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

This study has been completed.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals ) Identifier:
First received: August 11, 2009
Last updated: February 9, 2013
Last verified: February 2013
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 Intervention Phase
Metastatic Breast Cancer Drug: TKI258 Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Novartis ( Novartis Pharmaceuticals ):

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

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

Enrollment: 165
Study Start Date: July 2009
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TKI258 Drug: TKI258


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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

  Contacts and Locations
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Please refer to this study by its identifier: NCT00958971

  Show 38 Study Locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Responsible Party: Novartis Pharmaceuticals Identifier: NCT00958971     History of Changes
Other Study ID Numbers: CTKI258A2202
2008-006430-10 ( EudraCT Number )
Study First Received: August 11, 2009
Last Updated: February 9, 2013

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

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases processed this record on September 19, 2017