Trial · NCT00510068
Efficacy and Safety of Everolimus (RAD001) Compared to Placebo in Patients With Advanced Neuroendocrine Tumors
NCT00510068, Phase 3, Completed, Novartis Pharmaceuticals; results first posted 2011-12-15
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy and Safety of Everolimus (RAD001) Compared to Placebo in Patients With Advanced Neuroendocrine Tumors. Trials, record NCT00510068. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00510068
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of Everolimus (RAD001) Compared to Placebo in Patients With Advanced Neuroendocrine Tumors
- NCT number
- NCT00510068
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 410 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Advanced Neuroendocrine Tumors of Pancreatic Origin
- Interventions
- Everolimus, Everolimus Placebo
- First posted
- 2007-08-01
- Last updated
- 2015-07-01
- Other registries' IDs
- eudract:2006-006819-75
- Results first posted
- 2011-12-15
Source ClinicalTrials.gov
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Time to Progression Free Survival (PFS) Based as Per Investigator Using Kaplan-Meier Methodology | Time from randomisation to dates of disease progression, death from any cause or last tumor assessment, reported between day of first patient randomised, 17 August 2007, until cut-off date 28 February 2010 | Progression of disease is defined as the time from study start to the date of first documented progression of disease or death due to any cause. Progression of disease is defined by RECIST criteria: Progression = 20% increase in the sum of the longest diameter of all target lesions, from the smallest sum of longest diameter of all target lesions recorded at or after baseline; or a new lesion; or progression of non-target lesions. |
| Secondary | Percentage of Participants With Objective Response Rate ( CR {Complete Response} OR PR {Partial Response}) | Time from randomisation to dates of disease progression, death from any cause or last tumor assessment, reported between day of first patient randomised, 17 August 2007, until cut-off date 28 February 2010 | Objective Response defined by RECIST criteria: Partial response (PR) must have ≥ 30% decrease in the sum of the longest diameter of all target lesions, from the baseline sum. Complete response (CR) must have disappearance of all target and non-target lesions. For CR or PR, tumor measurements must be confirmed by 2nd assessments within 4 weeks . Progression = 20% increase in the sum of the longest diameter of all target lesions, from the smallest sum of longest diameter of all target lesions recorded at or after baseline; or a new lesion; or progression of non-target lesions |
| Secondary | Overall Survival | Baseline, to death- no time limit | Overall survival (OS) was defined as the time from date of randomization to the date of death due to any cause. Analyses were performed using all deaths in the FAS population regardless of whether they were observed during the double-blind treatment period, the open-label treatment period, the post-treatment evaluations, or the survival follow-up period. |
| Secondary | Progression Free Survival According to Ki-67 Levels Categorized as: Less Than or Equal to 2%, > 2% to Less Than or Equal to 5% and > 5% | Time from randomisation to dates of disease progression, death from any cause or last tumor assessment, reported between day of first patient randomised, 17 August 2007, until cut-off date 28 February 2010 | The level of Ki 67 expression for evaluable tumor samples were analyzed towards progression free survival (PFS) as per local investigator assessment. The Ki-67 protein is a cellular marker for proliferation. It is strictly associated with cell proliferation. During interphase, the Ki-67 antigen can be exclusively detected within the cell nucleus, whereas in mitosis most of the protein is relocated to the surface of the chromosomes. Baseline Ki 67 levels were categorized as: less than or equal to 2%, \> 2% to less than or equal to 5% and \> 5%. |
| Secondary | Progression Free Survival According to Chromogramin A Tumor Marker (CgA) Baseline Level and According to CgA Early Response | Time from randomisation to dates of disease progression, death from any cause or last tumor assessment, reported between day of first patient randomised, 17 August 2007, until cut-off date 28 February 2010 | Baseline levels of serum CgA SE were characterized towards progression free survival (PFS) as per local investigator assessment, relative to the upper limited of normal (ULN). CgA levels exceeding 2 x ULN were considered to be 'Elevated' otherwise considered as "Non-elevated". An 'early response' (applicable to only those patients with elevated levels at baseline) was defined as a decrease of greater than or equal to 30% from baseline to Cycle 2 Day 1 or normalization by Cycle 2 Day 1. CgA is widely expressed in well-differentiated pancreatic NET. CgA is present in the secretory granules of neuroendocrine cells. Pancreatic NET patients often present with elevated circulating levels of CgA in their blood. Baseline levels of these biomarkers are considered as prognostic factors. |
