Breast CancerPhase 2FINESSENCT02053636
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
A Phase 2 study testing lucitanib in people with Breast Cancer, run by Institut de Recherches Internationales Servier at 29 sites in 9 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- lucitanib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 29 sitesin 9 countries
- Study dates
- Dec 2013to 4 Apr 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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
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- Serum potassium level below Lower Limit of Normal
- Uncontrolled hypothyroidism.
- Pregnant or breastfeeding women.
Trial locations and contacts
29 sites in 9 countries.
29 sites in 9 countries
Belgium5 sites
Institut Jules Bordet
Brussels, 1000
Cliniques Universitaires St. Luc Oncology - Breast Clinic
Brussels, 1200
Grand Hôpital de Charleroi Oncologie-Hématologie
Charleroi, 6000
UZ Leuven Campus Gasthuisberg Dept. of General Medical
Leuven, 3000
Clinique Sainte-Elisabeth Médecine Interne - Oncologie
Namur, 5000
Spain5 sites
H. Valle de Hebrón Servicio de Oncología
Barcelona, 08035
Hospital Universitario Val d'Hebròn
Madrid, 08035
MD Anderson Cancer Center Unidad de Investigación Clínica
Madrid, 28033
H. Ramón y Cajal Servicio de Oncología Médica
Madrid, 28034
H. Clínico de Valencia Servicio de Hematología y oncología Médica
Valencia, 46010
United Kingdom4 sites
Western General Hospital Edinburgh Cancer Centre
Edinburgh, EH4 2XU
Royal Marsden Hospital
London, SW3 6JJ
The Royal Marsden NHS Trust Dpt of Medicine-Oncology
London, SW3 6JJ
Nottingham University Hospitals NHS Trust Department of Clinical Oncology
Nottingham, NG5 1PB
Canada3 sites
McGill University Department of Oncologie - Clinical Reserach Program
Montreal, H2W 1S6
Princess Margaret Cancer Centre
Toronto, M5G 2M9
University Health Network - Princess Margaret Hospital
Toronto, M5G 2M9
France3 sites
Institut Claudius Regaud Dpt d'Oncologie Médicale
Toulouse, 31059
Institut Gustave Roussy Dépt d'oncologie - Cancer du sein
Villejuif, 94805
Institut Gustave Roussy
Villejuif, 94805
Germany3 sites
Kliniken Essen-Mitte Klinik für Senologie - Brustzentrum
Essen, 45136
KLINIKUM OFFENBACH Klinik für Gynäkologie und Geburtshilfe
Offenbach, 63069
Klinikum Offenbach
Offenbach, 63069
Australia2 sites
Peter MacCallum Cancer Centre
East Melbourne
Westmead Hospital
Westmead, 2145
Hungary2 sites
Orszagos Onkologiai Intezet Kemoterapia B es Klin.Farm.Oszt.
Budapest, 1122
Debreceni Egyetem Orvos es Egeszsegtudomanyi Centrum Onkologiai Intezet
Debrecen, 4032
Italy2 sites
Istituto Europeo di Oncologia
Milan, 20141
Istituto Europeo di Oncologia Divisione Sviluppo Nuovi Farmaci per Terapie Innovative
Milan, 20141
About this study
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
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.
- Conditions
- Breast Cancer
- Being tested
- lucitanib
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lucitanibDrug
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: lucitanib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR)
Tumor evaluation every 8 weeks throughout the study
Measured: Every 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2014 (estimated)
- Study startDec 2013
- Primary completionMar 2017
- Study completion4 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut de Recherches Internationales Servier
- Sponsor type
- University, hospital or other
- Collaborators
- Breast International Group
- Responsible party
- Sponsor
- Investigators
- Fabrice André, MD, Study chair, Institut Gustave Roussy, FranceJavier Cortes, MD, Study chair, Hospital Universitario Vall d'Hebrón, Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02053636
- Sponsor's protocol ID
- CL2-80881-001
- Other IDs
- 2013-000288-10, BIG 2-13
- Acronym
- FINESSE
- Status last verified
- Jul 2024
- First submitted
- 24 Jan 2014
- Last updated
- 25 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: 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.
Publications
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
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.
PubMed 35844029
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02053636
- Acronym / sponsor ID
- FINESSE / CL2-80881-001
- Conditions
- Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Institut de Recherches Internationales ServierUniversity, hospital or other
- Collaborators
- Breast International Group
- Study start
- Dec 2013
- Primary completion
- Mar 2017 (actual)
- Study completion
- 4 Apr 2017 (actual)
- First posted
- 4 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| lucitanib | Experimental | Drug: lucitanibHard 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| lucitanib | Drug | lucitanib |
Primary outcome
Objective response rate (ORR)
Time frame: Every 8 weeks
Tumor evaluation every 8 weeks throughout the study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2024.
- BackgroundHui 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: PubMed 35844029Liao 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fabrice André, MD study chair
Institut Gustave Roussy, France
Javier Cortes, MD study chair
Hospital Universitario Vall d'Hebrón, Spain
29 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing lucitanib in people with Breast Cancer, run by Institut de Recherches Internationales Servier at 29 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites in Belgium, Spain, United Kingdom, Canada, France and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (ORR) (time frame: Every 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02053636, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2024.