confirmed tumor response (partial response [PR] or complete response [CR] at least 4 weeks apart) [ Time Frame: Up to 3 years ]
    Ninety-five percent confidence intervals for the true success proportion will be calculated according to the exact binomial method.


Secondary Outcome Measures :
  1. Incidence of adverse event (AE) [ Time Frame: Up to 3 years ]
    The maximum grade for each type of AE will be recorded for each patient, and frequency tables will be reviewed to determine AE patterns.

  2. Overall survival (OS) [ Time Frame: Time from registration to death from any cause, assessed up to 3 years ]
    OS will be estimated using the method of Kaplan-Meier.

  3. Progression-free survival (PFS) [ Time Frame: Time from registration to the first of either disease progression or death from any cause, assessed up to 3 years ]
    PFS will be estimated using the method of Kaplan-Meier.

  4. Proportion of patients with a confirmed tumor response (PR or CR at least 4 weeks apart) in the subset of patients that have overexpression of PKCiota [ Time Frame: Up to 3 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Eastern Cooperative Oncology Group (ECOG) performance score of 0 or 1
  • Ovarian 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03456700


Locations
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Clincial Trials Referral Office    855-776-0015      
Principal Investigator: Aminah Jatoi         
Sponsors and Collaborators
Mayo Clinic
National Cancer Institute (NCI)
Investigators
Principal Investigator: Aminah Jatoi Mayo Clinic

Responsible Party: Mayo Clinic
ClinicalTrials.gov Identifier: NCT03456700     History of Changes
Other Study ID Numbers: MC1761
NCI-2018-00321 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
MC1761 ( Other Identifier: Mayo Clinic )
P30CA015083 ( U.S. NIH Grant/Contract )
First Posted: March 7, 2018    Key Record Dates
Last Update Posted: April 3, 2018
Last Verified: April 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Adnexal Diseases
Genital Diseases, Female
Endocrine System Diseases
Gonadal Disorders
Sirolimus
Everolimus
Auranofin
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents