Trial · NCT02246127

Sequentiality of Everolimus and STZ-5FU in Advanced Pancreatic Neuroendocrine Tumor

NCT02246127, Phase 3, Completed, Grupo Espanol de Tumores Neuroendocrinos; results first posted 2025-05-11

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Sequentiality of Everolimus and STZ-5FU in Advanced Pancreatic Neuroendocrine Tumor. Trials, record NCT02246127. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02246127

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Trial

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

Title: Sequentiality of Everolimus and STZ-5FU in Advanced Pancreatic Neuroendocrine Tumor
NCT number: NCT02246127
Status: Completed
Phases: Phase 3
Enrollment: 141 participants, actual
Lead sponsor: Grupo Espanol de Tumores Neuroendocrinos
Conditions: Neuroendocrine Tumors
Interventions: Drug: Everolimus, STZ-5FU
First posted: 2014-09-22
Last updated: 2025-05-11
Other registries' IDs: eudract:2013-000726-66
Results first posted: 2025-05-11

Source ClinicalTrials.gov

Registered outcomes13

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

List	Outcome	Time frame	Description
Primary	First Progression Free Survival (PFS1)	At 12 months	Proportion of patients who are alive without progression to Course 1 from the date of randomization in STZ based CT vs Everolimus arms Definitions for PFS rate for course 1 at 12 months: * No: number (proportion) of patients who were not alive and progression free according to the respective definition (main, conservative, and optimistic); * Yes: number (proportion) of patients who were alive and progression free according to the respective definition (main, conservative, and optimistic).
Secondary	Second Progression Free Survival (Second PFS)	Until the end of study every 12 weeks, approximately up to 5 years	PFS of Course 1 (PFS1) + interval between treatments + PFS of Course 2 (PFS2), where PFS1 represents progression free survival of Course 1 and PFS2 represents progression free survival of Course 2
Secondary	Progression-free Survival (PFS) to First Treatment	Throughout the study period every 12 weeks, approximately up to 5 years	Time from the date of randomization to the date of first disease progression.
Secondary	Adverse Events (AEs) Rate	Throughout the study period in continous monitoring at every visit for approximately up to 5 years	Number of patients expiriencing adverse events, treatment-related AEs and serious adverse events (SAEs)
Secondary	Frequency of Dose Modifications to First Treatment	Throughout the study period, approximately up to 5 years	Percentage of patients who require a dose reduction or interruption for management of adverse events during the study period
Secondary	Best Overall Response (BOR) to First Study Treatment	Throughout the study period, every 12 weeks up to approximately 5 years	Best response achieved with the first study treatment according to RECIST V1.0
Secondary	Objective Response Rate (ORR) to First Study Treatment	Throughout the study period every 12 weeks, up to approximately 5 years	The ORR is defined as the number of patients having as their BOR to first treatment either Complete response (CR) or Partial Response (PR) measured by RECIST criteria version 1.0.
Secondary	Frequency of Dose Modifications to Second Treatment	Throughout the study period, approximately up to 5 years	Percentage of patients who require a dose reduction or interruption for management of adverse events during the study period
Secondary	Overall Survival (OS)	Throughout the study period, up to approximately 5 years	The median OS defined as the time from the date of randomization until death from any cause. This is estimated by kaplan meier method.
Secondary	Best Overall Response (BOR) to Second Study Treatment	Throughout the study period, every 12 weeks up to approximately 5 years	Best response achieved with the second study treatment according to RECIST V1.0

1 to 10 of 13Source ClinicalTrials.gov

See all 13 registered outcomes

Outcomes13

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	First Progression Free Survival (PFS1)	At 12 months	Patients diagnosed advanced progressive pancreatic neuroendocrine tumours (pNETs)	percentage of patients alive and PD-free	NUMBER
SECONDARY	Second Progression Free Survival (Second PFS)	Until the end of study every 12 weeks, approximately up to 5 years	Patients diagnosed advanced progressive pancreatic neuroendocrine tumours (pNETs)	months	MEDIAN
SECONDARY	Progression-free Survival (PFS) to First Treatment	Throughout the study period every 12 weeks, approximately up to 5 years	Patients diagnosed advanced progressive pancreatic neuroendocrine tumours (pNETs)	months	MEDIAN
SECONDARY	Adverse Events (AEs) Rate	Throughout the study period in continous monitoring at every visit for approximately up to 5 years	Patients who do not received study treatment were not included in the safety population to analyze safety.~The outcome is reported per arm, as the trial was designed to report which sequential strategy is the best in overall. Most patients with panNETs progress and therefore will require to go through both treatments. The main scientific interest is the overall safety/efficacy.	Patients	NUMBER
SECONDARY	Frequency of Dose Modifications to First Treatment	Throughout the study period, approximately up to 5 years	Patients diagnosed advanced progressive pancreatic neuroendocrine tumours (pNETs) receiving study treatment.	Patients	NUMBER
SECONDARY	Best Overall Response (BOR) to First Study Treatment	Throughout the study period, every 12 weeks up to approximately 5 years	Patients diagnosed advanced progressive pancreatic neuroendocrine tumours (pNETs) receiving treatment.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Objective Response Rate (ORR) to First Study Treatment	Throughout the study period every 12 weeks, up to approximately 5 years	Patients diagnosed advanced progressive pancreatic neuroendocrine tumours (pNETs) receiving study treatment	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Frequency of Dose Modifications to Second Treatment	Throughout the study period, approximately up to 5 years	Patients diagnosed advanced progressive pancreatic neuroendocrine tumours (pNETs) receiving the second-line study treatment.	Patients	NUMBER
SECONDARY	Overall Survival (OS)	Throughout the study period, up to approximately 5 years	Intention to treat population. The outcome is reported per arm rather than intervention, as the trial was designed to demonstrate which sequential strategy is the best in overall. Most patients with panNETs progress and therefore will require to go through both treatments. The main scientific interest is the overall safety/efficacy.	months	MEDIAN
SECONDARY	Best Overall Response (BOR) to Second Study Treatment	Throughout the study period, every 12 weeks up to approximately 5 years	Patients diagnosed advanced progressive pancreatic neuroendocrine tumours (pNETs) receiving the second treatment.	Participants	COUNT_OF_PARTICIPANTS

