Trial · NCT01374451
Efficacy of Everolimus Alone or in Combination With Pasireotide LAR in Advanced PNET
NCT01374451, Phase 2, Terminated, Novartis Pharmaceuticals; results first posted 2016-12-20
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Efficacy of Everolimus Alone or in Combination With Pasireotide LAR in Advanced PNET. Trials, record NCT01374451. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01374451
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy of Everolimus Alone or in Combination With Pasireotide LAR in Advanced PNET
- NCT number
- NCT01374451
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 160 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Islet Cell Tumor
- Interventions
- Everolimus, Pasireotide LAR
- First posted
- 2011-06-16
- Last updated
- 2016-12-20
- Other registries' IDs
- eudract:2010-023183-40
- Results first posted
- 2016-12-20
- Limitations and caveats
A planned primary analysis was completed with data cut of 02-Apr-2014. The study did not meet its primary objective, which was based on progression-free survival as per local radiology assessment and was prematurely terminated.
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-free Survival (PFS) Per Local Radiological Review | Once 80 PFS events had occurred aproximately after 24 months | PFS per RECIST 1.0. (Response Evaluation Criteria in Solid Tumors). PFS was defined as the time from the date of randomization to the date of the first radiologically documented disease progression or death due to any cause. |
| Secondary | Safety and Tolerability Profile of Everolimus Alone or in Combination With Pasireotide LAR | Once 80 PFS events had occurred | Consisted of monitoring and recording the rate, type, severity, and causal relationship of adverse events (AEs) and serious AEs (SAEs) to treatment. The safety analysis was based mainly on the frequency of AEs or SAEs and on the number of laboratory values that fell outside of pre-determined range. |
| Secondary | Objective Response Rate (ORR) as Per Radiology Review | Once 80 PFS events had occurred | Objective response was determined by the local radiologist according to the RECIST Version 1.0. ORR is the percentage of patients with a best overall response of complete response (CR) or partial response (PR). This is also referred to as Overall response rate. CR: Disappearance of all nontarget lesions. PR: At least a 30% decrease in the sum of the longest diameter of all target lesions, taking as reference the smallest sum of the longest diameter of all target lesions recorded at or after baseline. |
| Secondary | Duration of Response (DoR) | Once 80 PFS events had occurred | 80 PFS are expected after approximately 24 months. Kaplan Meier was initially planned to be used to depict duration of response by treatment group and by stratum. Later based on the mode of action of everolimus and pasireotide and based on study experience, only a low number of objective responses per RECIST were expected. Therefore, protocol was amended to only list duration of response, and confirmed responses were flagged in the listing. Hence, statistical analyses were not planned and such data are not available for the following table. |
| Secondary | Overall Survival (OS) Using Kaplan Meier Method | Once 80 PFS events had occurred | Overall survival was defined as the time from date of randomization/start of treatment to date of death due to any cause. If a patient is not known to have died, survival was to be censored at the date of last contact. |
| Secondary | PFS and the Predictive Probability of Success in Phase III | Once 105 PFS events had occurred occurred | 105 PFS events expected after approximately 36 months |
| Secondary | Disease Control Rate (DCR) as Per Radiology Review | Once 80 PFS events had occurred | Disease control rate is the percentage of patients with a best overall response of CR or PR or stable disease (SD) determined by the local radiologist according to the Response Evaluation Criteria In Solid Tumors Criteria (RECIST) Version 1.0. CR: Disappearance of all nontarget lesions. PR: At least a 30% decrease in the sum of the longest diameter of all target lesions, taking as reference the smallest sum of the longest diameter of all target lesions recorded at or after baseline. SD: Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for progressive disease (PD). PD: Any progression ≤ 18 weeks after randomization (and not qualifying for CR, PR or stable disease SD. |
| Secondary | Summary of Pharmacokinetics (PK) for Everolimus for AUClast | Cycle 2 Day 1 | |
| Secondary | Summary of Pharmacokinetics (PK) for Everolimus for CL/F | Cycle 2 Day 1 | |
| Secondary | Summary of Pharmacokinetics (PK) for Everolimus for Cmax and Cmin | Cycle 2 Day 1 |
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 | Progression-free Survival (PFS) Per Local Radiological Review | Once 80 PFS events had occurred aproximately after 24 months | The FAS consisted of all randomized patients. Following the intention to treat principle patients were analyzed according to the treatment (and stratum) they were assigned to at randomization.~One patient in the everolimus + pasireotide LAR treatment arm was untreated due to administrative problems. | months | MEDIAN |
| SECONDARY | Safety and Tolerability Profile of Everolimus Alone or in Combination With Pasireotide LAR | Once 80 PFS events had occurred | Safety analysis population included all patients who received any study medication (i.e. at least 1 dose of the study drug in case of monotherapy or at least 1 dose of any 1 compound of the study treatment in case of a combination therapy) with a post-Baseline safety assessment.~See Adverse Events (AE) section for all AEs collected. | Participants | NUMBER |
| SECONDARY | Objective Response Rate (ORR) as Per Radiology Review | Once 80 PFS events had occurred | The FAS consisted of all randomized patients.1 patient in the everolimus + pasireotide LAR treatment arm was untreated due to administrative problems. The study was terminated because the study did not meet its primary objective so minimal efficacy data was obtained. | Percentage of participants | NUMBER |
