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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

Sponsor
Institut de Recherches Internationales Servier (Other)
Overall Status
Completed
CT.gov ID
NCT02053636
Collaborator
Breast International Group (Other)
76
Enrollment
29
Locations
1
Arm
40.1
Duration (Months)
2.6
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
76 participants
Allocation:
N/A
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 :
Dec 1, 2013
Actual Primary Completion Date :
Mar 1, 2017
Actual Study Completion Date :
Apr 4, 2017

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Objective response rate (ORR) [Every 8 weeks]

    Tumor evaluation every 8 weeks throughout the study

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

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

Sponsors and Collaborators

  • Institut de Recherches Internationales 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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Institut de Recherches Internationales Servier
ClinicalTrials.gov Identifier:
NCT02053636
Other Study ID Numbers:
  • CL2-80881-001
  • 2013-000288-10
  • BIG 2-13
First Posted:
Feb 4, 2014
Last Update Posted:
Jan 3, 2020
Last Verified:
Jan 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Additional relevant MeSH terms:
Breast Neoplasms

Study Results

No Results Posted as of Jan 3, 2020