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 (FINESSE)

January 2, 2020 updated by: Institut de Recherches Internationales Servier

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

76

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • East Melbourne, Australia
        • Peter MacCallum Cancer Centre
      • Westmead, Australia, 2145
        • Westmead Hospital
  • Belgium
      • Brussels, Belgium, 1000
        • Institut Jules Bordet
      • Bruxelles, Belgium, 1200
        • Cliniques Universitaires St. Luc Oncology - Breast Clinic
      • Charleroi, Belgium, 6000
        • Grand Hôpital de Charleroi Oncologie-Hématologie
      • Leuven, Belgium, 3000
        • UZ Leuven Campus Gasthuisberg Dept. of General Medical
      • Namur, Belgium, 5000
        • Clinique Sainte-Elisabeth Médecine Interne - Oncologie
  • Canada
      • Montreal, Canada, H2W 1S6
        • McGill University Department of Oncologie - Clinical Reserach Program
      • Toronto, Canada, M5G 2M9
        • Princess Margaret Cancer Centre
      • Toronto, Canada, M5G 2M9
        • University Health Network - Princess Margaret Hospital
  • France
      • Toulouse, France, 31059
        • Institut Claudius Regaud Dpt d'Oncologie Médicale
      • Villejuif, France, 94805
        • Institut Gustave Roussy Dépt d'oncologie - Cancer du sein
      • Villejuif Cedex, France, 94805
        • Institut Gustave Roussy
  • Germany
      • Essen, Germany, 45136
        • Kliniken Essen-Mitte Klinik für Senologie - Brustzentrum
      • Offenbach, Germany, 63069
        • Klinikum Offenbach
      • Offenbach, Germany, 63069
        • KLINIKUM OFFENBACH Klinik für Gynäkologie und Geburtshilfe
  • Hungary
      • Budapest, Hungary, 1122
        • Orszagos Onkologiai Intezet Kemoterapia B es Klin.Farm.Oszt.
      • Debrecen, Hungary, 4032
        • Debreceni Egyetem Orvos es Egeszsegtudomanyi Centrum Onkologiai Intezet
  • Italy
      • Milan, Italy, 20141
        • Istituto Europeo di Oncologia
      • Milano, Italy, 20141
        • Istituto Europeo di Oncologia Divisione Sviluppo Nuovi Farmaci per Terapie Innovative
  • Spain
      • Barcelona, Spain, 08035
        • H. Valle de Hebrón Servicio de Oncología
      • Madrid, Spain, 08035
        • Hospital Universitario Val d'Hebròn
      • Madrid, Spain, 28033
        • MD Anderson Cancer Center Unidad de Investigación Clínica
      • Madrid, Spain, 28034
        • H. Ramón y Cajal Servicio de Oncología Médica
      • Valencia, Spain, 46010
        • H. Clínico de Valencia Servicio de Hematología y oncología Médica
  • United Kingdom
      • Edinburgh, United Kingdom, EH4 2XU
        • Western General Hospital Edinburgh Cancer Centre
      • London, United Kingdom, SW3 6JJ
        • Royal Marsden Hospital
      • London, United Kingdom, SW3 6JJ
        • The Royal Marsden NHS Trust Dpt of Medicine-Oncology
      • Nottingham, United Kingdom, NG5 1PB
        • Nottingham University Hospitals NHS Trust Department of Clinical Oncology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Drug: lucitanib

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective response rate (ORR)
Time Frame: Every 8 weeks
Tumor evaluation every 8 weeks throughout the study
Every 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut de Recherches Internationales Servier

Collaborators

Breast International Group

Investigators

  • Study Chair: Fabrice André, MD, Institut Gustave Roussy, France
  • Study Chair: Javier Cortes, MD, Hospital Universitario Vall d'Hebrón, Spain

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2013

Primary Completion (Actual)

March 1, 2017

Study Completion (Actual)

April 4, 2017

Study Registration Dates

First Submitted

January 24, 2014

First Submitted That Met QC Criteria

January 31, 2014

First Posted (Estimate)

February 4, 2014

Study Record Updates

Last Update Posted (Actual)

January 3, 2020

Last Update Submitted That Met QC Criteria

January 2, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CL2-80881-001
  • 2013-000288-10 (EudraCT Number)
  • BIG 2-13 (Other Identifier: BIG)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

After Marketing Authorisation in EEA or US if the study is used for the approval.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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