Trial · NCT01642186
Study of (1) Everolimus, (2) Estrogen Deprivation Therapy (EDT) With Leuprolide + Letrozole and (3) Everolimus + EDT in Patients With Unresectable Fibrolamellar Hepatocellular Carcinoma (FLL-HCC)
NCT01642186, Phase 2, Completed, Memorial Sloan Kettering Cancer Center; results first posted 2022-12-29
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study of (1) Everolimus, (2) Estrogen Deprivation Therapy (EDT) With Leuprolide + Letrozole and (3) Everolimus + EDT in Patients With Unresectable Fibrolamellar Hepatocellular Carcinoma (FLL-HCC). Trials, record NCT01642186. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01642186
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of (1) Everolimus, (2) Estrogen Deprivation Therapy (EDT) With Leuprolide + Letrozole and (3) Everolimus + EDT in Patients With Unresectable Fibrolamellar Hepatocellular Carcinoma (FLL-HCC)
- NCT number
- NCT01642186
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 28 participants, actual
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Conditions
- Fibrolamellar Carcinoma, Fibrolamellar Liver Cancer
- Interventions
- everolimus, letrozole plus leuprolide, combination of everolimus, letrozole and leuprolide
- First posted
- 2012-07-17
- Last updated
- 2022-12-29
- Results first posted
- 2022-12-29
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Efficacy Endpoints for Part 1 of the Study is Progression-free Survival at 6 Months (PFS6) | 6 months | for Part 1 of the study is progression-free survival at 6 months (PFS6). A progression event refers to the first evidence of radiographic disease progression, clinical progression as determined by study investigators, or death. Imaging performed in 6 months will be used to determine PFS6. |
| Secondary | Median PFS | 2 years | Kaplan-Meier PFS will be measured from the date that study therapy is initiated until the date of first evidence of radiographic disease progression, global clinical deterioration as determined by study investigators, or death. |
| Secondary | Median Overall Survival (OS) | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months | Kaplan-Meier OS will be measured from the date that study therapy was commenced until the date of death. |
| Secondary | Percentage of Participants With Stable Disease | 2 years | Objective responses will be reported using RECIST guidelines (version 1.1). Objective response will be estimated using binomial proportions and exact 95% CIs will be provided. Stable Disease is defined as neither sufficient shrinkage (compared to baseline) to qualify for Partial Reponse nor sufficient increase (taking as reference the smallest sum diameters while on study) to qualify for Progressive Disease. |
| Secondary | Number of Participants With One or More Adverse Events/Toxicity | 2 years | Adverse events/toxicity will be monitored and recorded using the CTCAE version 4.0 and summarized descriptively. |
| Secondary | Number of Participants With Tissue Biomarkers Collected | 2 years | Associations between baseline tissue biomarkers and PFS6 will be assessed using Fisher's exact test for categorical biomarkers, trend tests for ordinal biomarkers and Wilcoxon rank-sum test for continuous biomarkers. For patients undergoing surgery, changes in tissue biomarkers from baseline to surgery will be summarized descriptively in an exploratory fashion. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Efficacy Endpoints for Part 1 of the Study is Progression-free Survival at 6 Months (PFS6) | 6 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Median PFS | 2 years | months | MEDIAN | |
| SECONDARY | Median Overall Survival (OS) | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months | months | MEDIAN | |
| SECONDARY | Percentage of Participants With Stable Disease | 2 years | Percentage of pts with stable disease | NUMBER | |
| SECONDARY | Number of Participants With One or More Adverse Events/Toxicity | 2 years | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With Tissue Biomarkers Collected | 2 years | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group21
