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

Sponsor
Novartis Pharmaceuticals (Industry)
Overall Status
Completed
CT.gov ID
NCT00958971
Collaborator
(none)
43
Enrollment
38
Locations
3
Arms
20
Duration (Months)
1.1
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
43 participants
Allocation:
Non-Randomized
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 :
Jul 1, 2009
Actual Primary Completion Date :
Mar 1, 2011
Actual Study Completion Date :
Mar 1, 2011

Arms and Interventions

Arm Intervention/Treatment
Experimental: TKI258 - Positive

These are the participants who had a positive T(4;14) status

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.
Other Names:
  • Dovitinib

    		•
    Experimental: TKI258 - Negative

    These are the participants who had a negative T(4;14) status

    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.
    Other Names:
  • Dovitinib

    		•
    Experimental: TKI258 Non-interpretable

    These are the participants who had a non-interpretable T(4;14) status

    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.
    Other Names:
  • Dovitinib

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Complete responses (CR) or partial response (PR) defined according to RECIST [Every 8 weeks]

    Secondary Outcome Measures

    1. Clinical Benefit (CR, PR and SD ≥ 24 weeks after start of study treatment), PFS [Every 8 weeks]

    2. Safety and tolerability of TKI258 treatment assessed by frequency and severity of Adverse Events. [Monthly]

    3. Pharmacokinetic: plasma concentrations and PK parameters (e.g. Cmax, Tmax, AUC0-t) [Study Day 1, 5 , 26, 52, 78]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    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.

    1. 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%.

    1. 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).

    2. 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

    Locations

    Site City State Country Postal Code
    1 Comprehensive Blood and Cancer Center Dept CBCC (3) Bakersfield California United States 93309
    2 Tower Cancer Research Beverly Hills California United States 90211
    3 UCLA/ University of California Los Angeles Div. of Hematology/Oncology Los Angeles California United States 90095
    4 Cancer Care Associates Medical Group Dept. of CCA Redondo Beach California United States 90277
    5 Central Coast Medical Oncology Corporation Santa Maria California United States 93454
    6 Florida Cancer Specialists Dept.of FloridaCancerSpec. (2) Fort Myers Florida United States 33901
    7 Kansas City Cancer Center KCCC (3) Overland Park Kansas United States 66210
    8 Associates in Oncology/Hematology, P.C. Rockville Maryland United States 20850
    9 Comprehensive Cancer Centers of Nevada Henderson Nevada United States 89052
    10 UNC/ Lineberger Comprehensive Cancer Center Dept. of Linberger Cancer Ctr Chapel Hill North Carolina United States 27599-7295
    11 Northwest Cancer Specialists Northwest Office (2) Portland Oregon United States 97210
    12 Texas Oncology, P.A. Dept. of Texas Oncology Bedford Texas United States 76022
    13 Texas Oncology, P.A. Austin Dallas Texas United States 75246
    14 Texas Oncology, P.A. Presbyterian Hospital Dallas Texas United States 75246
    15 Texas Oncology, P.A. Texas Oncology - Sammons Dallas Texas United States 75246
    16 Tyler Cancer Center Dept.ofTylerCancerCtr. (2) Tyler Texas United States 75702
    17 Fairfax Northern Virginia Hematology Oncology Fairfax NVH Fairfax Virginia United States 22031
    18 Blue Ridge Research Center at Roanoke Neurological Center Blue Ridge Cancer Care Roanoke Virginia United States 24014
    19 Novartis Investigative Site Edmonton Alberta Canada T6G 1Z2
    20 Novartis Investigative Site Montreal Quebec Canada H2W 1T8
    21 Novartis Investigative Site Helsinki Finland FIN-00029
    22 Novartis Investigative Site Lyon Cedex France 69373
    23 Novartis Investigative Site Saint-Herblain Cédex France 44805
    24 Novartis Investigative Site Toulouse Cedex 3 France 31052
    25 Novartis Investigative Site Villejuif Cedex France 94805
    26 Novartis Investigative Site Cuneo CN Italy 12100
    27 Novartis Investigative Site Cremona CR Italy 26100
    28 Novartis Investigative Site Parma PR Italy 43100
    29 Novartis Investigative Site Candiolo TO Italy 10060
    30 Novartis Investigative Site Napoli Italy 80131
    31 Novartis Investigative Site Negrar Italy 37024
    32 Novartis Investigative Site Barcelona Cataluña Spain 08035
    33 Novartis Investigative Site Lleida Cataluña Spain 25198
    34 Novartis Investigative Site Madrid Spain 28041
    35 Novartis Investigative Site Taipei Taiwan 10048
    36 Novartis Investigative Site Glasgow United Kingdom G12 0YN
    37 Novartis Investigative Site London United Kingdom SE1 9RT
    38 Novartis Investigative Site London United Kingdom SW3 6JJ

    Sponsors and Collaborators

    • Novartis Pharmaceuticals

    Investigators

    • Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Novartis Pharmaceuticals
    ClinicalTrials.gov Identifier:
    NCT00958971
    Other Study ID Numbers:
    • CTKI258A2202
    • 2008-006430-10
    First Posted:
    Aug 14, 2009
    Last Update Posted:
    Dec 19, 2020
    Last Verified:
    Sep 1, 2020
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Novartis Pharmaceuticals
    Breast cancer
    HER2 negative
    FGFR1
    Additional relevant MeSH terms:
    Breast Neoplasms

    Study Results

    No Results Posted as of Dec 19, 2020