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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00958971
Other study ID # CTKI258A2202
Secondary ID 2008-006430-10
Status Completed
Phase Phase 2
First received
Last updated
Start date July 2009
Est. completion date March 2011

Study information

Verified date September 2020
Source Novartis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this trial is to determine the efficacy and safety profile of TKI258 in 3 groups of patients with metastatic HER2 negative breast cancer (BC) stratified by FGFR1 and hormone receptor (HR) status.


Recruitment information / eligibility

Status Completed
Enrollment 43
Est. completion date March 2011
Est. primary completion date March 2011
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Female presenting with metastatic breast cancer. 2. Tumor must have been tested by FISH/CISH for FGFR1 amplification. 3. HER2 and HR status must have been determined. 4. Patients must have HER2 negative breast cancer. 5. Patients must have a documented disease progression as define by RECIST at baseline. 6. Patients with HR+ disease: - Must have received at least one prior endocrine therapy in the metastatic setting. - Must have received no more than three lines of chemotherapy in the metastatic setting. 7. Patients with HR- disease must have received at least one and no more than three lines of chemotherapy in metastatic setting. Exclusion Criteria: 1. Patients with known brain metastases or who have signs/symptoms attributable to brain metastases and have not been assessed with radiologic imaging to rule out the presence of brain metastases. 2. Impaired cardiac function or clinically significant cardiac diseases, including any of the following: - History or presence of serious uncontrolled ventricular arrhythmias or presence of atrial fibrillation. - Clinically significant resting bradycardia (< 50 beats per minute). - LVEF assessed by 2-D echocardiogram (ECHO) or Multiple gated acquisition scanning (MUGA)< 45%. 3. Any of the following within 6 months prior to study entry: myocardial infarction (MI), severe/unstable angina, Coronary Artery Bypass Graft (CABG), Congestive Heart Failure (CHF), Cerebrovascular Accident (CVA), Transient Ischemic Attack (TIA), Pulmonary Embolism (PE). 4. Uncontrolled hypertension defined by a SBP > 150mm Hg and/or DBP > 100mm Hg, with or without anti-hypertensive medication. Other protocol-defined inclusion/exclusion criteria may apply

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
TKI258
All participants received a singly daily oral dose of 500 mg dovitinib on a 5 days on/2 days off schedule in 28 cycles.

Locations

Country Name City State
Canada Novartis Investigative Site Edmonton Alberta
Canada Novartis Investigative Site Montreal Quebec
Finland Novartis Investigative Site Helsinki
France Novartis Investigative Site Lyon Cedex
France Novartis Investigative Site Saint-Herblain Cédex
France Novartis Investigative Site Toulouse Cedex 3
France Novartis Investigative Site Villejuif Cedex
Italy Novartis Investigative Site Candiolo TO
Italy Novartis Investigative Site Cremona CR
Italy Novartis Investigative Site Cuneo CN
Italy Novartis Investigative Site Napoli
Italy Novartis Investigative Site Negrar
Italy Novartis Investigative Site Parma PR
Spain Novartis Investigative Site Barcelona Cataluña
Spain Novartis Investigative Site Lleida Cataluña
Spain Novartis Investigative Site Madrid
Taiwan Novartis Investigative Site Taipei
United Kingdom Novartis Investigative Site Glasgow
United Kingdom Novartis Investigative Site London
United Kingdom Novartis Investigative Site London
United States Comprehensive Blood and Cancer Center Dept CBCC (3) Bakersfield California
United States Texas Oncology, P.A. Dept. of Texas Oncology Bedford Texas
United States Tower Cancer Research Beverly Hills California
United States UNC/ Lineberger Comprehensive Cancer Center Dept. of Linberger Cancer Ctr Chapel Hill North Carolina
United States Texas Oncology, P.A. Austin Dallas Texas
United States Texas Oncology, P.A. Presbyterian Hospital Dallas Texas
United States Texas Oncology, P.A. Texas Oncology - Sammons Dallas Texas
United States Fairfax Northern Virginia Hematology Oncology Fairfax NVH Fairfax Virginia
United States Florida Cancer Specialists Dept.of FloridaCancerSpec. (2) Fort Myers Florida
United States Comprehensive Cancer Centers of Nevada Henderson Nevada
United States UCLA/ University of California Los Angeles Div. of Hematology/Oncology Los Angeles California
United States Kansas City Cancer Center KCCC (3) Overland Park Kansas
United States Northwest Cancer Specialists Northwest Office (2) Portland Oregon
United States Cancer Care Associates Medical Group Dept. of CCA Redondo Beach California
United States Blue Ridge Research Center at Roanoke Neurological Center Blue Ridge Cancer Care Roanoke Virginia
United States Associates in Oncology/Hematology, P.C. Rockville Maryland
United States Central Coast Medical Oncology Corporation Santa Maria California
United States Tyler Cancer Center Dept.ofTylerCancerCtr. (2) Tyler Texas

Sponsors (1)

Lead Sponsor Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Canada,  Finland,  France,  Italy,  Spain,  Taiwan,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Complete responses (CR) or partial response (PR) defined according to RECIST Every 8 weeks
Secondary Clinical Benefit (CR, PR and SD = 24 weeks after start of study treatment), PFS Every 8 weeks
Secondary Safety and tolerability of TKI258 treatment assessed by frequency and severity of Adverse Events. Monthly
Secondary Pharmacokinetic: plasma concentrations and PK parameters (e.g. Cmax, Tmax, AUC0-t) Study Day 1, 5 , 26, 52, 78
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