Trial · NCT00363051
Safety/Efficacy of Everolimus in Adults With Advanced Pancreatic Neuroendocrine Cancer Not Responsive to Chemotherapy
NCT00363051, Phase 2, Completed, Novartis Pharmaceuticals; results first posted 2012-03-30
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Safety/Efficacy of Everolimus in Adults With Advanced Pancreatic Neuroendocrine Cancer Not Responsive to Chemotherapy. Trials, record NCT00363051. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00363051
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety/Efficacy of Everolimus in Adults With Advanced Pancreatic Neuroendocrine Cancer Not Responsive to Chemotherapy
- NCT number
- NCT00363051
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 160 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Islet Cell Carcinoma, Neuroendocrine Carcinoma, Neuroendocrine Tumor, Pancreatic Neoplasms
- Interventions
- Everolimus 10 mg, Octreotide Depot
- First posted
- 2006-08-15
- Last updated
- 2013-05-10
- Results first posted
- 2012-03-30
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Objective Response Rate: Percentage of Participants With Best Over All Response of Complete Response or Partial Response by Central Radiology Review (Stratum 1) Based on Response Evaluation Criteria in Solid Tumors (RECIST) | from date of randomization/start of treatment until first documented response confirmed 4 weeks later( at least 3 months) | Objective response rate was defined by RECIST criteria: Partial response (PR) must have ≥ 30% decrease in the sum of 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 longest diameter of all target lesions, from 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 | Duration of Overall Response (Stratum 1) Based on Response Evaluation Criteria in Solid Tumors (RECIST)- Central Radiology Review | from date of first documented confirmed response to time to progression, at least 3 months | Duration of overall response applies only to patients whose best overall response was complete response (CR) or partial response (PR): * Complete Response (CR) = at least two determinations of CR at least 4 weeks apart before progression. * Partial response (PR) = at least two determinations of PR or better at least 4 weeks apart before progression. 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 | Duration of Overall Response (Stratum 2) Based on Response Evaluation Criteria in Solid Tumors (RECIST)- Central Radiology Review | from date of first documented confirmed response to time to progression, at least 3 months | Duration of overall response applies only to patients whose best overall response was complete response (CR) or partial response (PR): * Complete Response (CR) = at least two determinations of CR at least 4 weeks apart before progression. * Partial response (PR) = at least two determinations of PR or better at least 4 weeks apart before progression. 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 | Objective Response Rate: Percentage of Participants With Best Over All Response of Complete Response or Partial Response by Central Radiology Review (Stratum 2) Based on Response Evaluation Criteria in Solid Tumors (RECIST) | from date of randomization/start of treatment until first documented response confirmed 4 weeks later (at least 3 months) | Objective response rate was defined by RECIST criteria: Partial response (PR) must have ≥ 30% decrease in the sum of 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 longest diameter of all target lesions, from 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 | Number of Participants With Adverse Events (AEs), Death, Serious Adverse Events (SAEs)[Stratum 1] | on or after the day of the first intake of study treatment to starting no later than 28 days after study treatment discontinuation, at least every month | 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), Death, Serious Adverse Events (SAEs) [Stratum 2] | on or after the day of the first intake of study treatment to starting no later than 28 days after study treatment discontinuation, at least every month | 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 | Time to Progression Free Survival (PFS) Per Central Radiology Review (Stratum 1) | from randomisation to dates of disease progression, death from any cause or last tumor assessment, reported between day of first patient randomised, 26 June 2006, until cut-off date 13 September 2010 | Progression free survival (PFS) is defined as the time from randomization to the date of first documented disease progression or death from any cause. The Kaplan-Meier estimate of the PFS survival function was constructed. Median PFS was obtained and displayed along with 95% confidence intervals. |
| Secondary | Time to Progression Free Survival (PFS) Per Central Radiology Review (Stratum 2) | from randomisation to dates of disease progression, death from any cause or last tumor assessment, reported between day of first patient randomised, 26 June 2006, until cut-off date 13 September 2010 | Progression free survival (PFS) is defined as the time from randomization to the date of first documented disease progression or death from any cause. The Kaplan-Meier estimate of the PFS survival function was constructed. Median PFS was obtained and displayed along with 95% confidence intervals. |
