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| Sponsor: | Novartis Pharmaceuticals |
|---|---|
| Information provided by: | Novartis |
| ClinicalTrials.gov Identifier: | NCT00958971 |
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 |
|---|---|---|
|
Carcinoma Breast Stage IV |
Drug: TKI258 |
Phase II |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group 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 |
| Enrollment: | 81 |
| Study Start Date: | July 2009 |
| 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 |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients with HR+ disease:
Exclusion Criteria:
Impaired cardiac function or clinically significant cardiac diseases, including any of the following:
Other protocol-defined inclusion/exclusion criteria may apply
Contacts and Locations
Show 51 Study Locations| Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
More Information
| Responsible Party: | External Affairs, Novartis Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00958971 History of Changes |
| Other Study ID Numbers: | CTKI258A2202, EUDRACT number 2008-006430-10 |
| Study First Received: | August 11, 2009 |
| Last Updated: | March 10, 2011 |
| Health Authority: | United States: Food and Drug Administration; Canada: Health Canada; Finland: Finnish Medicines Agency; France: Afssaps - French Health Products Safety Agency; Italy: Ministry of Health; Spain: Ministry of Health; Taiwan: Department of Health; United Kingdom: Medicines and Healthcare Products Regulatory Agency |
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Breast cancer HER2 negative FGFR1 |
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Breast Neoplasms Carcinoma Neoplasms by Site Neoplasms |
Breast Diseases Skin Diseases Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type |