Trial · NCT03456700
Auranofin and Sirolimus in Treating Participants With Ovarian Cancer
NCT03456700, Phase 2, Terminated, Mayo Clinic; results first posted 2020-07-02
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Auranofin and Sirolimus in Treating Participants With Ovarian Cancer. Trials, record NCT03456700. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03456700
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Auranofin and Sirolimus in Treating Participants With Ovarian Cancer
- NCT number
- NCT03456700
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 22 participants, actual
- Lead sponsor
- Mayo Clinic
- Conditions
- Ovarian Serous Tumor, Recurrent Ovarian Carcinoma
- Interventions
- Auranofin, Laboratory Biomarker Analysis, Sirolimus
- First posted
- 2018-03-07
- Last updated
- 2025-05-08
- Results first posted
- 2020-07-02
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With a Confirmed Tumor Response (Partial Response [PR] or Complete Response [CR] at Least 4 Weeks Apart) | 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. |
| Secondary | 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 | 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. |
| Secondary | Progression-free Survival (PFS) | 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. |
| Secondary | Overall Survival (OS) | 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. |
| Secondary | Number of Participants Experiencing at Least One Grade 3 or Worse Adverse Event (AE) | 1 year 4 months | The outcome measure is the number of participants experiencing at least one grade 3 or worse adverse event (AE). |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With a Confirmed Tumor Response (Partial Response [PR] or Complete Response [CR] at Least 4 Weeks Apart) | 1 year 4 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | 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 | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Progression-free Survival (PFS) | 1 year 4 months | months | MEDIAN | |
| SECONDARY | Overall Survival (OS) | 1 year 4 months | months | MEDIAN | |
| SECONDARY | Number of Participants Experiencing at Least One Grade 3 or Worse Adverse Event (AE) | 1 year 4 months | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group5
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With a Confirmed Tumor Response (Partial Response [PR] or Complete Response [CR] at Least 4 Weeks Apart) | Treatment (Auranofin, Sirolimus) | 0 | Participants | ||
| 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 | Treatment (Auranofin, Sirolimus) | 0 | Participants | ||
| Progression-free Survival (PFS) | Treatment (Auranofin, Sirolimus) | 2.1 | 95% Confidence Interval 1.8 to 3.7 | months | |
| Overall Survival (OS) | Treatment (Auranofin, Sirolimus) | 4.4 | 95% Confidence Interval 2.6 to 12.5 | months | |
| Number of Participants Experiencing at Least One Grade 3 or Worse Adverse Event (AE) | Treatment (Auranofin, Sirolimus) | 13 | Participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Treatment (Auranofin, Sirolimus) | 22 | |
| Overall Study | COMPLETED | Treatment (Auranofin, Sirolimus) | 21 | |
| Overall Study | NOT COMPLETED | Treatment (Auranofin, Sirolimus) | 1 |
Source ClinicalTrials.gov
Adverse events44
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anemia | Blood and lymphatic system disorders | Treatment (Auranofin, Sirolimus) | 16 | 21 | 26 |
| other | Abdominal pain | Gastrointestinal disorders | Treatment (Auranofin, Sirolimus) | 1 | 21 | 1 |
| other | Diarrhea | Gastrointestinal disorders | Treatment (Auranofin, Sirolimus) | 17 | 21 | 32 |
| other | Mucositis oral | Gastrointestinal disorders | Treatment (Auranofin, Sirolimus) | 12 | 21 | 20 |
| other | Nausea | Gastrointestinal disorders | Treatment (Auranofin, Sirolimus) | 11 | 21 | 17 |
| other | Vomiting | Gastrointestinal disorders | Treatment (Auranofin, Sirolimus) | 9 | 21 | 12 |
| other | Edema limbs | General disorders | Treatment (Auranofin, Sirolimus) | 3 | 21 | 5 |
| other | Fatigue | General disorders | Treatment (Auranofin, Sirolimus) | 19 | 21 | 40 |
| other | Alkaline phosphatase increased | Investigations | Treatment (Auranofin, Sirolimus) | 2 | 21 | 3 |
| other | Cholesterol high | Investigations | Treatment (Auranofin, Sirolimus) | 1 | 21 | 1 |
1 to 10 of 44Source ClinicalTrials.gov
See all 44 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treatment (Auranofin, Sirolimus) | 19 | 21 |
| Total, other adverse events | Treatment (Auranofin, Sirolimus) | 20 | 21 |
| Total, serious adverse events | Treatment (Auranofin, Sirolimus) | 9 | 21 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| P30CA015083 | Mayo Clinic Comprehensive Cancer Center Support Grant | WILLMAN, CHERYL LYNN | MAYO CLINIC ROCHESTER | NATIONAL CANCER INSTITUTE | 1985 to 2025 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03456700
GET https://conductscience.org/api/trials/v1/NCT03456700/events?page=2