| SECONDARY | Duration of Response (DoR) | Once 80 PFS events had occurred | The FAS consisted of all randomized patients. Only a low number of objective responses per RECIST was expected. Therefore, protocol was amended to only list duration of response, and confirmed responses were flagged in the listing. Hence, statistical analyses were not planned and such data are not available for the following table. | ||
| SECONDARY | Overall Survival (OS) Using Kaplan Meier Method | Once 80 PFS events had occurred | The FAS consisted of all randomized patients.1 patient in the everolimus + pasireotide LAR treatment arm was untreated due to administrative problems. The study was terminated because the study did not meet its primary objective so minimal efficacy data was obtained. | Percentage of participants | NUMBER |
| SECONDARY | PFS and the Predictive Probability of Success in Phase III | Once 105 PFS events had occurred occurred | Since the study was terminated because the study did not meet its primary objective which was based on PFS as per local radiology assessment, minimal efficacy data was obtained. Only 80 PFS events occurred before study was terminated so 105 PFS events was not reached to analyze this data. | ||
| SECONDARY | Disease Control Rate (DCR) as Per Radiology Review | Once 80 PFS events had occurred | The FAS consisted of all randomized patients.1 patient in the everolimus + pasireotide LAR treatment arm was untreated due to administrative problems. The study was terminated because the study did not meet its primary objective so minimal efficacy data was obtained. | Percentage of participants | NUMBER |
| SECONDARY | Summary of Pharmacokinetics (PK) for Everolimus for AUClast | Cycle 2 Day 1 | PK analysis set consisted of all patients who had at least 1 pasireotide LAR injection or 1 everolimus administration and 1 evaluable concentration data. | ng*hr/mL | MEAN |
| SECONDARY | Summary of Pharmacokinetics (PK) for Everolimus for CL/F | Cycle 2 Day 1 | PK analysis set consisted of all patients who had at least 1 pasireotide LAR injection or 1 everolimus administration and 1 evaluable concentration data. | L/hr | MEAN |
| SECONDARY | Summary of Pharmacokinetics (PK) for Everolimus for Cmax and Cmin | Cycle 2 Day 1 | PK analysis set consisted of all patients who had at least 1 pasireotide LAR injection or 1 everolimus administration and 1 evaluable concentration data. | ng/mL | MEAN |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults 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) Per Local Radiological Review | Paseriotide LAR + Everolimus | 16.82 | 95% Confidence Interval 12.09 to 19.58 | months | |
| Progression-free Survival (PFS) Per Local Radiological Review | Everolimus | 16.59 | 95% Confidence Interval 11.07 to 19.48 | months | |
| Safety and Tolerability Profile of Everolimus Alone or in Combination With Pasireotide LAR | Paseriotide LAR + Everolimus | Deaths | 7 | Participants | |
| Safety and Tolerability Profile of Everolimus Alone or in Combination With Pasireotide LAR | Everolimus | Deaths | 10 | Participants | |
| Safety and Tolerability Profile of Everolimus Alone or in Combination With Pasireotide LAR | Paseriotide LAR + Everolimus | Serious Adverse Events | 41 | Participants | |
| Safety and Tolerability Profile of Everolimus Alone or in Combination With Pasireotide LAR | Everolimus | Serious Adverse Events | 49 | Participants | |
| Safety and Tolerability Profile of Everolimus Alone or in Combination With Pasireotide LAR | Paseriotide LAR + Everolimus | Adverse Events | 78 | Participants | |
| Safety and Tolerability Profile of Everolimus Alone or in Combination With Pasireotide LAR | Everolimus | Adverse Events | 81 | Participants | |
| Objective Response Rate (ORR) as Per Radiology Review | Paseriotide LAR + Everolimus | 20.3 | 95% Confidence Interval 12.0 to 30.8 | Percentage of participants | |
| Objective Response Rate (ORR) as Per Radiology Review | Everolimus | 6.2 | 95% Confidence Interval 2.0 to 13.8 | Percentage of participants |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Paseriotide LAR + Everolimus | 79 | |
| Overall Study | STARTED | Everolimus | 81 | |
| Overall Study | COMPLETED | Paseriotide LAR + Everolimus | 78 | |
| Overall Study | COMPLETED | Everolimus | 81 | |
| Overall Study | NOT COMPLETED | Paseriotide LAR + Everolimus | 1 | |
| Overall Study | NOT COMPLETED | Everolimus | 0 |
Source ClinicalTrials.gov
Adverse events432
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 LAR + Pasireotide | 21 | 78 | |
| other | Anaemia | Blood and lymphatic system disorders | Everolimus | 20 | 81 | |
| other | Leukopenia | Blood and lymphatic system disorders | Everolimus LAR + Pasireotide | 3 | 78 | |
| other | Leukopenia | Blood and lymphatic system disorders | Everolimus | 7 | 81 | |
| other | Lymphopenia | Blood and lymphatic system disorders | Everolimus LAR + Pasireotide | 4 | 78 | |
| other | Lymphopenia | Blood and lymphatic system disorders | Everolimus | 4 | 81 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Everolimus LAR + Pasireotide | 8 | 78 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Everolimus | 9 | 81 | |
| other | Abdominal distension | Gastrointestinal disorders | Everolimus LAR + Pasireotide | 7 | 78 | |
| other | Abdominal distension | Gastrointestinal disorders | Everolimus | 8 | 81 |
1 to 10 of 432Source ClinicalTrials.gov
See all 432 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Everolimus LAR + Pasireotide | ||
| Total, all-cause mortality | Everolimus | ||
| Total, other adverse events | Everolimus LAR + Pasireotide | 77 | 78 |
| Total, other adverse events | Everolimus | 80 | 81 |
| Total, serious adverse events | Everolimus LAR + Pasireotide | 41 | 78 |
| Total, serious adverse events | Everolimus | 49 | 81 |
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 |
|---|
| Everolimus LAR + Pasireotide vs Everolimus: 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/NCT01374451
GET https://conductscience.org/api/trials/v1/NCT01374451/results?page=2