Safety and Efficacy of TKI258 in FGFR1 Amplified and Non-amplified Metastatic HER2 Negative Breast Cancer
NCT ID: NCT00958971
Last Updated: 2020-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
43 participants
INTERVENTIONAL
2009-07-31
2011-03-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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TKI258 - Positive
These are the participants who had a positive T(4;14) status
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.
TKI258 - Negative
These are the participants who had a negative T(4;14) status
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.
TKI258 Non-interpretable
These are the participants who had a non-interpretable T(4;14) status
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.
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
FEMALE
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Comprehensive Blood and Cancer Center Dept CBCC (3)
Bakersfield, California, United States
Tower Cancer Research
Beverly Hills, California, United States
UCLA/ University of California Los Angeles Div. of Hematology/Oncology
Los Angeles, California, United States
Cancer Care Associates Medical Group Dept. of CCA
Redondo Beach, California, United States
Central Coast Medical Oncology Corporation
Santa Maria, California, United States
Florida Cancer Specialists Dept.of FloridaCancerSpec. (2)
Fort Myers, Florida, United States
Kansas City Cancer Center KCCC (3)
Overland Park, Kansas, United States
Associates in Oncology/Hematology, P.C.
Rockville, Maryland, United States
Comprehensive Cancer Centers of Nevada
Henderson, Nevada, United States
UNC/ Lineberger Comprehensive Cancer Center Dept. of Linberger Cancer Ctr
Chapel Hill, North Carolina, United States
Northwest Cancer Specialists Northwest Office (2)
Portland, Oregon, United States
Texas Oncology, P.A. Dept. of Texas Oncology
Bedford, Texas, 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
Tyler Cancer Center Dept.ofTylerCancerCtr. (2)
Tyler, Texas, United States
Fairfax Northern Virginia Hematology Oncology Fairfax NVH
Fairfax, Virginia, United States
Blue Ridge Research Center at Roanoke Neurological Center Blue Ridge Cancer Care
Roanoke, Virginia, United States
Novartis Investigative Site
Edmonton, Alberta, Canada
Novartis Investigative Site
Montreal, Quebec, Canada
Novartis Investigative Site
Helsinki, , Finland
Novartis Investigative Site
Lyon, , France
Novartis Investigative Site
Saint-Herblain Cédex, , France
Novartis Investigative Site
Toulouse, , France
Novartis Investigative Site
Villejuif, , France
Novartis Investigative Site
Cuneo, CN, Italy
Novartis Investigative Site
Cremona, CR, Italy
Novartis Investigative Site
Parma, PR, Italy
Novartis Investigative Site
Candiolo, TO, Italy
Novartis Investigative Site
Napoli, , Italy
Novartis Investigative Site
Negrar, , Italy
Novartis Investigative Site
Barcelona, Catalonia, Spain
Novartis Investigative Site
Lleida, Catalonia, Spain
Novartis Investigative Site
Madrid, , Spain
Novartis Investigative Site
Taipei, , Taiwan
Novartis Investigative Site
Glasgow, , United Kingdom
Novartis Investigative Site
London, , United Kingdom
Novartis Investigative Site
London, , United Kingdom
Countries
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Related Links
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Results for CTKI258A2202 from the Novartis Clinical Trials website
Other Identifiers
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2008-006430-10
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CTKI258A2202
Identifier Type: -
Identifier Source: org_study_id