Safety and Efficacy of TKI258 in FGFR1 Amplified and Non-amplified Metastatic HER2 Negative Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00958971
Recruitment Status : Completed
First Posted : August 14, 2009
Last Update Posted : February 12, 2013
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:
The purpose of this trial is to determine the efficacy and safety profile of TKI258 in 4 groups of patients with metastatic HER2 negative breast cancer (BC) stratified by FGFR1 and hormone receptor (HR) status.

Condition or disease Intervention/treatment Phase
Metastatic Breast Cancer Drug: TKI258 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 165 participants
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multi-center, Open Label Phase II Trial of TKI258 in FGFR1 Amplified and Non-amplified Metastatic or Advanced HER2 Negative Breast Cancer
Study Start Date : July 2009
Actual Primary Completion Date : March 2011
Actual Study Completion Date : March 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: TKI258 Drug: TKI258

Primary Outcome Measures :
  1. Complete responses (CR) or partial response (PR) defined according to RECIST [ Time Frame: Every 8 weeks ]

Secondary Outcome Measures :
  1. Clinical Benefit (CR, PR and SD ≥ 24 weeks after start of study treatment), PFS [ Time Frame: Every 8 weeks ]
  2. Safety and tolerability of TKI258 treatment assessed by frequency and severity of Adverse Events. [ Time Frame: Monthly ]
  3. Pharmacokinetic: plasma concentrations and PK parameters (e.g. Cmax, Tmax, AUC0-t) [ Time Frame: Study Day 1, 5 , 26, 52, 78 ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00958971

  Hide Study Locations
United States, California
Comprehensive Blood and Cancer Center Dept CBCC (3)
Bakersfield, California, United States, 93309
Tower Cancer Research
Beverly Hills, California, United States, 90211
UCLA/ University of California Los Angeles Div. of Hematology/Oncology
Los Angeles, California, United States, 90095
Cancer Care Associates Medical Group Dept. of CCA
Redondo Beach, California, United States, 90277
Central Coast Medical Oncology Corporation
Santa Maria, California, United States, 93454
United States, Florida
Florida Cancer Specialists Dept.of FloridaCancerSpec. (2)
Fort Myers, Florida, United States, 33901
United States, Kansas
Kansas City Cancer Center KCCC (3)
Overland Park, Kansas, United States, 66210
United States, Maryland
Associates in Oncology/Hematology, P.C.
Rockville, Maryland, United States, 20850
United States, Nevada
Comprehensive Cancer Centers of Nevada
Henderson, Nevada, United States, 89052
United States, North Carolina
UNC/ Lineberger Comprehensive Cancer Center Dept. of Linberger Cancer Ctr
Chapel Hill, North Carolina, United States, 27599-7295
United States, Oregon
Northwest Cancer Specialists Northwest Office (2)
Portland, Oregon, United States, 97210
United States, Texas
Texas Oncology, P.A. Dept. of Texas Oncology
Bedford, Texas, United States, 76022
Texas Oncology, P.A. Austin
Dallas, Texas, United States, 75246
Texas Oncology, P.A. Presbyterian Hospital
Dallas, Texas, United States, 75246
Texas Oncology, P.A. Texas Oncology - Sammons
Dallas, Texas, United States, 75246
Tyler Cancer Center Dept.ofTylerCancerCtr. (2)
Tyler, Texas, United States, 75702
United States, Virginia
Fairfax Northern Virginia Hematology Oncology Fairfax NVH
Fairfax, Virginia, United States, 22031
Blue Ridge Research Center at Roanoke Neurological Center Blue Ridge Cancer Care
Roanoke, Virginia, United States, 24014
Canada, Alberta
Novartis Investigative Site
Edmonton, Alberta, Canada, T6G 1Z2
Canada, Quebec
Novartis Investigative Site
Montreal, Quebec, Canada, H2W 1T8
Novartis Investigative Site
Helsinki, Finland, FIN-00029
Novartis Investigative Site
Lyon Cedex, France, 69373
Novartis Investigative Site
Saint-Herblain Cédex, France, 44805
Novartis Investigative Site
Toulouse Cedex 3, France, 31052
Novartis Investigative Site
Villejuif Cedex, France, 94805
Novartis Investigative Site
Cuneo, CN, Italy, 12100
Novartis Investigative Site
Cremona, CR, Italy, 26100
Novartis Investigative Site
Parma, PR, Italy, 43100
Novartis Investigative Site
Candiolo, TO, Italy, 10060
Novartis Investigative Site
Napoli, Italy, 80131
Novartis Investigative Site
Negrar, Italy, 37024
Novartis Investigative Site
Barcelona, Cataluña, Spain, 08035
Novartis Investigative Site
Lleida, Cataluña, Spain, 25198
Novartis Investigative Site
Madrid, Spain, 28041
Novartis Investigative Site
Taipei, Taiwan, 10048
United Kingdom
Novartis Investigative Site
Glasgow, United Kingdom, G12 0YN
Novartis Investigative Site
London, United Kingdom, SE1 9RT
Novartis Investigative Site
London, United Kingdom, SW3 6JJ
Sponsors and Collaborators
Novartis Pharmaceuticals
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

Responsible Party: Novartis Pharmaceuticals Identifier: NCT00958971     History of Changes
Other Study ID Numbers: CTKI258A2202
2008-006430-10 ( EudraCT Number )
First Posted: August 14, 2009    Key Record Dates
Last Update Posted: February 12, 2013
Last Verified: February 2013

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Breast cancer
HER2 negative

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases