Trial Outcomes & Findings for Auranofin and Sirolimus in Treating Participants With Ovarian Cancer (NCT NCT03456700)

Last Updated: 2025-05-08

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

22 participants

Primary outcome timeframe

1 year 4 months

Results posted on

2025-05-08

Participant Flow

Participant milestones

Participant milestones
Measure	Treatment (Auranofin, Sirolimus) Participants receive 6 mg auranofin PO QD and 5 mg sirolimus PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unaccepted toxicity.
Overall Study STARTED	22
Overall Study COMPLETED	21
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Treatment (Auranofin, Sirolimus) Participants receive 6 mg auranofin PO QD and 5 mg sirolimus PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unaccepted toxicity.
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Auranofin and Sirolimus in Treating Participants With Ovarian Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment (Auranofin, Sirolimus) n=21 Participants Participants receive 6 mg auranofin PO QD and 5 mg sirolimus PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unaccepted toxicity.
Age, Continuous	61 years n=5 Participants
Sex: Female, Male Female	21 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	20 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Received prior chemotherapy for this cancer	20 Participants n=5 Participants
Tumor Over-expression of Protein Kinase C (PKC) iota	21 Participants n=5 Participants

PRIMARY outcome

Timeframe: 1 year 4 months

Outcome measures

Outcome measures
Measure	Treatment (Auranofin, Sirolimus) n=21 Participants Participants receive 6 mg auranofin PO QD and 5 mg sirolimus PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unaccepted toxicity.
Number of Participants With a Confirmed Tumor Response (Partial Response [PR] or Complete Response [CR] at Least 4 Weeks Apart)	0 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Treatment (Auranofin, Sirolimus) n=21 Participants Participants receive 6 mg auranofin PO QD and 5 mg sirolimus PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unaccepted toxicity.
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	0 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Treatment (Auranofin, Sirolimus) n=21 Participants Participants receive 6 mg auranofin PO QD and 5 mg sirolimus PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unaccepted toxicity.
Progression-free Survival (PFS)	2.1 months Interval 1.8 to 3.7

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Treatment (Auranofin, Sirolimus) n=21 Participants Participants receive 6 mg auranofin PO QD and 5 mg sirolimus PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unaccepted toxicity.
Overall Survival (OS)	4.4 months Interval 2.6 to 12.5

SECONDARY outcome

Timeframe: 1 year 4 months

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

Outcome measures

Outcome measures
Measure	Treatment (Auranofin, Sirolimus) n=21 Participants Participants receive 6 mg auranofin PO QD and 5 mg sirolimus PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unaccepted toxicity.
Number of Participants Experiencing at Least One Grade 3 or Worse Adverse Event (AE)	13 Participants

Adverse Events

Treatment (Auranofin, Sirolimus)