| Secondary | Time to Overall Survival (OS)(Stratum 1) | from randomisation to dates of disease progression, death from any cause, reported between day of first patient randomised, 26 June 2006, until cut-off date 13 April 2012 | Overall survival measures the time of survival , with any response or disease progression, until death. The OS is defined as the time from date of start of treatment to date of death due to any cause. If a patient is not known to have died, survival was censored at the date of last contact. In each treatment stratum, the Kaplan-Meier estimate of the overall survival function was constructed. |
| Secondary | Time to Overall Survival (OS) (Stratum 2) | from randomisation to dates of disease progression, death from any cause, reported between day of first patient randomised, 26 June 2006, until cut-off date 13 April 2012 | Overall survival measures the time of survival , with any response or disease progression, until death. The OS is defined as the time from date of start of treatment to date of death due to any cause. If a patient is not known to have died, survival was censored at the date of last contact. In each treatment stratum, the Kaplan-Meier estimate of the overall survival function was constructed. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Objective Response Rate: Percentage of Participants With Best Over All Response of Complete Response or Partial Response by Central Radiology Review (Stratum 1) Based on Response Evaluation Criteria in Solid Tumors (RECIST) | from date of randomization/start of treatment until first documented response confirmed 4 weeks later( at least 3 months) | The full analysis set (FAS) consisted of all patients who received at least one dose of everolimus. | percentage of participants | NUMBER |
| SECONDARY | Duration of Overall Response (Stratum 1) Based on Response Evaluation Criteria in Solid Tumors (RECIST)- Central Radiology Review | from date of first documented confirmed response to time to progression, at least 3 months | Full Analysis Set (FAS) consisted of all patients who received at least one dose of everolimus. Only those patients whose best overall response was complete response (CR) or partial response (PR) were included in this analysis. | Months | MEDIAN |
| SECONDARY | Duration of Overall Response (Stratum 2) Based on Response Evaluation Criteria in Solid Tumors (RECIST)- Central Radiology Review | from date of first documented confirmed response to time to progression, at least 3 months | Very low number of patients demonstrated a partial response, the median duration of response as per central review has not been calculated. | ||
| SECONDARY | Objective Response Rate: Percentage of Participants With Best Over All Response of Complete Response or Partial Response by Central Radiology Review (Stratum 2) Based on Response Evaluation Criteria in Solid Tumors (RECIST) | from date of randomization/start of treatment until first documented response confirmed 4 weeks later (at least 3 months) | Full Analysis Set (FAS) was consisted of all patients who received at least one dose of everolimus. | percentage of participants | NUMBER |
| SECONDARY | Number of Participants With Adverse Events (AEs), Death, Serious Adverse Events (SAEs)[Stratum 1] | on or after the day of the first intake of study treatment to starting no later than 28 days after study treatment discontinuation, at least every month | The safety population consists of all patients who received at least one dose of everolimus and had at least one post-baseline safety assessment. | Participants | NUMBER |
| SECONDARY | Number of Participants With Adverse Events (AEs), Death, Serious Adverse Events (SAEs) [Stratum 2] | on or after the day of the first intake of study treatment to starting no later than 28 days after study treatment discontinuation, at least every month | The safety population consists of all patients who received at least one dose of everolimus and had at least one post-baseline safety assessment. | Participants | NUMBER |
| SECONDARY | Time to Progression Free Survival (PFS) Per Central Radiology Review (Stratum 1) | from randomisation to dates of disease progression, death from any cause or last tumor assessment, reported between day of first patient randomised, 26 June 2006, until cut-off date 13 September 2010 | The full analysis set (FAS) consisted of all patients who received at least one dose of everolimus. | Months | MEDIAN |
| SECONDARY | Time to Progression Free Survival (PFS) Per Central Radiology Review (Stratum 2) | from randomisation to dates of disease progression, death from any cause or last tumor assessment, reported between day of first patient randomised, 26 June 2006, until cut-off date 13 September 2010 | The full analysis set (FAS) consisted of all patients who received at least one dose of everolimus. | Months | MEDIAN |
| SECONDARY | Time to Overall Survival (OS)(Stratum 1) | from randomisation to dates of disease progression, death from any cause, reported between day of first patient randomised, 26 June 2006, until cut-off date 13 April 2012 | The full analysis set consisted of all patients who received at least one dose of everolimus. | months | MEDIAN |
