MedTrace Logo

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 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2018-03-01

Study results available
· View outcomes & findings →

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.

Conditions

Interventions

DRUG

dovitinib

Dovitinib was available in two formulations: capsules of 100 mg strength, and tablets of 100 mg strength and taken orally.

DRUG

fulvestrant

Fulvestrant is generally available as solution for injection in pre-filled syringes containing 250 mg of fulvestrant in 5 mL solution.

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-05-28
Primary Completion
2016-11-28
Completion
2016-11-28
FDA Drug
Yes

Countries

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

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02116803 on ClinicalTrials.gov