Trial · NCT00412061
Everolimus and Octreotide in Patients With Advanced Carcinoid Tumor
NCT00412061, Phase 3, Completed, Novartis Pharmaceuticals; results first posted 2012-03-12
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Everolimus and Octreotide in Patients With Advanced Carcinoid Tumor. Trials, record NCT00412061. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00412061
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Everolimus and Octreotide in Patients With Advanced Carcinoid Tumor
- NCT number
- NCT00412061
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 429 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Carcinoid Tumor, Malignant Carcinoid Syndrome
- Interventions
- Octreotide, Placebo, Everolimus
- First posted
- 2006-12-15
- Last updated
- 2014-11-21
- Other registries' IDs
- eudract:2006-004507-18
- Results first posted
- 2012-03-12
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression Free Survival (PFS) as Per Adjudicated Central Radiology Review | Time from randomisation to dates of disease progression, death from any cause or last tumor assessment, reported between day of first patient randomised, 10 January 2007, until cut-off date 02 April 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 primary analysis of PFS was based on the independent central adjudicated assessment using Kaplan-Meier method. |
| Secondary | Best Overall Response Rate as Per Adjudicated Central Radiology Review Based on Response Evaluation Criteria in Solid Tumors (RECIST) | Time from randomisation to dates of disease progression, death from any cause or last tumor assessment, reported between day of first patient randomised, 10 January 2007, until cut-off date 02 April 2010 | The best overall response rate is defined as the percentage of patients having achieved confirmed Complete Response + Partial Response. 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. |
| Secondary | Progression Free Survival (PFS) as Per Adjudicated Central Review by Baseline 5-hydroxyindoleacetic Acid (5-HIAA) Level | If elevated at baseline, evaluated every cycle visit (28 days/cycle) reported between day of first patient randomised, 10 January 2007, until cut-off date 02 April 2010 | 5-HIAA levels in urine are frequently elevated in patients with advanced carcinoid tumors. Baseline levels of 5-HIAA in urine were defined as 'High' if they exceeded the median value, and 'Low' if they were lower than or equal to the median. |
| Secondary | Overall Survival Using Kaplan-Meier Methodology | Months 12, 24, 36, 48 | Overall survival was defined as the time from the date of randomization to the date of death from any cause. If a patient was not known to have died, survival was censored at the date of last contact. Kaplan-Meier methodology was used to estimate the median overall survival for each treatment group. |
| Secondary | Number of Patients With Adverse Events (AEs), Clinically Notable AE, Death, Serious Adverse Events (SAEs) (Double-Blind Phase) | From first day of treatment up to 28 days after last day of treatment in double blind | AEs 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. SAEs 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 Patients With Adverse Events (AEs), Clinically Notable AE, Death, Serious Adverse Events (SAEs) (Open Label Phase) | From first day of treatment up to 28 days after last day of treatment in double blind | AEs 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. SAEs 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 | Progression Free Survival (PFS) as Per Adjudicated Central Review by Baseline Chromogranin A (CgA) | If elevated at baseline, evaluated every cycle visit (28 days/cycle) reported between day of first patient randomised, 10 January 2007, until cut-off date 02 April 2010 | Serum CgA levels in urine are frequently elevated in patients with advanced carcinoid tumors. Baseline levels of serum CgA were characterized relative to the upper limited of normal (ULN). CgA levels exceeding 2 x ULN were considered to be 'Elevated'; otherwise considered as "Non-elevated". |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression Free Survival (PFS) as Per Adjudicated Central Radiology Review | Time from randomisation to dates of disease progression, death from any cause or last tumor assessment, reported between day of first patient randomised, 10 January 2007, until cut-off date 02 April 2010 | The Full Analysis Set (FAS) consisted of all randomized patients. | Months | MEDIAN |
