A Phase II Trial Testing Oral Administration of Lucitanib in Patients With Fibroblast Growth Factor Receptor (FGFR)1-amplified or Non-amplified Estrogen Receptor Positive Metastatic Breast Cancer
NCT ID: NCT02053636
Last Updated: 2024-07-25
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
76 participants
INTERVENTIONAL
2013-12-31
2017-04-04
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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lucitanib
Hard gelatine capsules of 2,5, 5 and 10 mg or film coated tablets of 5 and 7,5 mg.
5 to 10 mg orally on a daily basis until unacceptable toxicity according to the investigator, disease progression or withdrawal of consent
lucitanib
Interventions
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lucitanib
Eligibility Criteria
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Inclusion Criteria
* Presence of an accessible metastatic lesion for biopsy or at least one archived metastatic tumour sample.
* Prior first-line systemic therapy in the metastatic setting.
* Demonstrated progression of disease by radiological or clinical assessment.
* Female patient, aged ≥18 years old.
* Estimated life expectancy \>3 months.
* Normal Left ventricular function
* Adequate haematological, hepatic and renal functions.
* For women with childbearing potential, a negative pregnancy test prior to initiation of the study drug and willingness to use an effective contraception.
* Ability to swallow oral capsules or tablets.
Exclusion Criteria
* Previous treatment with bevacizumab within 3 months of first dose of Investigational Medicinal Product.
* Active central nervous system metastases, cerebral oedema, and/or progressive growth.
* Patients with impaired cardiac function.
* Uncontrolled arterial hypertension
* Patients with history of thrombotic disorders or hereditary risk factors of thromboembolic events
* Serum potassium level below Lower Limit of Normal
* Uncontrolled hypothyroidism.
* Pregnant or breastfeeding women.
18 Years
FEMALE
No
Sponsors
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Breast International Group
OTHER
Institut de Recherches Internationales Servier
OTHER
Responsible Party
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Principal Investigators
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Fabrice André, MD
Role: STUDY_CHAIR
Institut Gustave Roussy, France
Javier Cortes, MD
Role: STUDY_CHAIR
Hospital Universitario Vall d'Hebrón, Spain
Locations
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Peter MacCallum Cancer Centre
East Melbourne, , Australia
Westmead Hospital
Westmead, , Australia
Institut Jules Bordet
Brussels, , Belgium
Cliniques Universitaires St. Luc Oncology - Breast Clinic
Brussels, , Belgium
Grand Hôpital de Charleroi Oncologie-Hématologie
Charleroi, , Belgium
UZ Leuven Campus Gasthuisberg Dept. of General Medical
Leuven, , Belgium
Clinique Sainte-Elisabeth Médecine Interne - Oncologie
Namur, , Belgium
McGill University Department of Oncologie - Clinical Reserach Program
Montreal, , Canada
Princess Margaret Cancer Centre
Toronto, , Canada
University Health Network - Princess Margaret Hospital
Toronto, , Canada
Institut Claudius Regaud Dpt d'Oncologie Médicale
Toulouse, , France
Institut Gustave Roussy Dépt d'oncologie - Cancer du sein
Villejuif, , France
Institut Gustave Roussy
Villejuif, , France
Kliniken Essen-Mitte Klinik für Senologie - Brustzentrum
Essen, , Germany
KLINIKUM OFFENBACH Klinik für Gynäkologie und Geburtshilfe
Offenbach, , Germany
Klinikum Offenbach
Offenbach, , Germany
Orszagos Onkologiai Intezet Kemoterapia B es Klin.Farm.Oszt.
Budapest, , Hungary
Debreceni Egyetem Orvos es Egeszsegtudomanyi Centrum Onkologiai Intezet
Debrecen, , Hungary
Istituto Europeo di Oncologia
Milan, , Italy
Istituto Europeo di Oncologia Divisione Sviluppo Nuovi Farmaci per Terapie Innovative
Milan, , Italy
H. Valle de Hebrón Servicio de Oncología
Barcelona, , Spain
Hospital Universitario Val d'Hebròn
Madrid, , Spain
MD Anderson Cancer Center Unidad de Investigación Clínica
Madrid, , Spain
H. Ramón y Cajal Servicio de Oncología Médica
Madrid, , Spain
H. Clínico de Valencia Servicio de Hematología y oncología Médica
Valencia, , Spain
Western General Hospital Edinburgh Cancer Centre
Edinburgh, , United Kingdom
Royal Marsden Hospital
London, , United Kingdom
The Royal Marsden NHS Trust Dpt of Medicine-Oncology
London, , United Kingdom
Nottingham University Hospitals NHS Trust Department of Clinical Oncology
Nottingham, , United Kingdom
Countries
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References
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Hui R, Pearson RM, Cortes Castan J, Campbell C, Poirot C, Azim HA Jr, Fumagalli R, Lambertini M, Daly F, Arahmani A, Garcia-Perez J, Aftimos PG, Bedard P, Xuereb RG, Loibl S, Loi U, Pierrat MJ, Turner NC, Andre F, Curigliano G. Ann Oncol. 2018 Oct;29(Supplement 8):VIII93. doi: https://doi.org/10.1093/annonc/mdy272.281
Liao M, Zhou J, Wride K, Lepley D, Cameron T, Sale M, Xiao J. Population Pharmacokinetic Modeling of Lucitanib in Patients with Advanced Cancer. Eur J Drug Metab Pharmacokinet. 2022 Sep;47(5):711-723. doi: 10.1007/s13318-022-00773-w. Epub 2022 Jul 18.
Other Identifiers
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2013-000288-10
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
BIG 2-13
Identifier Type: OTHER
Identifier Source: secondary_id
CL2-80881-001
Identifier Type: -
Identifier Source: org_study_id
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