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Efficacy Endpoints for Part 1 of the Study is Progression-free Survival at 6 Months (PFS6) | Arm A Everolimus | Progression Free | 0 | Participants | |
| Efficacy Endpoints for Part 1 of the Study is Progression-free Survival at 6 Months (PFS6) | Arm B Letrozole Plus Leuprolide | Progression Free | 0 | Participants | |
| Efficacy Endpoints for Part 1 of the Study is Progression-free Survival at 6 Months (PFS6) | Arm C Combination Everolimus, Letrozole and Leuprolide | Progression Free | 0 | Participants | |
| Efficacy Endpoints for Part 1 of the Study is Progression-free Survival at 6 Months (PFS6) | Arm A Everolimus | Participants With Progression | 9 | Participants | |
| Efficacy Endpoints for Part 1 of the Study is Progression-free Survival at 6 Months (PFS6) | Arm B Letrozole Plus Leuprolide | Participants With Progression | 9 | Participants | |
| Efficacy Endpoints for Part 1 of the Study is Progression-free Survival at 6 Months (PFS6) | Arm C Combination Everolimus, Letrozole and Leuprolide | Participants With Progression | 10 | Participants | |
| Median PFS | Arm A Everolimus | 2.6 | Full Range 0.9 to 5.5 | months | |
| Median PFS | Arm B Letrozole Plus Leuprolide | 2.7 | Full Range 1.7 to 5.2 | months | |
| Median PFS | Arm C Combination Everolimus, Letrozole and Leuprolide | 2.4 | Full Range 1.0 to 2.9 | months | |
| Median Overall Survival (OS) | Arm A Everolimus | 12.5 | Full Range 2.7 to 41.9 | months |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm A Everolimus | 9 | |
| Overall Study | STARTED | Arm B Letrozole Plus Leuprolide | 9 | |
| Overall Study | STARTED | Arm C Combination Everolimus, Letrozole and Leuprolide | 10 | |
| Overall Study | COMPLETED | Arm A Everolimus | 9 | |
| Overall Study | COMPLETED | Arm B Letrozole Plus Leuprolide | 7 | |
| Overall Study | COMPLETED | Arm C Combination Everolimus, Letrozole and Leuprolide | 7 | |
| Overall Study | NOT COMPLETED | Arm A Everolimus | 0 | |
| Overall Study | NOT COMPLETED | Arm B Letrozole Plus Leuprolide | 2 | |
| Overall Study | NOT COMPLETED | Arm C Combination Everolimus, Letrozole and Leuprolide | 3 |
Source ClinicalTrials.gov
Adverse events54
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 | ALT increased | Investigations | Arm A Everolimus | 7 | 9 | |
| other | ALT increased | Investigations | Arm B Letrozole Plus Leuprolide | 7 | 9 | |
| other | ALT increased | Investigations | Arm C Combination Everolimus, Letrozole and Leuprolide | 8 | 10 | |
| other | Alkaline phosphatase increased | Investigations | Arm A Everolimus | 7 | 9 | |
| other | Alkaline phosphatase increased | Investigations | Arm B Letrozole Plus Leuprolide | 8 | 9 | |
| other | Alkaline phosphatase increased | Investigations | Arm C Combination Everolimus, Letrozole and Leuprolide | 9 | 10 | |
| other | Anemia | Blood and lymphatic system disorders | Arm A Everolimus | 4 | 9 | |
| other | Anemia | Blood and lymphatic system disorders | Arm B Letrozole Plus Leuprolide | 8 | 9 | |
| other | Anemia | Blood and lymphatic system disorders | Arm C Combination Everolimus, Letrozole and Leuprolide | 8 | 10 | |
| other | AST increased | Investigations | Arm A Everolimus | 8 | 9 |
1 to 10 of 54Source ClinicalTrials.gov
See all 54 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm A Everolimus | 0 | 9 |
| Total, all-cause mortality | Arm B Letrozole Plus Leuprolide | 2 | 9 |
| Total, all-cause mortality | Arm C Combination Everolimus, Letrozole and Leuprolide | 2 | 10 |
| Total, other adverse events | Arm A Everolimus | 9 | 9 |
| Total, other adverse events | Arm B Letrozole Plus Leuprolide | 9 | 9 |
| Total, other adverse events | Arm C Combination Everolimus, Letrozole and Leuprolide | 9 | 10 |
| Total, serious adverse events | Arm A Everolimus | 0 | 9 |
| Total, serious adverse events | Arm B Letrozole Plus Leuprolide | 0 | 9 |
| Total, serious adverse events | Arm C Combination Everolimus, Letrozole and Leuprolide | 0 | 10 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 25486412 | DERIVED |
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/NCT01642186
GET https://conductscience.org/api/trials/v1/NCT01642186/results?page=2