| Secondary | Progression Free Survival According to Neuron Specific Enolase Tumor Marker (NSE) Baseline Level and According to NSE Early Response | Time from randomisation to dates of disease progression, death from any cause or last tumor assessment, reported between day of first patient randomised, 17 August 2007, until cut-off date 28 February 2010 | Baseline levels of serum NSE were characterized towards PFS as per local investigator assessment, relative to the upper limited of normal (ULN). NSE levels exceeding ULN were considered to be 'Elevated' otherwise considered as "Non-elevated". An 'early response' (applicable to only those patients with elevated levels at baseline) was defined as a decrease of greater than or equal to 30% from baseline to Cycle 2 Day 1 or normalization by Cycle 2 Day 1. NSE is widely expressed in well-differentiated pancreatic NET. NSE is usually expressed in the cytoplasm. Pancreatic NET patients often present with elevated circulating levels of NSE in their blood. Baseline levels of these biomarkers are considered as prognostic factors. |
| Secondary | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) | on or after the start of double-blind study medication until no later than 28 days after double-blind study medication discontinuation | Adverse events are defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse events are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgment of investigators represent significant hazards. |
| Secondary | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) (Open-label Period) | on or after the start of open-label study medication until no later than 28 days after open-label study medication discontinuation | Adverse events are defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse events are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgment of investigators represent significant hazards. |
| Secondary | Evaluation of Pharmacokinetics (PK) Parameter: AUC0-t Last | Day 1 of every cycle (28 days/cycle) throughout the study | The PK parameters for a full PK profile at steady-state were determined in blood using non compartmental methods. This PK parameter is area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUC0-t last). |
| Secondary | Evaluation of Pharmacokinetics (PK) Parameters: Cmax, Cmin | Day 1 of every cycle (28 days/cycle) throughout the study | The PK parameters for a full PK profile at steady-state were determined in blood using non compartmental methods. The PK parameter: maximum (peak) drug concentration (Cmax) and minimum (trough) drug concentration (Cmin). |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 registered outcomesOutcomes18
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Time to Progression Free Survival (PFS) Based as Per Investigator Using Kaplan-Meier Methodology | Time from randomisation to dates of disease progression, death from any cause or last tumor assessment, reported between day of first patient randomised, 17 August 2007, until cut-off date 28 February 2010 | The Full Analysis Set (FAS) consists of all patients who were randomized. | Months | MEDIAN |
| SECONDARY | Percentage of Participants With Objective Response Rate ( CR {Complete Response} OR PR {Partial Response}) | Time from randomisation to dates of disease progression, death from any cause or last tumor assessment, reported between day of first patient randomised, 17 August 2007, until cut-off date 28 February 2010 | The Full Analysis Set (FAS) consists of all patients who were randomized. | Percentage of participants | NUMBER |
| SECONDARY | Overall Survival | Baseline, to death- no time limit | The Full Analysis Set (FAS) included all randomized patients. | Months | MEDIAN |
| SECONDARY | Progression Free Survival According to Ki-67 Levels Categorized as: Less Than or Equal to 2%, > 2% to Less Than or Equal to 5% and > 5% | Time from randomisation to dates of disease progression, death from any cause or last tumor assessment, reported between day of first patient randomised, 17 August 2007, until cut-off date 28 February 2010 | The Full Analysis Set (FAS) consisted of all patients who were randomized. | Months | MEDIAN |
| SECONDARY | Progression Free Survival According to Chromogramin A Tumor Marker (CgA) Baseline Level and According to CgA Early Response | Time from randomisation to dates of disease progression, death from any cause or last tumor assessment, reported between day of first patient randomised, 17 August 2007, until cut-off date 28 February 2010 | The Full Analysis Set (FAS) consisted of all patients who were randomized. | Months | MEDIAN |
| SECONDARY | Progression Free Survival According to Neuron Specific Enolase Tumor Marker (NSE) Baseline Level and According to NSE Early Response | Time from randomisation to dates of disease progression, death from any cause or last tumor assessment, reported between day of first patient randomised, 17 August 2007, until cut-off date 28 February 2010 | The Full Analysis Set (FAS) consisted of all patients who were randomized. | Months | MEDIAN |
| SECONDARY | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) | on or after the start of double-blind study medication until no later than 28 days after double-blind study medication discontinuation | The Safety Set consists of all patients who received any study drug and had at least one post-baseline safety assessment. | Participants | NUMBER |
| SECONDARY | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) (Open-label Period) | on or after the start of open-label study medication until no later than 28 days after open-label study medication discontinuation | The open-label set was used to summarize the safety analyses performed on data collected in the open-label period of the study: the open-label set included only patients who received at least one dose of open-label everolimus 10 mg and had at least one safety assessment during the open-label period of the study. | Participants | NUMBER |
