Trial · NCT01658436

BEZ235 Phase II Trial in Patients With Advanced Pancreatic Neuroendocrine Tumors (pNET) After Failure of mTOR Inhibitor Therapy.

NCT01658436, Phase 2, Completed, Novartis Pharmaceuticals; results first posted 2016-05-02

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. BEZ235 Phase II Trial in Patients With Advanced Pancreatic Neuroendocrine Tumors (pNET) After Failure of mTOR Inhibitor Therapy. Trials, record NCT01658436. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01658436

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: BEZ235 Phase II Trial in Patients With Advanced Pancreatic Neuroendocrine Tumors (pNET) After Failure of mTOR Inhibitor Therapy.
NCT number: NCT01658436
Status: Completed
Phases: Phase 2
Enrollment: 31 participants, actual
Lead sponsor: Novartis Pharmaceuticals
Conditions: Pancreatic Neuroendocrine Tumors (pNET)
Interventions: BEZ235 (Stage 1)
First posted: 2012-08-07
Last updated: 2016-05-02
Other registries' IDs: eudract:2012-000675-16
Results first posted: 2016-05-02

Source ClinicalTrials.gov

Registered outcomes3

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Stage 1 - Progression Free Survival (PFS) Rate Analysis at 16 Weeks as Per Local Radiology Review	16 weeks after the first BEZ235 administration.	PFS rate at 16 weeks was defined as a binary variable. Patients were considered as 'progression free' after 16 weeks if they had an overall lesion response of complete response (CR) partial response ('PR) or stable disease (SD)' and "progressed" if they had an overall lesion response of 'Progressive disease (PD) at the scan which occurred on day 105 after start of treatment, or later. Patients whose 16 weeks tumor assessment was unknown, missing or outside the window was not considered as 'progression free' and was considered a "failure" and counted only in the denominator for the estimation of the 16 week progression free rate.
Secondary	Stage 1- Overall Response Rate (ORR)	Baseline, every 8 weeks up to 31 months	Overall Response rate was defined as the proportion of patients with a best overall response of complete response or partial response, based on investigator's assessment as per RECIST criteria version 1.1. Based on futility analysis conducted at the end of stage 1, stage 2 was not initiated.
Secondary	Stage 1 - Disease Control Rate	Baseline, every 8 weeks up to 31 months	Disease control rate was defined as the proportion of patients with a best overall response of Complete Response, Partial response, or Stable disease, based on the investigator's assessment per RECIST version 1.1. Based on futility analysis conducted at the end of stage 1, stage 2 was not initiated.

Source ClinicalTrials.gov

Outcomes3

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Stage 1 - Progression Free Survival (PFS) Rate Analysis at 16 Weeks as Per Local Radiology Review	16 weeks after the first BEZ235 administration.	The Full Analysis Set (FAS) comprised of all patients who received at least one dose of study treatment (Stage 1). This set was known as 'Analysis Set Stage 1' (AS1).	Percentage of participants	NUMBER
SECONDARY	Stage 1- Overall Response Rate (ORR)	Baseline, every 8 weeks up to 31 months	The Full Analysis Set (FAS) comprised of all patients who received at least one dose of study treatment (Stage 1). This set was known as 'Analysis Set Stage 1' (AS1).	Percentage of participants	NUMBER
SECONDARY	Stage 1 - Disease Control Rate	Baseline, every 8 weeks up to 31 months	The Full Analysis Set (FAS) comprised of all patients who received at least one dose of study treatment (Stage 1). This set was known as 'Analysis Set Stage 1' (AS1).	Percentage of participants	NUMBER

Source ClinicalTrials.gov

Results by group4

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Stage 1 - Progression Free Survival (PFS) Rate Analysis at 16 Weeks as Per Local Radiology Review	BEZ235 300 mg/400 mg Bid		51.6	95% Confidence Interval 35.7 to 67.3	Percentage of participants
Stage 1- Overall Response Rate (ORR)	BEZ235 300 mg/400 mg Bid	Complete response	0.0		Percentage of participants
Stage 1- Overall Response Rate (ORR)	BEZ235 300 mg/400 mg Bid	Partial response	0.0		Percentage of participants
Stage 1 - Disease Control Rate	BEZ235 300 mg/400 mg Bid		71.0	95% Confidence Interval 54.8 to 83.9	Percentage of participants

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	BEZ235 300 mg	20
Overall Study	STARTED	BEZ235 400 mg Bid	11
Overall Study	COMPLETED	BEZ235 300 mg	0
Overall Study	COMPLETED	BEZ235 400 mg Bid	0
Overall Study	NOT COMPLETED	BEZ235 300 mg	20
Overall Study	NOT COMPLETED	BEZ235 400 mg Bid	11

Source ClinicalTrials.gov

Adverse events320

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
other	ANAEMIA	Blood and lymphatic system disorders	BEZ235 300 mg Bid	0	20
other	ANAEMIA	Blood and lymphatic system disorders	BEZ235 400 mg Bid	1	11
other	LYMPHOPENIA	Blood and lymphatic system disorders	BEZ235 300 mg Bid	1	20
other	LYMPHOPENIA	Blood and lymphatic system disorders	BEZ235 400 mg Bid	0	11
other	NEUTROPENIA	Blood and lymphatic system disorders	BEZ235 300 mg Bid	0	20
other	NEUTROPENIA	Blood and lymphatic system disorders	BEZ235 400 mg Bid	2	11
other	THROMBOCYTOPENIA	Blood and lymphatic system disorders	BEZ235 300 mg Bid	0	20
other	THROMBOCYTOPENIA	Blood and lymphatic system disorders	BEZ235 400 mg Bid	1	11
other	ATRIAL FIBRILLATION	Cardiac disorders	BEZ235 300 mg Bid	1	20
other	ATRIAL FIBRILLATION	Cardiac disorders	BEZ235 400 mg Bid	0	11

1 to 10 of 320Source ClinicalTrials.gov

See all 320 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	BEZ235 300 mg Bid
Total, all-cause mortality	BEZ235 400 mg Bid
Total, other adverse events	BEZ235 300 mg Bid	20	20
Total, other adverse events	BEZ235 400 mg Bid	11	11
Total, serious adverse events	BEZ235 300 mg Bid	8	20
Total, serious adverse events	BEZ235 400 mg Bid	5	11

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
26851029	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 300 mg Bid vs BEZ235 400 mg Bid: 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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT01658436

GET https://conductscience.org/api/trials/v1/NCT01658436/events?page=2

API reference For AI assistants