Trial · NCT02015065

Phase II Trial of Vandetanib in Children and Adults With Wild-Type Gastrointestinal Stromal Tumors

NCT02015065, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2019-07-23

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Phase II Trial of Vandetanib in Children and Adults With Wild-Type Gastrointestinal Stromal Tumors. Trials, record NCT02015065. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02015065

On this page

Trial

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

Title: Phase II Trial of Vandetanib in Children and Adults With Wild-Type Gastrointestinal Stromal Tumors
NCT number: NCT02015065
Status: Completed
Phases: Phase 2
Enrollment: 9 participants, actual
Lead sponsor: National Cancer Institute (NCI)
Conditions: GIST
Interventions: Vandetanib
First posted: 2013-12-19
Last updated: 2020-03-30
Results first posted: 2019-07-23

Source ClinicalTrials.gov

Registered outcomes5

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

List	Outcome	Time frame	Description
Primary	Number of Participants With a Clinical Activity-radiographic Response	Every 3 cycles x4 and then every 6 cycles (1 cycle = 28 days) until removal from protocol therapy, an average of 12 months.	Clinical activity will be assessed primarily by radiographic response of measurable disease using the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Complete Response is disappearance of all target lesions. Any pathological lymph nodes 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 diameters. Progressive Disease 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); (Note: the appearance of one or more new lesions is also considered progressions). Stable Disease is neither sufficient shrinkage to qualify for Partial Response nor sufficient increase to qualify for Progressive Disease, taking as reference the smallest sum diameters while on study.
Secondary	Count of Participants With Serious and Non-serious Adverse Events	Date treatment consent signed to date off study, approximately 32 months and 1 day.	The count of participants with serious and non-serious adverse events was 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.
Secondary	Percentage of Participants Overall Survival	Overall survival was computed using the number of months from the date of on study to the date of death, an average of 12 months.	Overall survival is defined as the date of on-study to the date of death from any cause or last follow up.
Secondary	Progression Free-Survival	Patients will be evaluated approximately 60 days after last dose of investigational drug until removal of protocol therapy, an average of 12 months.	Progression free survival is defined as the time interval from start of treatment to documented evidence of disease progression. Disease progression was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 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. (Note: the appearance of one or more new lesions is also considered progressions).
Secondary	Maximum Standardized Uptake Value (SUVmax) on Fluorodeoxyglucose Positron Emission Tomography (FDG-PET)	Baseline and at a subsequent PET performed on or about day 3-6 of cycle 1	The maximum standardized uptake value (SUVmax) was used to measure the uptake of FDG-PET by the Gastrointestinal Tumors.

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	Number of Participants With a Clinical Activity-radiographic Response	Every 3 cycles x4 and then every 6 cycles (1 cycle = 28 days) until removal from protocol therapy, an average of 12 months.		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Count of Participants With Serious and Non-serious Adverse Events	Date treatment consent signed to date off study, approximately 32 months and 1 day.		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Percentage of Participants Overall Survival	Overall survival was computed using the number of months from the date of on study to the date of death, an average of 12 months.		percentage of participants	NUMBER
SECONDARY	Progression Free-Survival	Patients will be evaluated approximately 60 days after last dose of investigational drug until removal of protocol therapy, an average of 12 months.		Months	MEDIAN
SECONDARY	Maximum Standardized Uptake Value (SUVmax) on Fluorodeoxyglucose Positron Emission Tomography (FDG-PET)	Baseline and at a subsequent PET performed on or about day 3-6 of cycle 1	Data were only collected from patients \>/= 15 years of age.	g/mL	MEDIAN

