E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
metastatic renal cell carcinoma |
CARCINOMA RENAL METASTÁTICO |
|
E.1.1.1 | Medical condition in easily understood language |
Renal Cancer |
CANCER RENAL |
|
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 | LLT |
E.1.2 | Classification code | 10038400 |
E.1.2 | Term | Renal carcinoma stage IV |
E.1.2 | System Organ Class | 100000004864 |
|
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 | 10038399 |
E.1.2 | Term | Renal carcinoma stage III |
E.1.2 | System Organ Class | 100000004864 |
|
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 | 10050076 |
E.1.2 | Term | Metastatic renal carcinoma |
E.1.2 | System Organ Class | 100000004864 |
|
E.1.3 | Condition being studied is a rare disease | Yes |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To compare subject treatment preference of tivozanib versus sunitinib |
COMPARAR LA PREFERENCIA DEL SUJETO EN TRATAMIENTO DE TIVOZANIB VERSUS SUNITINIB |
|
E.2.2 | Secondary objectives of the trial |
To compare overall safety and tolerability in subjects treated with tivozanib and sunitinib. To assess the frequency of dose modifications in subjects treated with tivozanib and sunitinib. To evaluate the Quality of Life (QoL) (including kidney-specific symptoms and fatigue) in subjects treated with tivozanib and sunitinib. |
Para comparar la seguridad global y la tolerabilidad en pacientes tratados con tivozanib y sunitinib. Para evaluar la frecuencia de los ajustes de dosis en pacientes tratados con tivozanib y sunitinib. Para evaluar la calidad de vida (QoL) (incluyendo los riñones específica síntomas y fatiga) en sujetos tratados con sunitinib y tivozanib. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Subjects with unresectable mRCC 2. Histologically or cytologically confirmed RCC of any histology 3. Subjects with or without prior nephrectomy Version 1.1 (see Appendix A). 4. ECOG performance status of 0 or 1 (see Appendix B) 5. Ability to give written informed consent and comply with protocol requirements, including drug treatments and follow-up procedures |
1. Sujetos con CCR irresecable 2. CCR con confirmación histológica o citológica, de cualquier tipo histológico 3. Los sujetos deben haberse sometido a nefrectomía (completa o parcial) 4. Estado funcional conforme a la escala ECOG de 0 o 1 (véase el Anexo B) 5. Capacidad de conceder su consentimiento informado y de cumplir con los requisitos del protocolo, incluidos los tratamientos farmacológicos y los procedimientos de seguimiento |
|
E.4 | Principal exclusion criteria |
1.Any prior systemic therapy (including interleukin-2, interferon-alpha, chemotherapy, bevacizumab, nvestigational or licensed drug that targets vascular endothelial growth factor [VEGF] or VEGF receptors/pathway or are mammalian target of rapamycin [mTOR] inhibitors) for treatment of mRCC 2.Significant hematologic, gastrointestinal, thromboembolic, vascular, bleeding, or coagulation disorders 3. Significant serum chemistry or urinalysis abnormalities. 4. Significant cardiovascular disease, including: ?Symptomatic Left Ventricular Dysfunction or baseline left ventricular ejection fraction (LVEF) of <= lower limit of institutional normal (LLN) ; uncontrolled hypertension; myocardial infarction; severe angina. or unstable angina within 6 months prior to administration of first dose of study drug. ?History of Class III or IV congestive heart failure ?History of serious ventricular arrhythmia ?Cardiac arrhythmias ?Coronary or peripheral artery bypass graft within 6 months of screening. 5.Corrected QT interval (QTc) of > 480 msec using Bazett?s formula. 6. Currently active second primary malignancy |
1. Todo tratamiento sistémico anterior (como interleucina-2, interferón-?, quimioterapia, bevacizumab, fármaco en fase de investigación o con licencia que tenga como diana el VEGF o sus receptores/ruta, o que sean inhibidores de mTOR) para el tratamiento del CCRm 2. Cualquier anomalías hematológicas, vascular, sangrante o de coagulación 3. Cualquier anomalías en los resultados de las pruebas de bioquímica sérica y los análisis de orina 4. Enfermedad cardiovascular importante, entre otras: o disfunción ventricular izquierda sintomática o fracción de eyección ventricular izquierda (FEVI) inicial por ventriculografía nuclear (MUGA) o ecocardiograma (ECO) igual o inferior al límite inferior de la normalidad (LIN) del centro; o infarto de miocardio, angina de pecho grave o angina de pecho inestable en los 6 meses anteriores a la administración de la primera dosis del fármaco del estudio; o antecedentes de insuficiencia cardíaca congestiva de clases III o IV o antecedentes de arritmia ventricular grave o arritmias cardíacas o injerto de derivación (bypass graft) arterial coronario o periférico en los 6 meses anteriores a la selección. 5. Intervalo QT corregido (QTc) > 480 ms mediante la fórmula de Bazett. 6. Segundo cáncer primario activo en ese momento |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Proportion of subjects who prefer tivozanib hydrochloride or sunitinib |
Proporción de sujetos que prefieren clorhidrato tivozanib o sunitinib |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
up to 25 weeks |
hasta 25 semanas |
|
E.5.2 | Secondary end point(s) |
safety and tolerability during the course of the study |
seguridad y tolerabilidad durante el curso del estudio |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
up to 25 weeks |
hasta 25 semanas |
|
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 | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
1.subject preference of tivozanib versus sunitinib 2-QoL |
1-preferencia del sujeto de tivozanib versis sunitinib 2-QoL |
|
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 | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | Yes |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
|
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 6 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 27 |
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 |
Belgium |
France |
Germany |
Italy |
Spain |
United Kingdom |
United States |
|
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
|
"Last Visit, Last Subject" |
ULTIMA VISITA, ULTIMO PACIENTE |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 3 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 6 |
E.8.9.2 | In all countries concerned by the trial days | 0 |