Trial · NCT01628913
Efficacy and Safety of BEZ235 Compared to Everolimus in Patients With Advanced Pancreatic Neuroendocrine Tumors
NCT01628913, Phase 2, Terminated, Novartis Pharmaceuticals; results first posted 2016-04-07
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Efficacy and Safety of BEZ235 Compared to Everolimus in Patients With Advanced Pancreatic Neuroendocrine Tumors. Trials, record NCT01628913. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01628913
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of BEZ235 Compared to Everolimus in Patients With Advanced Pancreatic Neuroendocrine Tumors
- NCT number
- NCT01628913
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 62 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Pancreatic Neuroendocrine Tumors (pNET)
- Interventions
- BEZ235, Everolimus
- First posted
- 2012-06-27
- Last updated
- 2016-04-07
- Results first posted
- 2016-04-07
- Limitations and caveats
Trial terminated based on the results of a pre-planned interim analysis of the primary OM ( which demonstrated BEX235 not having improved PFS (progression free survival) vs everolimus)..The secondary OM analyses were not conducted
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression Free Survival (PFS) | up to approx. 18 months | PFS is defined as the time from the date of randomization until the date of the first radiologically documented disease progression or death due to any cause. PFS is based on local investigator assessment. Patients will be followed up for the duration of the study and for an expected average of every 12 weeks after randomization. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of all target lesions, or unequivocal progression of non-target lesions, or the appearance of new lesions. |
| Secondary | Objective Response Rate | up to approx. 18 months | Proportion of patients with a best overall response during the study of complete response (CR) or partial response (PR), based on the investigator assessment. 2. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for all target and non-target lesions, as well as new lesions as assessed by CT or MRI: Complete Response (CR), Disappearance of all target and non-target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of all target lesions; Overall Response (OR) = CR + PR. |
| Secondary | Overall Survival (OS) | up to approx. 30 months | Time from randomization to the date of death due to any cause |
| Secondary | Time to Treatment Failure (TTF) | up to approx. 18 months | Time from randomization to the date of the first of the following events:death due to any cause or progressive disease, treatment discontinuation due to toxicity or treatment discontinuation due to patient preference |
Source ClinicalTrials.gov
Outcomes4
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) | up to approx. 18 months | Full analysis set: The Full analysis set (FAS) comprised all patients who were randomized to study treatment. According to the intent to treat principle, patient was analyzed according to the treatment and strata they had been assigned to during the randomization procedure. | Months | MEDIAN |
| SECONDARY | Objective Response Rate | up to approx. 18 months | Trial terminated based on the results of an interim analysis of the primary OM ( which demonstrated BEX235 not having improved PFS (progression free survival) vs everolimus).The secondary OM analyses were not conducted. | ||
| SECONDARY | Overall Survival (OS) | up to approx. 30 months | Trial terminated based on the results of an interim analysis of the primary OM ( which demonstrated BEX235 not having improved PFS (progression free survival) vs everolimus).The secondary OM analyses were not conducted. | ||
| SECONDARY | Time to Treatment Failure (TTF) | up to approx. 18 months | Trial terminated based on the results of an interim analysis of the primary OM ( which demonstrated BEX235 not having improved PFS (progression free survival) vs everolimus).The secondary OM analyses were not conducted. |
Source ClinicalTrials.gov
Results by group2
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) | BEZ235 | 8.2 | 95% Confidence Interval 5.3 to NA | Months | |
| Progression Free Survival (PFS) | Everolimus | 10.8 | 95% Confidence Interval 8.1 to NA | Months |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | BEZ235 | 31 | |
| Overall Study | STARTED | Everolimus | 31 | |
| Overall Study | COMPLETED | BEZ235 | 0 | |
| Overall Study | COMPLETED | Everolimus | 0 | |
| Overall Study | NOT COMPLETED | BEZ235 | 31 | |
| Overall Study | NOT COMPLETED | Everolimus | 31 |
Source ClinicalTrials.gov
Adverse events254
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 | BEZ235 | 8 | 31 | |
| other | Anaemia | Blood and lymphatic system disorders | Everolimus | 11 | 31 | |
| other | Leukocytosis | Blood and lymphatic system disorders | BEZ235 | 2 | 31 | |
| other | Leukocytosis | Blood and lymphatic system disorders | Everolimus | 0 | 31 | |
| other | Neutropenia | Blood and lymphatic system disorders | BEZ235 | 2 | 31 | |
| other | Neutropenia | Blood and lymphatic system disorders | Everolimus | 2 | 31 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | BEZ235 | 2 | 31 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Everolimus | 4 | 31 | |
| other | Palpitations | Cardiac disorders | BEZ235 | 2 | 31 | |
| other | Palpitations | Cardiac disorders | Everolimus | 1 | 31 |
1 to 10 of 254Source ClinicalTrials.gov
See all 254 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | BEZ235 | ||
| Total, all-cause mortality | Everolimus | ||
| Total, other adverse events | BEZ235 | 31 | 31 |
| Total, other adverse events | Everolimus | 30 | 31 |
| Total, serious adverse events | BEZ235 | 11 | 31 |
| Total, serious adverse events | Everolimus | 9 | 31 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 29242283 | 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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| BEZ235 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/NCT01628913
GET https://conductscience.org/api/trials/v1/NCT01628913/events?page=2