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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.
Sponsor:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00958971
First received: August 11, 2009
Last updated: February 9, 2013
Last verified: February 2013
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Purpose
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: 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:
Genetics Home Reference related topics:
breast cancer
MedlinePlus related topics:
Breast Cancer
U.S. FDA Resources
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 |
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Female presenting with metastatic breast cancer.
- Tumor must have been tested by FISH/CISH for FGFR1 amplification.
- HER2 and HR status must have been determined.
- Patients must have HER2 negative breast cancer.
- Patients must have a documented disease progression as define by RECIST at baseline.
-
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.
- Patients with HR- disease must have received at least one and no more than three lines of chemotherapy in metastatic setting.
Exclusion Criteria:
- 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.
-
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%.
- 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).
- 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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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00958971
Show 38 Study Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00958971
Show 38 Study Locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
| Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
More Information
| Responsible Party: | Novartis Pharmaceuticals |
| ClinicalTrials.gov 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 FGFR1 |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |
ClinicalTrials.gov processed this record on July 17, 2017