Serious events: 9 serious events

Other events: 20 other events

Deaths: 19 deaths

Serious adverse events

Serious adverse events
Measure	Treatment (Auranofin, Sirolimus) n=21 participants at risk Participants receive 6 mg auranofin PO QD and 5 mg sirolimus PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unaccepted toxicity.
Gastrointestinal disorders Abdominal pain	4.8% 1/21 • Number of events 1 • Up to 2 years Participants evaluable for adverse events are summarized below (i.e. participants who did not withdraw consent).
Gastrointestinal disorders Mucositis oral	4.8% 1/21 • Number of events 1 • Up to 2 years Participants evaluable for adverse events are summarized below (i.e. participants who did not withdraw consent).
Gastrointestinal disorders Nausea	4.8% 1/21 • Number of events 1 • Up to 2 years Participants evaluable for adverse events are summarized below (i.e. participants who did not withdraw consent).
Gastrointestinal disorders Small intestinal obstruction	14.3% 3/21 • Number of events 3 • Up to 2 years Participants evaluable for adverse events are summarized below (i.e. participants who did not withdraw consent).
Gastrointestinal disorders Vomiting	9.5% 2/21 • Number of events 3 • Up to 2 years Participants evaluable for adverse events are summarized below (i.e. participants who did not withdraw consent).
General disorders Fatigue	4.8% 1/21 • Number of events 1 • Up to 2 years Participants evaluable for adverse events are summarized below (i.e. participants who did not withdraw consent).
General disorders Fever	4.8% 1/21 • Number of events 1 • Up to 2 years Participants evaluable for adverse events are summarized below (i.e. participants who did not withdraw consent).
Infections and infestations Sepsis	9.5% 2/21 • Number of events 2 • Up to 2 years Participants evaluable for adverse events are summarized below (i.e. participants who did not withdraw consent).
Metabolism and nutrition disorders Hypokalemia	4.8% 1/21 • Number of events 1 • Up to 2 years Participants evaluable for adverse events are summarized below (i.e. participants who did not withdraw consent).
Musculoskeletal and connective tissue disorders Flank pain	4.8% 1/21 • Number of events 1 • Up to 2 years Participants evaluable for adverse events are summarized below (i.e. participants who did not withdraw consent).
Renal and urinary disorders Urinary tract obstruction	4.8% 1/21 • Number of events 1 • Up to 2 years Participants evaluable for adverse events are summarized below (i.e. participants who did not withdraw consent).
Respiratory, thoracic and mediastinal disorders Resp, thoracic, mediastinal - Oth spec	4.8% 1/21 • Number of events 1 • Up to 2 years Participants evaluable for adverse events are summarized below (i.e. participants who did not withdraw consent).