| SECONDARY | Best Overall Response Rate as Per Adjudicated Central Radiology Review Based on Response Evaluation Criteria in Solid Tumors (RECIST) | Time from randomisation to dates of disease progression, death from any cause or last tumor assessment, reported between day of first patient randomised, 10 January 2007, until cut-off date 02 April 2010 | The Full Analysis Set (FAS; Intent-to-treat Population) consists of all randomized patients. | Percentage of patients | NUMBER |
| SECONDARY | Progression Free Survival (PFS) as Per Adjudicated Central Review by Baseline 5-hydroxyindoleacetic Acid (5-HIAA) Level | If elevated at baseline, evaluated every cycle visit (28 days/cycle) reported between day of first patient randomised, 10 January 2007, until cut-off date 02 April 2010 | The Full Analysis Set (FAS; Intent-to-treat Population) consists of all randomized patients. This analysis includes PFS patients with non missing baseline 5-HIAA data. | Months | MEDIAN |
| SECONDARY | Overall Survival Using Kaplan-Meier Methodology | Months 12, 24, 36, 48 | The Full Analysis Set (FAS; Intent-to-treat Population) consists of all randomized patients. | Percentage of Participants | NUMBER |
| SECONDARY | Number of Patients With Adverse Events (AEs), Clinically Notable AE, Death, Serious Adverse Events (SAEs) (Double-Blind Phase) | From first day of treatment up to 28 days after last day of treatment in double blind | The Safety Set consists of all patients who received at least one dose of study drug and who had at least one valid post-baseline safety assessment. | Patients | NUMBER |
| SECONDARY | Number of Patients With Adverse Events (AEs), Clinically Notable AE, Death, Serious Adverse Events (SAEs) (Open Label Phase) | From first day of treatment up to 28 days after last day of treatment in double blind | The Safety Set consists of all patients who received at least one dose of study drug and who had at least one valid post-baseline safety assessment. | Patients | NUMBER |
| SECONDARY | Progression Free Survival (PFS) as Per Adjudicated Central Review by Baseline Chromogranin A (CgA) | If elevated at baseline, evaluated every cycle visit (28 days/cycle) reported between day of first patient randomised, 10 January 2007, until cut-off date 02 April 2010 | The Full Analysis Set (FAS; Intent-to-treat Population) consists of all randomized patients. This analysis includes PFS patients with non missing baseline CgA data. | Months | MEDIAN |
Source ClinicalTrials.gov
Results by group32
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression Free Survival (PFS) as Per Adjudicated Central Radiology Review | Octreotide+ Everolimus | 16.43 | 95% Confidence Interval 13.67 to 21.19 | Months | |
| Progression Free Survival (PFS) as Per Adjudicated Central Radiology Review | Octreotide+ Placebo | 11.33 | 95% Confidence Interval 8.44 to 14.59 | Months | |
| Best Overall Response Rate as Per Adjudicated Central Radiology Review Based on Response Evaluation Criteria in Solid Tumors (RECIST) | Octreotide+ Everolimus | 2.3 | 95% Confidence Interval 0.8 to 5.30 | Percentage of patients | |
| Best Overall Response Rate as Per Adjudicated Central Radiology Review Based on Response Evaluation Criteria in Solid Tumors (RECIST) | Octreotide+ Placebo | 1.9 | 95% Confidence Interval 0.5 to 4.7 | Percentage of patients | |
| Progression Free Survival (PFS) as Per Adjudicated Central Review by Baseline 5-hydroxyindoleacetic Acid (5-HIAA) Level | Octreotide+ Everolimus | 5-HIAA <=median (n=93,96) | 21.75 | 95% Confidence Interval 13.93 to NA | Months |
