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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)
Servier Protocol Code:
CL2-80881-001
Sponsor:
Institut de Recherches Internationales Servier
Clinicaltrials.gov Identifier:
NCT02053636
EudraCT Number:
2013-000288-10
Find a recruiting site
How to participate in this study
If you think you are eligible for this study (see
below), you can identify the location closest to you and contact them directly. If you can’t find a location close to you, please contact Institut de Recherches Internationales Servier (I.R.I.S.)
eligibility criteria
Researchers look for people who fit a certain decription, called eligibility criteria. These include inclusion criteria and exclusion criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Name:
Institut de Recherches Internationales Servier, Département des études cliniques
Phone number:
+33 1 55 72 60 00
The study has 29 locations
Study description
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.
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
Results
English (USA)Conditions
Breast Cancer
Interventions / Treatments
The treatment(s) given to the participants in the study.
- lucitanib
Other study id numbers
Other identification numbers the study may be known by.
- CL2-80881-001
Eligibility Criteria
Researchers look for people who fit a certain decription, called eligibility criteria. These include inclusion criteria and exclusion criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligible age for the study
18 years and older
(Adult, Older Adult)
Sex
FemaleAccepts Healthy Volunteers
No- * 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.
- * 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.
How is the study designed?
Allocation
How participants are assigned to different groups. Allocation can be random (randomized) or predetermined (non-randomized). Randomized means that participants are assigned at random to their participant group / arm.
Interventional study model
How treatments are given and tested in a study.
Single Group
A single group study design involves studying one group of participants who all receive the same treatment. Researchers observe the group's results to understand the effects of the treatment.
Participant Group / Arm
A set of participants in the study who receive the same treatment or intervention.
Intervention / Treatment
The treatment(s) given to the participants in the study.
Participant Group / Arm
A set of participants in the study who receive the same treatment or intervention.
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
Intervention / Treatment
The treatment(s) given to the participants in the study.
Drug:
lucitanib
Keywords
Additional Relevant MeSH Terms Glioma
Breast Neoplasms