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

Breast Cancer Clinical Trial

— FINESSE  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02053636
• Other study ID #: CL2-80881-001
• Secondary ID: 2013-000288-10BI
• Status: Completed
• Phase: Phase 2
• Start date: December 2013
• Est. completion date: April 4, 2017

Study information

• Verified date: January 2020
• Source: Servier
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: April 4, 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• lucitanib

Locations

Country	Name	City	State
Australia	Peter MacCallum Cancer Centre	East Melbourne
Australia	Westmead Hospital	Westmead
Belgium	Institut Jules Bordet	Brussels
Belgium	Cliniques Universitaires St. Luc Oncology - Breast Clinic	Bruxelles
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
Canada	McGill University Department of Oncologie - Clinical Reserach Program	Montreal
Canada	Princess Margaret Cancer Centre	Toronto
Canada	University Health Network - Princess Margaret Hospital	Toronto
France	Institut Claudius Regaud Dpt d'Oncologie Médicale	Toulouse
France	Institut Gustave Roussy Dépt d'oncologie - Cancer du sein	Villejuif
France	Institut Gustave Roussy	Villejuif Cedex
Germany	Kliniken Essen-Mitte Klinik für Senologie - Brustzentrum	Essen
Germany	Klinikum Offenbach	Offenbach
Germany	KLINIKUM OFFENBACH Klinik für Gynäkologie und Geburtshilfe	Offenbach
Hungary	Orszagos Onkologiai Intezet Kemoterapia B es Klin.Farm.Oszt.	Budapest
Hungary	Debreceni Egyetem Orvos es Egeszsegtudomanyi Centrum Onkologiai Intezet	Debrecen
Italy	Istituto Europeo di Oncologia	Milan
Italy	Istituto Europeo di Oncologia Divisione Sviluppo Nuovi Farmaci per Terapie Innovative	Milano
Spain	H. Valle de Hebrón Servicio de Oncología	Barcelona
Spain	H. Ramón y Cajal Servicio de Oncología Médica	Madrid
Spain	Hospital Universitario Val d'Hebròn	Madrid
Spain	MD Anderson Cancer Center Unidad de Investigación Clínica	Madrid
Spain	H. Clínico de Valencia Servicio de Hematología y oncología Médica	Valencia
United Kingdom	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

Sponsors (2)

Lead Sponsor	Collaborator
Institut de Recherches Internationales Servier	Breast International Group

Countries where clinical trial is conducted

Australia,  Belgium,  Canada,  France,  Germany,  Hungary,  Italy,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective response rate (ORR)	Tumor evaluation every 8 weeks throughout the study	Every 8 weeks

External Links

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