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
CompletedPhase 2, PHASE3Results postedLast updated 1 March 2018
What this trial tests
Phase 2, PHASE3 trial testing dovitinib in Solid Tumors in 12 participants. Completed in 28 November 2016.
18 and older, any sex, with Solid Tumors. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of Participants With Adverse Events of Grades 3 and 4 SeverityPrimary· 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.
Any Primary system organ class
Group
Value
95% CI
Dovitinib
6
Dovitinib + Fulvestrant
2
Blood and lymphatic system disorders
Group
Value
95% CI
Dovitinib
1
Dovitinib + Fulvestrant
0
Cardiac disorders
Group
Value
95% CI
Dovitinib
2
Dovitinib + Fulvestrant
1
Ear and Labyrinth disorders
Group
Value
95% CI
Dovitinib
0
Dovitinib + Fulvestrant
0
Endocrine disorders
Group
Value
95% CI
Dovitinib
0
Dovitinib + Fulvestrant
0
Eye disorders
Group
Value
95% CI
Dovitinib
0
Dovitinib + Fulvestrant
0
Gastrointestinal disorders
Group
Value
95% CI
Dovitinib
1
Dovitinib + Fulvestrant
0
General disorders & administration site conditions
Group
Value
95% CI
Dovitinib
1
Dovitinib + Fulvestrant
0
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 2.5 years..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Dovitinib
Serious: 4/10 (40%)
Deaths: —
Dovitinib+Fulvestrant
Serious: 2/2 (100%)
Deaths: —
Serious adverse events (8 terms)
Reaction
System
Dovitinib
Dovitinib+Fulvestrant
ACUTE MYOCARDIAL INFARCTION
Cardiac disorders
—
—
BRADYCARDIA
Cardiac disorders
—
—
CORONARY ARTERY DISEASE
Cardiac disorders
—
—
MYOCARDIAL ISCHAEMIA
Cardiac disorders
—
—
PNEUMONIA
Infections and infestations
—
—
ADENOCARCINOMA OF COLON
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
The study allowed continued safety follow-up of patients who were on single agent dovitinib or dovitinib in combination with fulvestrant treatment in a Novartis-sponsored study which had met its primary endpoint and were benefiting from the treatment as judged by the investigator.
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
NCT01753713 — Dovitinib in Treating Patients With Recurrent or Progressive Glioblastoma
· Phase 2
· completed
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Trials by the same sponsor.
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Novartis Pharmaceuticals
Last refreshed: 1 March 2018
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02116803.