Trial · NCT02116803

An Open Label Multi-center Extension Study to Evaluate Long-term Safety/ Tolerability of Dovitinib in Patients With Solid Tumors Who Continue to Receive Treatment With Dovitinib (TKI258) in Novartis-sponsored Single Agent Dovitinib Studies Which Fulfilled the Requirements for the Primary Objective

NCT02116803, Phase 2, Phase 3, Completed, Novartis Pharmaceuticals; results first posted 2018-02-01

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. An Open Label Multi-center Extension Study to Evaluate Long-term Safety/ Tolerability of Dovitinib in Patients With Solid Tumors Who Continue to Receive Treatment With Dovitinib (TKI258) in Novartis-sponsored Single Agent Dovitinib Studies Which Fulfilled the Requirements for the Primary Objective. Trials, record NCT02116803. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02116803

On this page

Trial

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

Title: An Open Label Multi-center Extension Study to Evaluate Long-term Safety/ Tolerability of Dovitinib in Patients With Solid Tumors Who Continue to Receive Treatment With Dovitinib (TKI258) in Novartis-sponsored Single Agent Dovitinib Studies Which Fulfilled the Requirements for the Primary Objective
NCT number: NCT02116803
Status: Completed
Phases: Phase 2, Phase 3
Enrollment: 12 participants, actual
Lead sponsor: Novartis Pharmaceuticals
Conditions: Solid Tumors
Interventions: dovitinib, fulvestrant
First posted: 2014-04-17
Last updated: 2018-03-01
Other registries' IDs: eudract:2014-000368-17
Results first posted: 2018-02-01

Source ClinicalTrials.gov

Registered outcomes1

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

List	Outcome	Time frame	Description
Primary	Number of Participants With Adverse Events of Grades 3 and 4 Severity	Until the last patient discontinued dovitinib up to 30 months	Participants with grades 3 and 4 severity adverse events were assessed according to the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03, unless otherwise specified. AEs are provided by System Organ Class (SOC). A patient with multiple adverse events within a primary system organ class was counted only once in the total row.

Source ClinicalTrials.gov

Outcomes1

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 Adverse Events of Grades 3 and 4 Severity	Until the last patient discontinued dovitinib up to 30 months	Safety set: the Safety set included all patients who received at least one dose of study medication. Safety set was identical to Full Analysis Set for this study.	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group38

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

Outcome	Group	Category	Value	Units
Number of Participants With Adverse Events of Grades 3 and 4 Severity	Dovitinib	Any Primary system organ class	6	Participants
Number of Participants With Adverse Events of Grades 3 and 4 Severity	Dovitinib + Fulvestrant	Any Primary system organ class	2	Participants
Number of Participants With Adverse Events of Grades 3 and 4 Severity	Dovitinib	Blood and lymphatic system disorders	1	Participants
Number of Participants With Adverse Events of Grades 3 and 4 Severity	Dovitinib + Fulvestrant	Blood and lymphatic system disorders	0	Participants
Number of Participants With Adverse Events of Grades 3 and 4 Severity	Dovitinib	Cardiac disorders	2	Participants
Number of Participants With Adverse Events of Grades 3 and 4 Severity	Dovitinib + Fulvestrant	Cardiac disorders	1	Participants
Number of Participants With Adverse Events of Grades 3 and 4 Severity	Dovitinib	Ear and Labyrinth disorders	0	Participants
Number of Participants With Adverse Events of Grades 3 and 4 Severity	Dovitinib + Fulvestrant	Ear and Labyrinth disorders	0	Participants
Number of Participants With Adverse Events of Grades 3 and 4 Severity	Dovitinib	Endocrine disorders	0	Participants
Number of Participants With Adverse Events of Grades 3 and 4 Severity	Dovitinib + Fulvestrant	Endocrine disorders	0	Participants

1 to 10 of 38Source ClinicalTrials.gov

See all 38 results by group

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Dovitinib	10
Overall Study	STARTED	Dovitinib + Fulvestrant	2
Overall Study	COMPLETED	Dovitinib	0
Overall Study	COMPLETED	Dovitinib + Fulvestrant	0
Overall Study	NOT COMPLETED	Dovitinib	10
Overall Study	NOT COMPLETED	Dovitinib + Fulvestrant	2

Source ClinicalTrials.gov

Adverse events126

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	Dovitinib	2	10
other	ANAEMIA	Blood and lymphatic system disorders	Dovitinib+Fulvestrant	0	2
other	INCREASED TENDENCY TO BRUISE	Blood and lymphatic system disorders	Dovitinib	1	10
other	INCREASED TENDENCY TO BRUISE	Blood and lymphatic system disorders	Dovitinib+Fulvestrant	0	2
other	LEUKOPENIA	Blood and lymphatic system disorders	Dovitinib	1	10
other	LEUKOPENIA	Blood and lymphatic system disorders	Dovitinib+Fulvestrant	0	2
other	NEUTROPENIA	Blood and lymphatic system disorders	Dovitinib	1	10
other	NEUTROPENIA	Blood and lymphatic system disorders	Dovitinib+Fulvestrant	0	2
other	ANGINA PECTORIS	Cardiac disorders	Dovitinib	2	10
other	ANGINA PECTORIS	Cardiac disorders	Dovitinib+Fulvestrant	1	2

1 to 10 of 126Source ClinicalTrials.gov

See all 126 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Dovitinib
Total, all-cause mortality	Dovitinib+Fulvestrant
Total, other adverse events	Dovitinib	9	10
Total, other adverse events	Dovitinib+Fulvestrant	2	2
Total, serious adverse events	Dovitinib	4	10
Total, serious adverse events	Dovitinib+Fulvestrant	2	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 comparisons1

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

Comparison
Dovitinib vs Dovitinib+Fulvestrant: 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/NCT02116803

GET https://conductscience.org/api/trials/v1/NCT02116803/results?page=2

API reference For AI assistants