| SECONDARY | Time to Overall Survival (OS) (Stratum 2) | from randomisation to dates of disease progression, death from any cause, reported between day of first patient randomised, 26 June 2006, until cut-off date 13 April 2012 | The full analysis set consisted of all patients who received at least one dose of everolimus. | months | MEDIAN |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group17
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
Objective Response Rate: Percentage of Participants With Best Over All Response of Complete Response or Partial Response by Central Radiology Review (Stratum 1) Based on Response Evaluation Criteria in Solid Tumors (RECIST) | Stratum 1: Everolimus 10 mg | 9.6 | 95% Confidence Interval 4.9 to 16.5 | percentage of participants | |
| Duration of Overall Response (Stratum 1) Based on Response Evaluation Criteria in Solid Tumors (RECIST)- Central Radiology Review | Stratum 1: Everolimus 10 mg | 10.64 | 95% Confidence Interval 9.79 to NA | Months | |
Objective Response Rate: Percentage of Participants With Best Over All Response of Complete Response or Partial Response by Central Radiology Review (Stratum 2) Based on Response Evaluation Criteria in Solid Tumors (RECIST) | Stratum 2: Everolimus 10 mg + Octreotide Depot | 4.4 | 95% Confidence Interval 0.5 to 15.1 | percentage of participants | |
| Number of Participants With Adverse Events (AEs), Death, Serious Adverse Events (SAEs)[Stratum 1] | Stratum 1: Everolimus 10 mg | Adverse Events | 115 | Participants | |
| Number of Participants With Adverse Events (AEs), Death, Serious Adverse Events (SAEs)[Stratum 1] | Stratum 1: Everolimus 10 mg | Death | 10 | Participants | |
| Number of Participants With Adverse Events (AEs), Death, Serious Adverse Events (SAEs)[Stratum 1] | Stratum 1: Everolimus 10 mg | Serious Adverse Events | 63 | Participants | |
| Number of Participants With Adverse Events (AEs), Death, Serious Adverse Events (SAEs) [Stratum 2] | Stratum 2: Everolimus 10 mg + Octreotide Depot | Adverse Events | 45 | Participants | |
| Number of Participants With Adverse Events (AEs), Death, Serious Adverse Events (SAEs) [Stratum 2] | Stratum 2: Everolimus 10 mg + Octreotide Depot | Death | 2 | Participants | |
| Number of Participants With Adverse Events (AEs), Death, Serious Adverse Events (SAEs) [Stratum 2] | Stratum 2: Everolimus 10 mg + Octreotide Depot | Serious Adverse Events | 27 | Participants | |
| Time to Progression Free Survival (PFS) Per Central Radiology Review (Stratum 1) | Stratum 1: Everolimus 10 mg | 9.69 | 95% Confidence Interval 8.25 to 13.31 | Months |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Stratum 1: Everolimus 10 mg | 115 | |
| Overall Study | STARTED | Stratum 2: Everolimus 10 mg + Octreotide Depot | 45 | |
| Overall Study | COMPLETED | Stratum 1: Everolimus 10 mg | 77 | |
| Overall Study | COMPLETED | Stratum 2: Everolimus 10 mg + Octreotide Depot | 23 | |
| Overall Study | NOT COMPLETED | Stratum 1: Everolimus 10 mg | 38 | |
| Overall Study | NOT COMPLETED | Stratum 2: Everolimus 10 mg + Octreotide Depot | 22 |
Source ClinicalTrials.gov
Adverse events460
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 | Stratum 1: Everolimus 10 mg | 22 | 115 | |
| other | Anaemia | Blood and lymphatic system disorders | Stratum 2: Everolimus 10 mg + Octreotide Depot | 11 | 45 | |
| other | Leukopenia | Blood and lymphatic system disorders | Stratum 1: Everolimus 10 mg | 10 | 115 | |
| other | Leukopenia | Blood and lymphatic system disorders | Stratum 2: Everolimus 10 mg + Octreotide Depot | 2 | 45 | |
| other | Lymphopenia | Blood and lymphatic system disorders | Stratum 1: Everolimus 10 mg | 10 | 115 | |
| other | Lymphopenia | Blood and lymphatic system disorders | Stratum 2: Everolimus 10 mg + Octreotide Depot | 0 | 45 | |
| other | Neutropenia | Blood and lymphatic system disorders | Stratum 1: Everolimus 10 mg | 10 | 115 | |
| other | Neutropenia | Blood and lymphatic system disorders | Stratum 2: Everolimus 10 mg + Octreotide Depot | 5 | 45 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Stratum 1: Everolimus 10 mg | 11 | 115 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Stratum 2: Everolimus 10 mg + Octreotide Depot | 6 | 45 |
1 to 10 of 460Source ClinicalTrials.gov
See all 460 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Stratum 1: Everolimus 10 mg | ||
| Total, all-cause mortality | Stratum 2: Everolimus 10 mg + Octreotide Depot | ||
| Total, other adverse events | Stratum 1: Everolimus 10 mg | 115 | 115 |
| Total, other adverse events | Stratum 2: Everolimus 10 mg + Octreotide Depot | 44 | 45 |
| Total, serious adverse events | Stratum 1: Everolimus 10 mg | 63 | 115 |
| Total, serious adverse events | Stratum 2: Everolimus 10 mg + Octreotide Depot | 27 | 45 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Stratum 1: Everolimus 10 mg vs Stratum 2: Everolimus 10 mg + Octreotide Depot: serious adverse events |
Source Trial comparisons
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/NCT00363051
GET https://conductscience.org/api/trials/v1/NCT00363051/events?page=2