Clinical trial NCT02053636: 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
Official title: An Open, 3-cohort, Phase II Trial Testing Oral Administration of Lucitanib in Patients With FGFR1-amplified or Non-amplified Estrogen Receptor Positive Metastatic Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Cancer
Lead sponsor: Servier
Sponsor class: INDUSTRY
Collaborators: name: Breast International Group
First posted: 2014-02-04
Enrollment: 76
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of the study is to evaluate the objective response rate (ORR) of single agent lucitanib in metastatic breast cancer patients with FGFR1-amplified, FGFR1-non amplified with 11q amplification, or FGFR1-non amplified without 11q amplification.


Eligibility criteria: Inclusion Criteria:

* Histologically confirmed breast adenocarcinoma.
* 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:

* More than two lines of chemotherapy with or without targeted therapy in the metastatic setting.
* 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.

Primary outcomes:
measure: Objective response rate (ORR)
timeFrame: Every 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: East Melbourne
country: Australia
facility: Peter MacCallum Cancer Centre
city: Westmead
country: Australia
facility: Westmead Hospital
city: Brussels
country: Belgium
facility: Institut Jules Bordet
city: Bruxelles
country: Belgium
facility: Cliniques Universitaires St. Luc Oncology - Breast Clinic
city: Charleroi
country: Belgium
facility: Grand Hôpital de Charleroi Oncologie-Hématologie
city: Leuven
country: Belgium
facility: UZ Leuven Campus Gasthuisberg Dept. of General Medical
city: Namur
country: Belgium
facility: Clinique Sainte-Elisabeth Médecine Interne - Oncologie
city: Montreal
country: Canada
facility: McGill University Department of Oncologie - Clinical Reserach Program
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre
city: Toronto
country: Canada
facility: University Health Network - Princess Margaret Hospital
city: Toulouse
country: France
facility: Institut Claudius Regaud Dpt d'Oncologie Médicale
city: Villejuif Cedex
country: France
facility: Institut Gustave Roussy
city: Villejuif
country: France
facility: Institut Gustave Roussy Dépt d'oncologie - Cancer du sein
city: Essen
country: Germany
facility: Kliniken Essen-Mitte Klinik für Senologie - Brustzentrum
city: Offenbach
country: Germany
facility: KLINIKUM OFFENBACH Klinik für Gynäkologie und Geburtshilfe
city: Offenbach
country: Germany
facility: Klinikum Offenbach
city: Budapest
country: Hungary
facility: Orszagos Onkologiai Intezet Kemoterapia B es Klin.Farm.Oszt.
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Orvos es Egeszsegtudomanyi Centrum Onkologiai Intezet
city: Milano
country: Italy
facility: Istituto Europeo di Oncologia Divisione Sviluppo Nuovi Farmaci per Terapie Innovative
city: Milan
country: Italy
facility: Istituto Europeo di Oncologia
city: Barcelona
country: Spain
facility: H. Valle de Hebrón Servicio de Oncología
city: Madrid
country: Spain
facility: Hospital Universitario Val d'Hebròn
city: Madrid
country: Spain
facility: MD Anderson Cancer Center Unidad de Investigación Clínica
city: Madrid
country: Spain
facility: H. Ramón y Cajal Servicio de Oncología Médica
city: Valencia
country: Spain
facility: H. Clínico de Valencia Servicio de Hematología y oncología Médica
city: Edinburgh
country: United Kingdom
facility: Western General Hospital Edinburgh Cancer Centre
city: London
country: United Kingdom
facility: Royal Marsden Hospital
city: London
country: United Kingdom
facility: The Royal Marsden NHS Trust Dpt of Medicine-Oncology
city: Nottingham
country: United Kingdom
facility: Nottingham University Hospitals NHS Trust Department of Clinical Oncology
Study officials:
affiliation: Institut Gustave Roussy, France
name: Fabrice André, MD
role: STUDY_CHAIR
affiliation: Hospital Universitario Vall d'Hebrón, Spain
name: Javier Cortes, MD
role: STUDY_CHAIR
References:
citation: 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
citation: 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.