E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
FGFR1-amplified or non-amplified estrogen receptor positive metastatic breast cancer |
Cáncer de mama metastásico y receptor estrogénico positivo con FGFR1 amplificado o no |
|
E.1.1.1 | Medical condition in easily understood language |
Breast cancer |
Cáncer de mama |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10055113 |
E.1.2 | Term | Breast cancer metastatic |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10070575 |
E.1.2 | Term | Estrogen receptor positive breast cancer |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
-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. |
-Evaluar la tasa de respuesta objetiva (TRO) de lucitanib como único agente en pacientes con cáncer de mama metastásico con FGFR1- amplificado, FGFR1- no amplificado con amplificación del 11q, o FGFR1- no amplificado sin amplificación del 11q. |
|
E.2.2 | Secondary objectives of the trial |
-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 measure pharmacogenomics and proteomic biomarkers. |
-Determinar la tasa de beneficio clínico (TBC) de lucitanib como único agente . -Evaluar la supervivencia libre de progresión (SLP). -Evaluar la duración de la respuesta. -Evaluar la seguridad de lucitanib. -Evaluar la farmacocinética de lucitanib. -Medir biomarcadores farmacogenómicos y proteómicos. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 use an effective contraception. -Ability to swallow oral capsules. |
-Adenocarcinoma de mama confirmado histológicamente. -Terapia hormonal de primera línea previa para enfermedad metastásica. -Progresión de la enfermedad demostrada por radiología o mediante evaluación clínica. -Mujer, edad ? 18 años. -Esperanza de vida > 3 meses. -Función ventricular izquierda normal. -Valores renales, hepáticos y hematológicos adecuados. -Para las mujeres en edad fértil, una prueba de embarazo negativa previas al inicio de la medicación del estudio y disposición para utilizar un método anticonceptivo eficaz. -Capacidad para tragar las cápsulas orales. |
|
E.4 | Principal 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. -Uncontrolled hypothyroidism. -Pregnant or breastfeeding women. |
-Más de dos líneas de quimioterapia y dos líneas de terapia hormonal con o sin terapia dirigida para el cáncer metastásico. -Tratamiento previo con bevacizumab en los 3 meses previos a la primera dosis del MEI. -Metástasis activa en el sistema nervioso central, evidenciada por síntomas clínicos, edema cerebral, y/o crecimiento progresivo. -Pacientes con función cardiaca dañada. -Hipotiroidismo no controlado. -Mujeres embarazadas o en periodo de lactancia. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
-Objective response rate (ORR). |
-Tasa de respuesta objetiva (TRO) |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
-at baseline and every 8 weeks. |
-al inicio y cada 8 semanas |
|
E.5.2 | Secondary end point(s) |
-Clinical benefit rate (CBR). -Progression-free survival (PFS). -Duration of response. -Safety profile of lucitanib. -PK profile of lucitanib. |
-Tasa de beneficio clínico (TBC). -Supervivencia libre de progresión (SLP). -Duración de la respuesta. -Perfil de seguridad de lucitanib. -Farmacocinética de lucitanib. |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
-CBP, SLP, Duration of response: over the study -Safety evaluation: D1, D14, D28, D56, and every 4 weeks -PK evaluation: D14, D56. |
-TBC, PFS, duración de respuesta: durante el estudio -Evaluación de seguridad: D1, D14, D28, D56, y cada 4 semanas -Evaluación PK: D14, D56. |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | Yes |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.2.4 | Number of treatment arms in the trial | 3 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 22 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Australia |
Belgium |
Canada |
France |
Germany |
Italy |
Spain |
United Kingdom |
|
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
LVLS |
Última visita del último paciente |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 5 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 5 |
E.8.9.2 | In all countries concerned by the trial days | 0 |