1 to 10 of 13Source ClinicalTrials.gov

See all 13 outcomes

Results by group54

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

Outcome	Group	Category	Value	Spread	Units
First Progression Free Survival (PFS1)	Sequence A, Drug: Everolimus First		71.4	95% Confidence Interval 59.4 to 81.6	percentage of patients alive and PD-free
First Progression Free Survival (PFS1)	Sequence B, Drug: STZ - 5FU First		61.8	95% Confidence Interval 49.2 to 73.3	percentage of patients alive and PD-free
Second Progression Free Survival (Second PFS)	Sequence A, Drug: Everolimus First		37.5	95% Confidence Interval 27.1 to 53.7	months
Second Progression Free Survival (Second PFS)	Sequence B, Drug: STZ - 5FU First		32.6	95% Confidence Interval 23.7 to 41.1	months
Progression-free Survival (PFS) to First Treatment	Sequence A, Drug: Everolimus First		19.4	95% Confidence Interval 16.8 to 27.6	months
Progression-free Survival (PFS) to First Treatment	Sequence B, Drug: STZ - 5FU First		22.7	95% Confidence Interval 13.3 to 28.6	months
Adverse Events (AEs) Rate	Sequence A, Drug: Everolimus First	AEs	68		Patients
Adverse Events (AEs) Rate	Sequence B, Drug: STZ - 5FU First	AEs	62		Patients
Adverse Events (AEs) Rate	Sequence A, Drug: Everolimus First	SAEs	28		Patients
Adverse Events (AEs) Rate	Sequence B, Drug: STZ - 5FU First	SAEs	26		Patients

1 to 10 of 54Source ClinicalTrials.gov

See all 54 results by group

Participant flow12

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

Period	Milestone	Group	Participants
First Course Treatment	STARTED	Sequence A, Drug: Everolimus First	72
First Course Treatment	STARTED	Sequence B, Drug: STZ - 5FU First	69
First Course Treatment	COMPLETED	Sequence A, Drug: Everolimus First	36
First Course Treatment	COMPLETED	Sequence B, Drug: STZ - 5FU First	33
First Course Treatment	NOT COMPLETED	Sequence A, Drug: Everolimus First	36
First Course Treatment	NOT COMPLETED	Sequence B, Drug: STZ - 5FU First	36
Second Course Treatment	STARTED	Sequence A, Drug: Everolimus First	36
Second Course Treatment	STARTED	Sequence B, Drug: STZ - 5FU First	33
Second Course Treatment	COMPLETED	Sequence A, Drug: Everolimus First	36
Second Course Treatment	COMPLETED	Sequence B, Drug: STZ - 5FU First	33

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events222

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	Fever	General disorders	Everolimus	14	105
other	Fever	General disorders	STZ - 5FU	5	104
other	Abdominal pain	Gastrointestinal disorders	Everolimus	14	105
other	Abdominal pain	Gastrointestinal disorders	STZ - 5FU	17	104
other	Hyperglycemia	Metabolism and nutrition disorders	Everolimus	23	105
other	Hyperglycemia	Metabolism and nutrition disorders	STZ - 5FU	9	104
other	Constipation	Gastrointestinal disorders	Everolimus	10	105
other	Constipation	Gastrointestinal disorders	STZ - 5FU	15	104
other	Hypertriglyceridemia	Metabolism and nutrition disorders	Everolimus	8	105
other	Hypertriglyceridemia	Metabolism and nutrition disorders	STZ - 5FU	0	104

1 to 10 of 222Source ClinicalTrials.gov

See all 222 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Everolimus	26	105
Total, all-cause mortality	STZ - 5FU	35	104
Total, other adverse events	Everolimus	68	105
Total, other adverse events	STZ - 5FU	62	104
Total, serious adverse events	Everolimus	28	105
Total, serious adverse events	STZ - 5FU	26	104

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 comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Everolimus vs STZ - 5FU: deaths from any cause	Trial comparisons
Everolimus vs STZ - 5FU: serious adverse events	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/NCT02246127

GET https://conductscience.org/api/trials/v1/NCT02246127/results?page=2

API reference For AI assistants