- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03456700
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
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Minnesota
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Rochester, Minnesota, United States, 55905
- Mayo Clinic
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
|
Correlative studies
Given PO
Other Names:
Given PO
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
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.
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1 year 4 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
Time Frame: 1 year 4 months
|
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.
|
1 year 4 months
|
Progression-free Survival (PFS)
Time Frame: 1 year 4 months
|
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.
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1 year 4 months
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Overall Survival (OS)
Time Frame: 1 year 4 months
|
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.
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1 year 4 months
|
Number of Participants Experiencing at Least One Grade 3 or Worse Adverse Event (AE)
Time Frame: 1 year 4 months
|
The outcome measure is the number of participants experiencing at least one grade 3 or worse adverse event (AE).
|
1 year 4 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Aminah Jatoi, M.D., Mayo Clinic
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MC1761 (Other Identifier: Mayo Clinic)
- P30CA015083 (U.S. NIH Grant/Contract)
- NCI-2018-00321 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
- 17-005302 (Other Identifier: Mayo Clinic Institutional Review Board)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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