Trial · NCT02315625

Study of Mutation-Targeted Therapy With Sunitinib or Everolimus in People With Advanced Low- or Intermediate-Grade Neuroendocrine Tumors of the Gastrointestinal Tract and Pancreas With or Without Cytoreductive Surgery

NCT02315625, Phase 2, Terminated, National Cancer Institute (NCI); results first posted 2020-09-09

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Study of Mutation-Targeted Therapy With Sunitinib or Everolimus in People With Advanced Low- or Intermediate-Grade Neuroendocrine Tumors of the Gastrointestinal Tract and Pancreas With or Without Cytoreductive Surgery. Trials, record NCT02315625. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02315625

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Trial

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

Title: Study of Mutation-Targeted Therapy With Sunitinib or Everolimus in People With Advanced Low- or Intermediate-Grade Neuroendocrine Tumors of the Gastrointestinal Tract and Pancreas With or Without Cytoreductive Surgery
NCT number: NCT02315625
Status: Terminated
Phases: Phase 2
Enrollment: 16 participants, actual
Lead sponsor: National Cancer Institute (NCI)
Conditions: Neuroendocrine Tumors, Neuroendocrine Carcinoma, Neuroendocrine Neoplasms, Carcinoma, Neuroendocrine, Neuroendocrine Tumors of the Gastrointestinal Tract and Pancreas
Interventions: Sunitinib, Everolimus
First posted: 2014-12-12
Last updated: 2020-09-09
Results first posted: 2020-09-09

Source ClinicalTrials.gov

Registered outcomes5

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

List	Outcome	Time frame	Description
Primary	Median Amount of Time Subject Survives Without Disease Progression After Treatment	Up to approximately 2 years	Median amount of time subject survives without disease progression after treatment. Progression was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) and is at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progressions.
Secondary	Number of Participants With an Overall Response	Every 3 months until disease progression, up to 12 months	Overall response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) is defined as Complete Response (CR), Partial Response (PR), and Stable Disease (SD). Complete Response is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial Response is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters. Stable Disease is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for Progressive Disease (PD) (e.g. appearance of one or more new lesions), taking as reference the smallest sum of diameters while on study.
Secondary	Overall Survival	Up to approximately 4 years	Overall survival is defined as the time from treatment start date until date of death or date last known alive following therapy.
Secondary	Median Survival Time (MST)	Death, an average of 12 months follow up	MST is the amount of time a subject survives after therapy.
Secondary	Number of Participants With Serious and Non-Serious Adverse Events	Date treatment consent signed to date off study approximately 49 months and 9 days.	Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.

Source ClinicalTrials.gov

Outcomes5

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Median Amount of Time Subject Survives Without Disease Progression After Treatment	Up to approximately 2 years	The data in this outcome measure is reported per sequence as pre-specified in the protocol.	months	MEDIAN
SECONDARY	Number of Participants With an Overall Response	Every 3 months until disease progression, up to 12 months	The data in this outcome measure is reported per sequence as pre-specified in the protocol.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Overall Survival	Up to approximately 4 years	The data in this outcome measure is reported per sequence as pre-specified in the protocol.	Months	MEDIAN
SECONDARY	Median Survival Time (MST)	Death, an average of 12 months follow up	The data in this outcome measure is reported per sequence as pre-specified in the protocol.	Months	MEDIAN
SECONDARY	Number of Participants With Serious and Non-Serious Adverse Events	Date treatment consent signed to date off study approximately 49 months and 9 days.	One participant did not receive Sunitinib and 5 did not receive Everolimus.	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group10

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

Outcome	Group	Value	Spread	Units
Median Amount of Time Subject Survives Without Disease Progression After Treatment	Sunitinib First, Everolimus Second	7	Full Range 3 to 15	months
Median Amount of Time Subject Survives Without Disease Progression After Treatment	Everolimus First, Sunitinib Second	18	Full Range 0 to 18	months
Number of Participants With an Overall Response	Sunitinib First, Everolimus Second	1		Participants
Number of Participants With an Overall Response	Everolimus First, Sunitinib Second	0		Participants
Overall Survival	Sunitinib First, Everolimus Second	25.5	Full Range 6 to 39	Months
Overall Survival	Everolimus First, Sunitinib Second	10.7	Full Range 0.427397 to 21	Months
Median Survival Time (MST)	Sunitinib First, Everolimus Second	9.5	Full Range 0.4927 to 33	Months
Median Survival Time (MST)	Everolimus First, Sunitinib Second	5.5	Full Range 0 to 11	Months
Number of Participants With Serious and Non-Serious Adverse Events	Sunitinib	15		Participants
Number of Participants With Serious and Non-Serious Adverse Events	Everolimus	11		Participants

Source ClinicalTrials.gov

Participant flow12

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

Period	Milestone	Group	Participants
First Intervention	STARTED	Sunitinib Followed by Everolimus	14
First Intervention	STARTED	Everolimus Followed by Sunitinib	2
First Intervention	COMPLETED	Sunitinib Followed by Everolimus	13
First Intervention	COMPLETED	Everolimus Followed by Sunitinib	2
First Intervention	NOT COMPLETED	Sunitinib Followed by Everolimus	1
First Intervention	NOT COMPLETED	Everolimus Followed by Sunitinib	0
Second Intervention	STARTED	Sunitinib Followed by Everolimus	13
Second Intervention	STARTED	Everolimus Followed by Sunitinib	2
Second Intervention	COMPLETED	Sunitinib Followed by Everolimus	9
Second Intervention	COMPLETED	Everolimus Followed by Sunitinib	1

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events108

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	Abdominal pain	Gastrointestinal disorders	Sunitinib	1	15	1
other	Abdominal pain	Gastrointestinal disorders	Everolimus	1	11	6
other	Agitation	Psychiatric disorders	Sunitinib	1	15	1
other	Agitation	Psychiatric disorders	Everolimus	0	11	0
other	Alanine aminotransferase increased	Investigations	Sunitinib	1	15	1
other	Alanine aminotransferase increased	Investigations	Everolimus	0	11	0
other	Anemia	Blood and lymphatic system disorders	Sunitinib	3	15	5
other	Anemia	Blood and lymphatic system disorders	Everolimus	3	11	5
other	Anorexia	Metabolism and nutrition disorders	Sunitinib	0	15	0
other	Anorexia	Metabolism and nutrition disorders	Everolimus	1	11	1

1 to 10 of 108Source ClinicalTrials.gov

See all 108 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Sunitinib	1	15
Total, all-cause mortality	Everolimus	1	11
Total, other adverse events	Sunitinib	14	15
Total, other adverse events	Everolimus	7	11
Total, serious adverse events	Sunitinib	3	15
Total, serious adverse events	Everolimus	2	11

Source ClinicalTrials.gov

Papers6

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
18332467	BACKGROUND	PubMed
19453268	BACKGROUND	PubMed
23846929	BACKGROUND	PubMed
25991462	RESULT	PubMed
26678657	DERIVED	PubMed
30865533	RESULT	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 comparisons4

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

Comparison	Source
Sunitinib First, Everolimus Second vs Everolimus First, Sunitinib Second: Number of Participants With an Overall Response	Trial comparisons
Sunitinib vs Everolimus: Number of Participants With Serious and Non-Serious Adverse Events	Trial comparisons
Sunitinib vs Everolimus: deaths from any cause	Trial comparisons
Sunitinib vs Everolimus: 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/NCT02315625

GET https://conductscience.org/api/trials/v1/NCT02315625/events?page=2

API reference For AI assistants