Status:
TERMINATED
Dovitinib Plus an Aromatase Inhibitor for Metastatic Breast Cancer
Lead Sponsor:
Georgetown University
Collaborating Sponsors:
Novartis Pharmaceuticals
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
This study is for women with confirmed hormone receptor positive HER-2 negative advanced breast cancer with evidence of disease resistance to an aromatase inhibitor. The purpose of this study is to d...
Detailed Description
This is a Phase I/Phase II open-label single arm trial of dovitinib in combination with anastrozole 1 mg daily, exemestane 25 mg daily, or letrozole 2.5 mg daily. Study subjects will receive the aroma...
Eligibility Criteria
Inclusion
- Female patients with breast cancer either in the primary or metastatic setting
- Tumor must be estrogen receptor and/or progesterone receptor positive and Her-2 negative
- Evidence of disease resistance to an aromatase inhibitor
- ECOG performance status 0 or 1
- Age 18 years or older
- Adequate laboratory values
- Able to give written informed consent
- Measurable disease
- No more than 2 prior chemotherapy regimens in the metastatic setting
- Unlimited prior hormonal therapy in the metastatic setting
- Life expectancy of greater than 3 months
- Post-menopausal
- Tumor must be available for central testing for FGFR1 amplification by FISH/CISH
Exclusion
- Brain metastases
- Another primary malignancy within 3 years prior to starting drug therapy with the exception of adequately treated in-site carcinoma of the uterine cervix or skin cancer
- Chemotherapy within 3 weeks prior to starting study drug or not recovered from side effects of previous therapy
- Administration of nitrosurea or mitomycin-C within 6 weeks prior to starting study drug or not recovered from side effects of such therapy
- Administration of biologic therapy within 6 weeks prior to starting study drug or not recovered from side effects of such therapy
- Radiotherapy within 4 weeks prior to starting study drug or 2 weeks in the case of localized radiotherapy or not recovered from radiotherapy toxicities
- major surgery, open biopsy or significant traumatic injury within 4 weeks prior to starting study drug or a minor procedure, percutaneous biopsy or placement of a vascular access device within 1 week prior to starting study drug or not recovered from side effects of such procedure or injury
- Chronic concomitant bisphosphonate therapy for the prevention of bone metastases. Bisphosphonate/ denosumab therapy for the management of bone metastases or for the treatment of osteoporosis s allowed.
- Impaired cardiac function or clinically significant cardiac disease
- Impairment of GI function or GI disease that may significantly alter the absorption of dovitinib
- Cirrhosis, chronic active hepatitis, or chronic persistent hepatitis
- Known diagnosis of HIV infection
- Anticoagulation treatment with therapeutic doses of warfarin
- Any concurrent severe and/or uncontrolled concomitant medical condition that could cause unacceptable safety risks or compromise compliance with the protocol
- Pregnant or breast-feeding
- Unwilling or unable to comply with the protocol
Key Trial Info
Start Date :
April 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2017
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT01484041
Start Date
April 1 2012
End Date
December 1 2017
Last Update
February 9 2018
Active Locations (1)
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1
Georgetown Lombardi Comprehensive Cancer Center
Washington D.C., District of Columbia, United States, 20007