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

Phase 2

Completed

• Conditions: Breast Cancer
• Interventions: Drug: lucitanib

• Registration Number: NCT02053636
• Lead Sponsor: Institut de Recherches Internationales Servier

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-12
• Study First Submitted: 2014-01-24
• Study First Submitted QC: 2014-01-31
• Study First Posted: 2014-02-04
• Primary Completion: 2017-03
• Study Completion: 2017-04-04
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-24
• Last Update Posted: 2024-07-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 76

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
lucitanib	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

Primary Outcome Measures

Name	Time	Method
Objective response rate (ORR)	Every 8 weeks	Tumor evaluation every 8 weeks throughout the study

Trial Locations

Locations (29)

Institut Claudius Regaud Dpt d'Oncologie Médicale; 🇫🇷 Toulouse, France

Institut Gustave Roussy Dépt d'oncologie - Cancer du sein; 🇫🇷 Villejuif, France

Institut Jules Bordet; 🇧🇪 Brussels, Belgium

Westmead Hospital; 🇦🇺 Westmead, Australia

Cliniques Universitaires St. Luc Oncology - Breast Clinic; 🇧🇪 Bruxelles, Belgium

Peter MacCallum Cancer Centre; 🇦🇺 East Melbourne, Australia

The Royal Marsden NHS Trust Dpt of Medicine-Oncology; 🇬🇧 London, United Kingdom

Grand Hôpital de Charleroi Oncologie-Hématologie; 🇧🇪 Charleroi, Belgium

UZ Leuven Campus Gasthuisberg Dept. of General Medical; 🇧🇪 Leuven, Belgium

Royal Marsden Hospital; 🇬🇧 London, United Kingdom

Nottingham University Hospitals NHS Trust Department of Clinical Oncology; 🇬🇧 Nottingham, United Kingdom

McGill University Department of Oncologie - Clinical Reserach Program; 🇨🇦 Montreal, Canada

Princess Margaret Cancer Centre; 🇨🇦 Toronto, Canada

University Health Network - Princess Margaret Hospital; 🇨🇦 Toronto, Canada

H. Clínico de Valencia Servicio de Hematología y oncología Médica; 🇪🇸 Valencia, Spain

Kliniken Essen-Mitte Klinik für Senologie - Brustzentrum; 🇩🇪 Essen, Germany

Clinique Sainte-Elisabeth Médecine Interne - Oncologie; 🇧🇪 Namur, Belgium

Istituto Europeo di Oncologia; 🇮🇹 Milan, Italy

KLINIKUM OFFENBACH Klinik für Gynäkologie und Geburtshilfe; 🇩🇪 Offenbach, Germany

Institut Gustave Roussy; 🇫🇷 Villejuif Cedex, France

Klinikum Offenbach; 🇩🇪 Offenbach, Germany

Istituto Europeo di Oncologia Divisione Sviluppo Nuovi Farmaci per Terapie Innovative; 🇮🇹 Milano, Italy

Orszagos Onkologiai Intezet Kemoterapia B es Klin.Farm.Oszt.; 🇭🇺 Budapest, Hungary

Debreceni Egyetem Orvos es Egeszsegtudomanyi Centrum Onkologiai Intezet; 🇭🇺 Debrecen, Hungary

H. Valle de Hebrón Servicio de Oncología; 🇪🇸 Barcelona, Spain

Hospital Universitario Val d'Hebròn; 🇪🇸 Madrid, Spain

H. Ramón y Cajal Servicio de Oncología Médica; 🇪🇸 Madrid, Spain

MD Anderson Cancer Center Unidad de Investigación Clínica; 🇪🇸 Madrid, Spain

Western General Hospital Edinburgh Cancer Centre; 🇬🇧 Edinburgh, United Kingdom