Clinical 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
Official title: An Open Label, Multi-center, Extension Study to Evaluate Long-term Safety and Tolerability of Dovitinib in Patients With Solid Tumors, Who Continue to Receive Treatment With Dovitinib (TKI258) in Novartis-sponsored, Single Agent Dovitinib Studies, Which Have Fulfilled the Requirements for the Primary Objective, and Are Benefitting From Continued Dovitinib Treatment as Assessed by the Investigator
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Solid Tumors
Keywords: solid tumors
TKI258
Dovitinib
fulvestrant
cancers with a mass
bulky tumor
nodule
lump
cancer
solid malignancies
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2014-04-17
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* patient was currently enrolled in Novartis sponsored study, which had met its endpoint and was receiving single agent oral dovitinib or dovitinib and fulvestrant coadministration
* patient was currently benefiting from treatment with single agent oral dovitinib or dovitinib and fulvestrant coadministration as determined by the guidelines of the parent protocol and according to the investigator's clinical judgment.
* patient had demonstated compliance
* patient had given written informed consent.

Exclusion Criteria:

* patient had been permanently discontinued from oral dovitinib study treatment, either alone or in combination with fulvestrant, in the parent study
* patient was pregnant or nursing at the time of entry
* women of child-bearing potential and male patients with sexual partners of child-bearing potential unwilling to use highly effective methods of contraception during dosing and for a specified duration after stopping study treatment

Primary outcomes:
measure: Number of Participants With Adverse Events of Grades 3 and 4 Severity
timeFrame: Until the last patient discontinued dovitinib up to 30 months
Secondary outcomes:
Other outcomes:
Locations:
city: Las Vegas
country: United States
facility: Novartis Investigative Site
state: Nevada
city: Bronx
country: United States
facility: Novartis Investigative Site
state: New York
city: Salzburg
country: Austria
facility: Novartis Investigative Site
city: Wilrijk
country: Belgium
facility: Novartis Investigative Site
city: Copenhagen
country: Denmark
facility: Novartis Investigative Site
city: Pavia
country: Italy
facility: Novartis Investigative Site
state: PV
city: Torino
country: Italy
facility: Novartis Investigative Site
state: TO
city: Osaka-city
country: Japan
facility: Novartis Investigative Site
state: Osaka
city: Palma De Mallorca
country: Spain
facility: Novartis Investigative Site
state: Islas Baleares
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: