Trial · NCT02539459
Sporadic Angiomyolipomas (AMLs) Growth Kinetics While on Everolimus
NCT02539459, Phase 2, Terminated, Fox Chase Cancer Center; results first posted 2021-02-17
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Sporadic Angiomyolipomas (AMLs) Growth Kinetics While on Everolimus. Trials, record NCT02539459. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02539459
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Sporadic Angiomyolipomas (AMLs) Growth Kinetics While on Everolimus
- NCT number
- NCT02539459
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 20 participants, actual
- Lead sponsor
- Fox Chase Cancer Center
- Conditions
- Sporadic Angiomyolipomas (AMLs)
- Interventions
- Everolimus
- First posted
- 2015-09-03
- Last updated
- 2022-12-15
- Results first posted
- 2021-02-17
- Limitations and caveats
Lack of tissue to correlate response to molecular markers of aberrant mTOR pathways. Lack for serum everolimus levels. Clinical significance of 25% volume reduction unknown. Patient withdrawals and incomplete protocol imaging.
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Patients With Tumor Volume Reduction Greater Than 25% | 12 months | Measuring the efficacy and tolerability of everolimus by measuring the number of patients with tumor volume reduction greater than 25% in sporadic AMLs as measured by DCE MRI |
| Secondary | Safety and Tolerability of Everolimus in Patients With Sporadic AML | 12 months | Number of participants with treatment-related adverse events requiring dose reduction or study withdrawal as assessed by Common Toxicity Criteria for Adverse Effects (CTCAE v4.0) |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Patients With Tumor Volume Reduction Greater Than 25% | 12 months | Some participants experienced adverse events and were withdrawn from the study, and therefore tumor volume reduction was not measured in these patients. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Safety and Tolerability of Everolimus in Patients With Sporadic AML | 12 months | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Patients With Tumor Volume Reduction Greater Than 25% | Treatment (Everolimus) | 5 | Participants | ||
| Safety and Tolerability of Everolimus in Patients With Sporadic AML | Treatment (Everolimus) | 10 | 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 (Everolimus) | 20 | |
| Overall Study | COMPLETED | Treatment (Everolimus) | 18 | |
| Overall Study | NOT COMPLETED | Treatment (Everolimus) | 2 |
Source ClinicalTrials.gov
Adverse events37
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 | oral mucositis | Infections and infestations | Treatment (Everolimus) | 14 | 20 | 20 |
| other | Alanine aminotransferase increase | Renal and urinary disorders | Treatment (Everolimus) | 10 | 20 | |
| other | anemia | Blood and lymphatic system disorders | Treatment (Everolimus) | 9 | 20 | |
| other | Aspartate aminotransferase increase | Renal and urinary disorders | Treatment (Everolimus) | 9 | 20 | |
| other | fatigue | General disorders | Treatment (Everolimus) | 7 | 20 | |
| other | Hypercholesterolemia | Blood and lymphatic system disorders | Treatment (Everolimus) | 7 | 20 | |
| other | Maculopapular rash | Skin and subcutaneous tissue disorders | Treatment (Everolimus) | 7 | 20 | |
| other | diarrhea | Gastrointestinal disorders | Treatment (Everolimus) | 5 | 20 | |
| other | Leukocyte decrease | Blood and lymphatic system disorders | Treatment (Everolimus) | 5 | 20 | |
| other | Hypertriglyceridemia | Blood and lymphatic system disorders | Treatment (Everolimus) | 4 | 20 |
1 to 10 of 37Source ClinicalTrials.gov
See all 37 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treatment (Everolimus) | 0 | 20 |
| Total, other adverse events | Treatment (Everolimus) | 20 | 20 |
| Total, serious adverse events | Treatment (Everolimus) | 3 | 20 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 32250730 | RESULT |
Source PubMed
Grants0
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.
None in this release.
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/NCT02539459
GET https://conductscience.org/api/trials/v1/NCT02539459/events?page=2