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

Solid Tumors Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02116803
• Other study ID #: CTKI258A2X01B
• Secondary ID: 2014-000368-17
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: April 15, 2014
• Last updated: January 31, 2018
• Start date: May 28, 2014
• Est. completion date: November 28, 2016

Study information

• Verified date: January 2018
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: November 28, 2016
• Est. primary completion date: November 28, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Solid Tumors

Intervention

Drug:
• dovitinib
Dovitinib was available in two formulations: capsules of 100 mg strength, and tablets of 100 mg strength and taken orally.
• fulvestrant
Fulvestrant is generally available as solution for injection in pre-filled syringes containing 250 mg of fulvestrant in 5 mL solution.

Locations

Country	Name	City	State
Austria	Novartis Investigative Site	Salzburg
Belgium	Novartis Investigative Site	Wilrijk
Denmark	Novartis Investigative Site	Copenhagen
Italy	Novartis Investigative Site	Pavia	PV
Italy	Novartis Investigative Site	Torino	TO
Japan	Novartis Investigative Site	Osaka-city	Osaka
Spain	Novartis Investigative Site	Palma De Mallorca	Islas Baleares
United States	Novartis Investigative Site	Bronx	New York
United States	Novartis Investigative Site	Las Vegas	Nevada

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Austria,  Belgium,  Denmark,  Italy,  Japan,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Adverse Events of Grades 3 and 4 Severity	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.	Until the last patient discontinued dovitinib up to 30 months