| SECONDARY | Evaluation of Pharmacokinetics (PK) Parameter: AUC0-t Last | Day 1 of every cycle (28 days/cycle) throughout the study | The Safety Set consisted of all patients who received any study drug and had at least one postbaseline safety assessment. | ng.h/mL | MEAN |
| SECONDARY | Evaluation of Pharmacokinetics (PK) Parameters: Cmax, Cmin | Day 1 of every cycle (28 days/cycle) throughout the study | The Safety Set consisted of all patients who received any study drug and had at least one postbaseline safety assessment. | ng/mL | MEAN |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 outcomesResults by group91
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Time to Progression Free Survival (PFS) Based as Per Investigator Using Kaplan-Meier Methodology | Everolimus 10 mg/Day | 11.04 | 95% Confidence Interval 8.41 to 13.86 | Months | |
| Time to Progression Free Survival (PFS) Based as Per Investigator Using Kaplan-Meier Methodology | Placebo | 4.60 | 95% Confidence Interval 3.06 to 5.39 | Months | |
| Percentage of Participants With Objective Response Rate ( CR {Complete Response} OR PR {Partial Response}) | Everolimus 10 mg/Day | 4.8 | 95% Confidence Interval 2.3 to 8.7 | Percentage of participants | |
| Percentage of Participants With Objective Response Rate ( CR {Complete Response} OR PR {Partial Response}) | Placebo | 2.0 | 95% Confidence Interval 0.5 to 5.0 | Percentage of participants | |
| Overall Survival | Everolimus 10 mg/Day | 44.02 | 95% Confidence Interval 35.61 to 51.75 | Months | |
| Overall Survival | Placebo | 37.68 | 95% Confidence Interval 29.14 to 45.77 | Months | |
| Progression Free Survival According to Ki-67 Levels Categorized as: Less Than or Equal to 2%, > 2% to Less Than or Equal to 5% and > 5% | Everolimus 10 mg/Day | Ki67 <=2% (n: 7, 17) | 12.52 | 95% Confidence Interval 3.42 to 14.75 | Months |
| Progression Free Survival According to Ki-67 Levels Categorized as: Less Than or Equal to 2%, > 2% to Less Than or Equal to 5% and > 5% | Placebo | Ki67 <=2% (n: 7, 17) | 3.68 | 95% Confidence Interval 2.86 to 5.52 | Months |
| Progression Free Survival According to Ki-67 Levels Categorized as: Less Than or Equal to 2%, > 2% to Less Than or Equal to 5% and > 5% | Everolimus 10 mg/Day | 2% <Ki67 <=5% (n: 24, 13) | 10.94 | 95% Confidence Interval 5.55 to 16.59 | Months |
| Progression Free Survival According to Ki-67 Levels Categorized as: Less Than or Equal to 2%, > 2% to Less Than or Equal to 5% and > 5% | Placebo | 2% <Ki67 <=5% (n: 24, 13) | 8.48 | 95% Confidence Interval 3.78 to 13.83 | Months |
1 to 10 of 91Source ClinicalTrials.gov
See all 91 results by groupParticipant flow14
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Double-blind Period | STARTED | Everolimus 10 mg/Day | 207 | |
| Double-blind Period | STARTED | Placebo | 203 | |
| Double-blind Period | Safety Population | Everolimus 10 mg/Day | 204 | |
| Double-blind Period | Safety Population | Placebo | 203 | |
| Double-blind Period | COMPLETED | Everolimus 10 mg/Day | 0 | |
| Double-blind Period | COMPLETED | Placebo | 0 | |
| Double-blind Period | NOT COMPLETED | Everolimus 10 mg/Day | 207 | |
| Double-blind Period | NOT COMPLETED | Placebo | 203 | |
| Open-label Period | STARTED | Everolimus 10 mg/Day | 225 | |
| Open-label Period | STARTED | Placebo | 0 |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 participant flowAdverse events984
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 | Anaemia | Blood and lymphatic system disorders | Everolimus 10mg/Day | 48 | 204 | |
| other | Anaemia | Blood and lymphatic system disorders | Placebo | 18 | 203 | |
| other | Anaemia | Blood and lymphatic system disorders | Open Label - Everolimus 10mg | 55 | 225 | |
| other | Leukopenia | Blood and lymphatic system disorders | Everolimus 10mg/Day | 12 | 204 | |
| other | Leukopenia | Blood and lymphatic system disorders | Placebo | 4 | 203 | |
| other | Leukopenia | Blood and lymphatic system disorders | Open Label - Everolimus 10mg | 9 | 225 | |
| other | Lymphopenia | Blood and lymphatic system disorders | Everolimus 10mg/Day | 15 | 204 | |
| other | Lymphopenia | Blood and lymphatic system disorders | Placebo | 6 | 203 | |
| other | Lymphopenia | Blood and lymphatic system disorders | Open Label - Everolimus 10mg | 10 | 225 | |
| other | Neutropenia | Blood and lymphatic system disorders | Everolimus 10mg/Day | 14 | 204 |
1 to 10 of 984Source ClinicalTrials.gov
See all 984 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Everolimus 10mg/Day | ||
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | Open Label - Everolimus 10mg | ||
| Total, other adverse events | Everolimus 10mg/Day | 201 | 204 |
| Total, other adverse events | Placebo | 190 | 203 |
| Total, other adverse events | Open Label - Everolimus 10mg | 218 | 225 |
| Total, serious adverse events | Everolimus 10mg/Day | 84 | 204 |
| Total, serious adverse events | Placebo | 52 | 203 |
| Total, serious adverse events | Open Label - Everolimus 10mg | 108 | 225 |
Source ClinicalTrials.gov
Papers5
The papers the trial lists on ClinicalTrials.gov.
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.
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Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
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