NCT02053636

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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
76

participants targeted

Target at P50-P75 for phase_2 breast-cancer

Timeline
Completed

Started Dec 2013

Geographic Reach
9 countries

29 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 24, 2014

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 4, 2014

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 4, 2017

Completed
Last Updated

July 25, 2024

Status Verified

July 1, 2024

Enrollment Period

3.2 years

First QC Date

January 24, 2014

Last Update Submit

July 24, 2024

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • Objective response rate (ORR)

    Tumor evaluation every 8 weeks throughout the study

    Every 8 weeks

Study Arms (1)

lucitanib

EXPERIMENTAL

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

Drug: lucitanib

Interventions

lucitanibDRUG
lucitanib

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (29)

Peter MacCallum Cancer Centre

East Melbourne, Australia

Location

Westmead Hospital

Westmead, 2145, Australia

Location

Institut Jules Bordet

Brussels, 1000, Belgium

Location

Cliniques Universitaires St. Luc Oncology - Breast Clinic

Brussels, 1200, Belgium

Location

Grand Hôpital de Charleroi Oncologie-Hématologie

Charleroi, 6000, Belgium

Location

UZ Leuven Campus Gasthuisberg Dept. of General Medical

Leuven, 3000, Belgium

Location

Clinique Sainte-Elisabeth Médecine Interne - Oncologie

Namur, 5000, Belgium

Location

McGill University Department of Oncologie - Clinical Reserach Program

Montreal, H2W 1S6, Canada

Location

Princess Margaret Cancer Centre

Toronto, M5G 2M9, Canada

Location

University Health Network - Princess Margaret Hospital

Toronto, M5G 2M9, Canada

Location

Institut Claudius Regaud Dpt d'Oncologie Médicale

Toulouse, 31059, France

Location

Institut Gustave Roussy Dépt d'oncologie - Cancer du sein

Villejuif, 94805, France

Location

Institut Gustave Roussy

Villejuif, 94805, France

Location

Kliniken Essen-Mitte Klinik für Senologie - Brustzentrum

Essen, 45136, Germany

Location

KLINIKUM OFFENBACH Klinik für Gynäkologie und Geburtshilfe

Offenbach, 63069, Germany

Location

Klinikum Offenbach

Offenbach, 63069, Germany

Location

Orszagos Onkologiai Intezet Kemoterapia B es Klin.Farm.Oszt.

Budapest, 1122, Hungary

Location

Debreceni Egyetem Orvos es Egeszsegtudomanyi Centrum Onkologiai Intezet

Debrecen, 4032, Hungary

Location

Istituto Europeo di Oncologia

Milan, 20141, Italy

Location

Istituto Europeo di Oncologia Divisione Sviluppo Nuovi Farmaci per Terapie Innovative

Milan, 20141, Italy

Location

H. Valle de Hebrón Servicio de Oncología

Barcelona, 08035, Spain

Location

Hospital Universitario Val d'Hebròn

Madrid, 08035, Spain

Location

MD Anderson Cancer Center Unidad de Investigación Clínica

Madrid, 28033, Spain

Location

H. Ramón y Cajal Servicio de Oncología Médica

Madrid, 28034, Spain

Location

H. Clínico de Valencia Servicio de Hematología y oncología Médica

Valencia, 46010, Spain

Location

Western General Hospital Edinburgh Cancer Centre

Edinburgh, EH4 2XU, United Kingdom

Location

Royal Marsden Hospital

London, SW3 6JJ, United Kingdom

Location

The Royal Marsden NHS Trust Dpt of Medicine-Oncology

London, SW3 6JJ, United Kingdom

Location

Nottingham University Hospitals NHS Trust Department of Clinical Oncology

Nottingham, NG5 1PB, United Kingdom

Location

Related Publications (2)

  • 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

    BACKGROUND

  • 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.

    PMID: 35844029BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Interventions

E-3810

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Fabrice André, MD

    Institut Gustave Roussy, France

    STUDY CHAIR

  • Javier Cortes, MD

    Hospital Universitario Vall d'Hebrón, Spain

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 24, 2014

First Posted

February 4, 2014

Study Start

December 1, 2013

Primary Completion

March 1, 2017

Study Completion

April 4, 2017

Last Updated

July 25, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will share

Researchers can ask for a study protocol, patient-level and/or study-level clinical trial data including clinical study reports (CSRs). They can ask all interventional clinical studies: * submitted for new medicines and new indications approved after 1 January 2014 in the European Economic Area (EEA) or the United States (US). * Where Servier or an affiliate are the Marketing Authorization Holders (MAH). The date of the first Marketing Authorization of the new medicine (or the new indication) in one of the EEA Member States will be considered within this scope.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
After Marketing Authorisation in EEA or US if the study is used for the approval.
Access Criteria
Researchers should register on Servier Data Portal and fill in the research proposal form. This form in four parts should be fully documented. The Research Proposal Form will not be reviewed until all mandatory fields are completed.
More information

Locations

BE(5)GB(4)IT(2)CA(3)HU(2)AU(2)FR(3)DE(3)ES(5)