Professional Documents
Culture Documents
Información: Estado Tipo de Participantes Rangos de Edad
Información: Estado Tipo de Participantes Rangos de Edad
05/09/2022
Estado No iniciado
REGISTRO ESPAÑOL DE ENSAYOS CLINICOS Página 1 de 11
A Study of Abemaciclib (LY2835219) with Abiraterone in Men with Prostate Cancer that has
Spread to Other Parts of the Body and is Expected to Respond to Hormonal Treatment
(Metastatic Hormone-Sensitive Prostate Cancer) (CYCLONE 3).
Información
Área terapéutica
Enfermedades [C] - Neoplasma [C04]
Enfermedad investigada
High-Risk Metastatic Hormone-Sensitive Prostate Cancer
Título Científico
CYCLONE 3: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Abemaciclib in Combination with
Abiraterone plus Prednisone in Men with High-Risk Metastatic Hormone-Sensitive Prostate Cancer
Identificador 2022-500461-28-06 (CTIS)
05/09/2022
Estado No iniciado
REGISTRO ESPAÑOL DE ENSAYOS CLINICOS Página 2 de 11
Justificación
In line with the EMA Appendix on disclosure rules to the ¿Functional specifications for the EU portal and EU
database to be audited- EMA/42176/2014¿, the trial meets the definition of category 2 trial since it is a Phase III trial
assessing a new indication for an authorised IMP to to confirm safety and efficacy
Objetivo Principal
To determine whether adding abemaciclib to abiraterone plus prednisone improves radiographic progression-free
survival (rPFS).
Objetivo Secundario
To evaluate improvements in other clinically relevant efficacy endpoints with the addition of abemaciclib to
abiraterone plus prednisone|To characterize the safety of adding abemaciclib to abiraterone plus prednisone|To
characterize the PK of abemaciclib when administered in combination with abiraterone.|To assess patient-reported
pain and HRQoL
Criterios de Inclusión
Identificador 2022-500461-28-06 (CTIS)
05/09/2022
Estado No iniciado
REGISTRO ESPAÑOL DE ENSAYOS CLINICOS Página 3 de 11
Prostate cancer that has spread to other parts of the body and is expected to respond to hormone treatments
designed to lower testosterone (metastatic hormone-sensitive prostate cancer)|Cancer that has spread to the bones
significantly and/or to the viscera, which are the soft internal organs of the body (for example, the lungs, liver, and the
organs of the digestive system).|Adequate organ function
Criterios de Exclusión
Received prior treatment with abemaciclib or other drugs that work in the same way|Received previous treatment(s)
for metastatic cancer except for up to 3 months of androgen deprivation therapy (ADT) or up to 6 courses of
chemotherapy with ADT|Serious or uncontrolled medical conditions such as certain cardiovascular disorders, active
or chronic liver disease, uncontrolled hypertension, active systemic infections or currently treated for cancer other
than prostate|Prostate cancer that has spread to the central nervous system that is not treated and stable
Calendario
(Última actualización: 05/09/2022)
Fin de Fin prematuro Fin prematuro Fin del ensayo Fin del ensayo
reclutamiento (España) (Global) en España global
Promotor
Contact Person
Katie Wray
003530214232400
wray_katie@lilly.com
Centros
- -
N/A - N/A -
- -
No iniciado (--/--/----)
No iniciado (--/--/----)
L'hospitalet De Llobregat Badajoz
- -
Oncology - Oncology -
- -
- -
- -
- -
- -
- -
N/A - N/A -
- -
No iniciado (--/--/----)
No iniciado (--/--/----)
Sevilla Madrid
- -
Oncology - Oncology -
- -
- -
- -
- -
- -
- -
N/A - N/A -
- -
No iniciado (--/--/----)
No iniciado (--/--/----)
Madrid Valencia
- -
Oncology - Oncology -
- -
- -
- -
- -
- -
-
N/A -
-
No iniciado (--/--/----)
Madrid
-
Oncology -
-
-
-
-
-
Identificador 2022-500461-28-06 (CTIS)
05/09/2022
Estado No iniciado
REGISTRO ESPAÑOL DE ENSAYOS CLINICOS Página 6 de 11
Medicamentos
- -
Principios Activos: N/A Principios Activos: N/A
Experimental Experimental
PREDNISOLONE
TABLET
ORAL
-
Principios Activos: N/A
Experimental
Sin resultados
Identifier 2022-500461-28-06 (CTIS)
05/09/2022
State Not initiated
REGISTRO ESPAÑOL DE ENSAYOS CLINICOS Page 7 of 11
A Study of Abemaciclib (LY2835219) with Abiraterone in Men with Prostate Cancer that has
Spread to Other Parts of the Body and is Expected to Respond to Hormonal Treatment
(Metastatic Hormone-Sensitive Prostate Cancer) (CYCLONE 3).
