FGFR1-amplified or non-amplified estrogen receptor positive metastatic breast cancer MedDRA version: 16.1 Level: PT Classification code 10055113 Term: Breast cancer metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 16.1 Level: LLT Classification code 10070575 Term: Estrogen receptor positive breast cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: S80881
Product Code: S80881
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Lucitanib
CAS Number: 1058137-23-7
Current Sponsor code: S80881-2
Other descriptive name: E-3810
Conce
Sponsors
Institut de Recherches Internationales Servier
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Histologically confirmed breast adenocarcinoma. -Prior first-line hormonal 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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 49 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 74
Exclusion criteria
Exclusion criteria: -More than two lines of chemotherapy and two lines of hormonal therapy with or without targeted therapy in the metastatic setting. -Previous treatment with bevacizumab within 3 months of first dose of IMP. -Active central nervous system metastases, cerebral oedema, and/or progressive growth. -Patients with impaired cardiac function. -Patients with history of thrombotic disorders or hereditary risk factors of thromboembolic events -Serum potassium level below LLN -Uncontrolled hypothyroidism. -Pregnant or breastfeeding women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: -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.;Secondary Objective: -To determine the clinical benefit rate (CBR) of single agent lucitanib. -To evaluate the progression-free survival (PFS). -To evaluate the duration of response. -To evaluate the safety of lucitanib. -To evaluate the pharmacokinetics of lucitanib. -To determine the pharmacodynamics profile of lucitanib ;Primary end point(s): -Objective response rate (ORR). ;Timepoint(s) of evaluation of this end point: -at baseline and every 8 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): -Clinical benefit rate (CBR). -Progression-free survival (PFS). -Duration of response. -Safety profile of lucitanib. -PK/PD profile of lucitanib. ;Timepoint(s) of evaluation of this end point: -CBP, PFS, Duration of response: over the study -Safety evaluation: D1, D14, D28, D56, and every 4 weeks -PK evaluation: D14, D56. -PD evaluation : D1, D14 | — |
Countries
Australia, Belgium, Canada, France, Germany, Hungary, Italy, Spain, United Kingdom
Contacts
Public ContactClinical Studies Department
Institut de Recherches Internationales Servier
Outcome results
None listed