| Progression Free Survival (PFS) as Per Adjudicated Central Review by Baseline 5-hydroxyindoleacetic Acid (5-HIAA) Level | Octreotide+ Placebo | 5-HIAA <=median (n=93,96) | 13.90 | 95% Confidence Interval 8.71 to 22.44 | Months |
| Progression Free Survival (PFS) as Per Adjudicated Central Review by Baseline 5-hydroxyindoleacetic Acid (5-HIAA) Level | Octreotide+ Everolimus | 5-HIAA > median (n=94,95) | 13.83 | 95% Confidence Interval 10.61 to 18.63 | Months |
| Progression Free Survival (PFS) as Per Adjudicated Central Review by Baseline 5-hydroxyindoleacetic Acid (5-HIAA) Level | Octreotide+ Placebo | 5-HIAA > median (n=94,95) | 8.41 | 95% Confidence Interval 8.08 to 11.33 | Months |
| Overall Survival Using Kaplan-Meier Methodology | Octreotide+ Everolimus | 12 Months | 80.5 | 95% Confidence Interval 74.5 to 85.3 | Percentage of Participants |
| Overall Survival Using Kaplan-Meier Methodology | Octreotide+ Placebo Followed by Open Label Arm | 12 Months | 81.8 | 95% Confidence Interval 75.8 to 86.4 | Percentage of Participants |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 results by groupParticipant flow14
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Double Blind Phase | STARTED | Octreotide+ Everolimus | 216 | |
| Double Blind Phase | STARTED | Octreotide+ Placebo Followed by Open Label Arm | 213 | |
| Double Blind Phase | Safety Set | Octreotide+ Everolimus | 215 | |
| Double Blind Phase | Safety Set | Octreotide+ Placebo Followed by Open Label Arm | 211 | |
| Double Blind Phase | COMPLETED | Octreotide+ Everolimus | 0 | |
| Double Blind Phase | COMPLETED | Octreotide+ Placebo Followed by Open Label Arm | 0 | |
| Double Blind Phase | NOT COMPLETED | Octreotide+ Everolimus | 216 | |
| Double Blind Phase | NOT COMPLETED | Octreotide+ Placebo Followed by Open Label Arm | 213 | |
| Open Label Phase | STARTED | Octreotide+ Everolimus | 0 | |
| Open Label Phase | STARTED | Octreotide+ Placebo Followed by Open Label Arm | 170 |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 participant flowAdverse events1,062
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 + Octreotide | 58 | 215 | |
| other | Anaemia | Blood and lymphatic system disorders | Placebo + Octreotide | 21 | 211 | |
| other | Anaemia | Blood and lymphatic system disorders | Everolimus Open Label | 34 | 170 | |
| other | Leukopenia | Blood and lymphatic system disorders | Everolimus + Octreotide | 16 | 215 | |
| other | Leukopenia | Blood and lymphatic system disorders | Placebo + Octreotide | 2 | 211 | |
| other | Leukopenia | Blood and lymphatic system disorders | Everolimus Open Label | 2 | 170 | |
| other | Neutropenia | Blood and lymphatic system disorders | Everolimus + Octreotide | 18 | 215 | |
| other | Neutropenia | Blood and lymphatic system disorders | Placebo + Octreotide | 3 | 211 | |
| other | Neutropenia | Blood and lymphatic system disorders | Everolimus Open Label | 13 | 170 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Everolimus + Octreotide | 34 | 215 |
1 to 10 of 1,062Source ClinicalTrials.gov
See all 1,062 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Everolimus + Octreotide | ||
| Total, all-cause mortality | Placebo + Octreotide | ||
| Total, all-cause mortality | Everolimus Open Label | ||
| Total, other adverse events | Everolimus + Octreotide | 214 | 215 |
| Total, other adverse events | Placebo + Octreotide | 194 | 211 |
| Total, other adverse events | Everolimus Open Label | 162 | 170 |
| Total, serious adverse events | Everolimus + Octreotide | 126 | 215 |
| Total, serious adverse events | Placebo + Octreotide | 74 | 211 |
| Total, serious adverse events | Everolimus Open Label | 93 | 170 |
Source ClinicalTrials.gov
Papers3
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.
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/NCT00412061
GET https://conductscience.org/api/trials/v1/NCT00412061/results?page=2