Information
Therapeutic area
Diseases [C] - Neoplasms [C04]
Investigated Disease
High-Risk Metastatic Hormone-Sensitive Prostate Cancer
Scientific Title
CYCLONE 3: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Abemaciclib in Combination with
Abiraterone plus Prednisone in Men with High-Risk Metastatic Hormone-Sensitive Prostate Cancer
Identifier 2022-500461-28-06 (CTIS)
05/09/2022
State Not initiated
REGISTRO ESPAÑOL DE ENSAYOS CLINICOS Page 8 of 11
Rationale
In line with the EMA Appendix on disclosure rules to the ¿Functional specifications for the EU portal and EU
database to be audited- EMA/42176/2014¿, the trial meets the definition of category 2 trial since it is a Phase III trial
assessing a new indication for an authorised IMP to to confirm safety and efficacy
Main Objective
To determine whether adding abemaciclib to abiraterone plus prednisone improves radiographic progression-free
survival (rPFS).
Primary Endpoints
Radiographic progression-free survival (rPFS) assessed by the investigator.
Secondary Objective
To evaluate improvements in other clinically relevant efficacy endpoints with the addition of abemaciclib to
abiraterone plus prednisone|To characterize the safety of adding abemaciclib to abiraterone plus prednisone|To
characterize the PK of abemaciclib when administered in combination with abiraterone.|To assess patient-reported
pain and HRQoL
Secondary Endpoints
rPFS by blinded, independent, central review (BICR)|Clinical PFS (cPFS)|Castration-resistant prostate cancer
(CRPC)-free survival|Time to symptomatic progression|Time to PSA progression|Time to initiation of new anticancer
therapy|Overall survival (OS).|The safety endpoints evaluated will include, but are not limited to, the following: AEs,
TEAEs, SAEs, clinical laboratory tests, ECGs, vital signs, and physical examinations.|Concentrations of
abemaciclib.|Time to pain progression|Time to deterioration in HRQoL measured by the FACT-P (Physical Well-
Being and PCS scores) and EQ-5D-5L.
Inclusion criteria
Identifier 2022-500461-28-06 (CTIS)
05/09/2022
State Not initiated
REGISTRO ESPAÑOL DE ENSAYOS CLINICOS Page 9 of 11
Prostate cancer that has spread to other parts of the body and is expected to respond to hormone treatments
designed to lower testosterone (metastatic hormone-sensitive prostate cancer)|Cancer that has spread to the bones
significantly and/or to the viscera, which are the soft internal organs of the body (for example, the lungs, liver, and the
organs of the digestive system).|Adequate organ function
Exclusion criteria
Received prior treatment with abemaciclib or other drugs that work in the same way|Received previous treatment(s)
for metastatic cancer except for up to 3 months of androgen deprivation therapy (ADT) or up to 6 courses of
chemotherapy with ADT|Serious or uncontrolled medical conditions such as certain cardiovascular disorders, active
or chronic liver disease, uncontrolled hypertension, active systemic infections or currently treated for cancer other
than prostate|Prostate cancer that has spread to the central nervous system that is not treated and stable
Calendar
(Last Update: 05/09/2022)
Not aported Not aported Not aported Not aported Not aported
Sponsor
Contact Person
Katie Wray
003530214232400
wray_katie@lilly.com
Sites
- -
N/A - N/A -
not initialized (--/--/----)
- -
N/A - N/A -
not initialized (--/--/----)
- -
Sevilla Madrid
- -
Oncology - Oncology -
- -
- -
- -
- -
- -
- -
N/A - N/A -
not initialized (--/--/----)
- -
Madrid Valencia
- -
Oncology - Oncology -
- -
- -
- -
- -
- -
-
N/A -
not initialized (--/--/----)
-
Madrid
-
Oncology -
-
-
-
-
-
Identifier 2022-500461-28-06 (CTIS)
05/09/2022
State Not initiated
REGISTRO ESPAÑOL DE ENSAYOS CLINICOS Page 11 of 11
Medication
Experimental
PREDNISOLONE
TABLET
ORAL
-
Active Principles: N/A
Experimental
No results