Other adverse events

Other adverse events
Measure	Treatment (Auranofin, Sirolimus) n=21 participants at risk Participants receive 6 mg auranofin PO QD and 5 mg sirolimus PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unaccepted toxicity.
Blood and lymphatic system disorders Anemia	76.2% 16/21 • Number of events 26 • Up to 2 years Participants evaluable for adverse events are summarized below (i.e. participants who did not withdraw consent).
Gastrointestinal disorders Abdominal pain	4.8% 1/21 • Number of events 1 • Up to 2 years Participants evaluable for adverse events are summarized below (i.e. participants who did not withdraw consent).
Gastrointestinal disorders Diarrhea	81.0% 17/21 • Number of events 32 • Up to 2 years Participants evaluable for adverse events are summarized below (i.e. participants who did not withdraw consent).
Gastrointestinal disorders Mucositis oral	57.1% 12/21 • Number of events 20 • Up to 2 years Participants evaluable for adverse events are summarized below (i.e. participants who did not withdraw consent).
Gastrointestinal disorders Nausea	52.4% 11/21 • Number of events 17 • Up to 2 years Participants evaluable for adverse events are summarized below (i.e. participants who did not withdraw consent).
Gastrointestinal disorders Vomiting	42.9% 9/21 • Number of events 12 • Up to 2 years Participants evaluable for adverse events are summarized below (i.e. participants who did not withdraw consent).
General disorders Edema limbs	14.3% 3/21 • Number of events 5 • Up to 2 years Participants evaluable for adverse events are summarized below (i.e. participants who did not withdraw consent).
General disorders Fatigue	90.5% 19/21 • Number of events 40 • Up to 2 years Participants evaluable for adverse events are summarized below (i.e. participants who did not withdraw consent).
Investigations Alkaline phosphatase increased	9.5% 2/21 • Number of events 3 • Up to 2 years Participants evaluable for adverse events are summarized below (i.e. participants who did not withdraw consent).
Investigations Cholesterol high	4.8% 1/21 • Number of events 1 • Up to 2 years Participants evaluable for adverse events are summarized below (i.e. participants who did not withdraw consent).
Investigations Creatinine increased	14.3% 3/21 • Number of events 3 • Up to 2 years Participants evaluable for adverse events are summarized below (i.e. participants who did not withdraw consent).
Investigations Lymphocyte count decreased	33.3% 7/21 • Number of events 12 • Up to 2 years Participants evaluable for adverse events are summarized below (i.e. participants who did not withdraw consent).
Investigations Neutrophil count decreased	9.5% 2/21 • Number of events 2 • Up to 2 years Participants evaluable for adverse events are summarized below (i.e. participants who did not withdraw consent).
Investigations Platelet count decreased	28.6% 6/21 • Number of events 12 • Up to 2 years Participants evaluable for adverse events are summarized below (i.e. participants who did not withdraw consent).
Investigations White blood cell decreased	23.8% 5/21 • Number of events 5 • Up to 2 years Participants evaluable for adverse events are summarized below (i.e. participants who did not withdraw consent).
Metabolism and nutrition disorders Anorexia	28.6% 6/21 • Number of events 6 • Up to 2 years Participants evaluable for adverse events are summarized below (i.e. participants who did not withdraw consent).
Metabolism and nutrition disorders Hyperglycemia	4.8% 1/21 • Number of events 1 • Up to 2 years Participants evaluable for adverse events are summarized below (i.e. participants who did not withdraw consent).
Metabolism and nutrition disorders Hypertriglyceridemia	9.5% 2/21 • Number of events 2 • Up to 2 years Participants evaluable for adverse events are summarized below (i.e. participants who did not withdraw consent).
Musculoskeletal and connective tissue disorders Arthralgia	42.9% 9/21 • Number of events 15 • Up to 2 years Participants evaluable for adverse events are summarized below (i.e. participants who did not withdraw consent).
Musculoskeletal and connective tissue disorders Back pain	4.8% 1/21 • Number of events 1 • Up to 2 years Participants evaluable for adverse events are summarized below (i.e. participants who did not withdraw consent).
Musculoskeletal and connective tissue disorders Flank pain	4.8% 1/21 • Number of events 1 • Up to 2 years Participants evaluable for adverse events are summarized below (i.e. participants who did not withdraw consent).
Musculoskeletal and connective tissue disorders Myalgia	33.3% 7/21 • Number of events 12 • Up to 2 years Participants evaluable for adverse events are summarized below (i.e. participants who did not withdraw consent).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumor pain	4.8% 1/21 • Number of events 1 • Up to 2 years Participants evaluable for adverse events are summarized below (i.e. participants who did not withdraw consent).
Nervous system disorders Dizziness	38.1% 8/21 • Number of events 13 • Up to 2 years Participants evaluable for adverse events are summarized below (i.e. participants who did not withdraw consent).
Renal and urinary disorders Proteinuria	52.4% 11/21 • Number of events 14 • Up to 2 years Participants evaluable for adverse events are summarized below (i.e. participants who did not withdraw consent).
Respiratory, thoracic and mediastinal disorders Cough	4.8% 1/21 • Number of events 1 • Up to 2 years Participants evaluable for adverse events are summarized below (i.e. participants who did not withdraw consent).
Respiratory, thoracic and mediastinal disorders Dyspnea	19.0% 4/21 • Number of events 4 • Up to 2 years Participants evaluable for adverse events are summarized below (i.e. participants who did not withdraw consent).
Respiratory, thoracic and mediastinal disorders Pleural effusion	9.5% 2/21 • Number of events 2 • Up to 2 years Participants evaluable for adverse events are summarized below (i.e. participants who did not withdraw consent).
Respiratory, thoracic and mediastinal disorders Pneumonitis	14.3% 3/21 • Number of events 3 • Up to 2 years Participants evaluable for adverse events are summarized below (i.e. participants who did not withdraw consent).
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysesthesia syndrm	9.5% 2/21 • Number of events 5 • Up to 2 years Participants evaluable for adverse events are summarized below (i.e. participants who did not withdraw consent).
Skin and subcutaneous tissue disorders Rash maculo-papular	4.8% 1/21 • Number of events 2 • Up to 2 years Participants evaluable for adverse events are summarized below (i.e. participants who did not withdraw consent).
Vascular disorders Thromboembolic event	9.5% 2/21 • Number of events 2 • Up to 2 years Participants evaluable for adverse events are summarized below (i.e. participants who did not withdraw consent).

Additional Information

Aminah Jatoi MD

Mayo Clinic

Phone: 507/284-2511

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place