Source ClinicalTrials.gov

Results by group25

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

Outcome	Group	Category	Value	Units
Number of Participants With a Clinical Activity-radiographic Response	200 mg Vandetanib Adult	Complete Response	0	Participants
Number of Participants With a Clinical Activity-radiographic Response	300 mg Vandetanib Adult	Complete Response	0	Participants
Number of Participants With a Clinical Activity-radiographic Response	Dose Level 100mg/m^2 Vandetanib Pediatric	Complete Response	0	Participants
Number of Participants With a Clinical Activity-radiographic Response	200 mg Vandetanib Adult	Partial Response	0	Participants
Number of Participants With a Clinical Activity-radiographic Response	300 mg Vandetanib Adult	Partial Response	0	Participants
Number of Participants With a Clinical Activity-radiographic Response	Dose Level 100mg/m^2 Vandetanib Pediatric	Partial Response	0	Participants
Number of Participants With a Clinical Activity-radiographic Response	200 mg Vandetanib Adult	Stable Disease	1	Participants
Number of Participants With a Clinical Activity-radiographic Response	300 mg Vandetanib Adult	Stable Disease	2	Participants
Number of Participants With a Clinical Activity-radiographic Response	Dose Level 100mg/m^2 Vandetanib Pediatric	Stable Disease	1	Participants
Number of Participants With a Clinical Activity-radiographic Response	200 mg Vandetanib Adult	Progressive Disease	1	Participants

1 to 10 of 25Source ClinicalTrials.gov

See all 25 results by group

Participant flow9

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

Period	Milestone	Group	Participants
Overall Study	STARTED	200 mg Vandetanib Adult	2
Overall Study	STARTED	300 mg Vandetanib Adult	5
Overall Study	STARTED	Dose Level 100mg/m^2 Vandetanib Pediatric	2
Overall Study	COMPLETED	200 mg Vandetanib Adult	1
Overall Study	COMPLETED	300 mg Vandetanib Adult	3
Overall Study	COMPLETED	Dose Level 100mg/m^2 Vandetanib Pediatric	1
Overall Study	NOT COMPLETED	200 mg Vandetanib Adult	1
Overall Study	NOT COMPLETED	300 mg Vandetanib Adult	2
Overall Study	NOT COMPLETED	Dose Level 100mg/m^2 Vandetanib Pediatric	1

Source ClinicalTrials.gov

Adverse events219

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	Alopecia	Skin and subcutaneous tissue disorders	200 mg Vandetanib Adult	2	2	2
other	Alopecia	Skin and subcutaneous tissue disorders	300 mg Vandetanib Adult	0	5	0
other	Alopecia	Skin and subcutaneous tissue disorders	Dose Level 100mg/m^2 Vandetanib Pediatric	0	2	0
other	Aspartate aminotransferase increased	Investigations	200 mg Vandetanib Adult	1	2	1
other	Aspartate aminotransferase increased	Investigations	300 mg Vandetanib Adult	4	5	6
other	Aspartate aminotransferase increased	Investigations	Dose Level 100mg/m^2 Vandetanib Pediatric	0	2	0
other	Creatinine increased	Investigations	200 mg Vandetanib Adult	1	2	1
other	Creatinine increased	Investigations	300 mg Vandetanib Adult	1	5	3
other	Creatinine increased	Investigations	Dose Level 100mg/m^2 Vandetanib Pediatric	0	2	0
other	Dry skin	Skin and subcutaneous tissue disorders	200 mg Vandetanib Adult	1	2	1

1 to 10 of 219Source ClinicalTrials.gov

See all 219 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	200 mg Vandetanib Adult	1	2
Total, all-cause mortality	300 mg Vandetanib Adult	2	5
Total, all-cause mortality	Dose Level 100mg/m^2 Vandetanib Pediatric	1	2
Total, other adverse events	200 mg Vandetanib Adult	2	2
Total, other adverse events	300 mg Vandetanib Adult	5	5
Total, other adverse events	Dose Level 100mg/m^2 Vandetanib Pediatric	2	2
Total, serious adverse events	200 mg Vandetanib Adult	0	2
Total, serious adverse events	300 mg Vandetanib Adult	4	5
Total, serious adverse events	Dose Level 100mg/m^2 Vandetanib Pediatric	0	2

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 comparisons0

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

None in this release.

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/NCT02015065

GET https://conductscience.org/api/trials/v1/NCT02015065/results?page=2

API reference For AI assistants