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Trial record 3 of 6 for:    FINESSE

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)

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ClinicalTrials.gov Identifier: NCT02053636
Recruitment Status : Completed
First Posted : February 4, 2014
Last Update Posted : April 26, 2018
Sponsor:
Collaborator:
Breast International Group
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: lucitanib Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 76 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : December 2013
Actual Primary Completion Date : March 2017
Actual Study Completion Date : April 4, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Estrogens

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



Primary Outcome Measures :
  1. Objective response rate (ORR) [ Time Frame: Every 8 weeks ]
    Tumor evaluation every 8 weeks throughout the study



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02053636


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

Additional Information:
Responsible Party: Servier
ClinicalTrials.gov Identifier: NCT02053636     History of Changes
Other Study ID Numbers: CL2-80881-001
2013-000288-10 ( EudraCT Number )
BIG 2-13 ( Other Identifier: BIG )
First Posted: February 4, 2014    Key Record Dates
Last Update Posted: April 26, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (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.
URL: http://clinicaltrials.servier.com

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs