Identificador 2022-500461-28-06 (CTIS)
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).
Estado Tipo de Participantes Rangos de Edad
No iniciado No aportado Mayores de 64 , Adultos
Género Fases Participantes esperados
Hombres Fase III 912
Resultados Bajo nivel intervención Enfermedad rara
Sin resultados No No
Cobertura geográfica Ámbitos del ensayo Tipo de promotor
Multicéntrico internacional tratamiento, seguridad, eficacia, Comercial
farmacocinética, farmacogenómica
Información
Identificador Cod. Protocolo
2022-500461-28-06 (CTIS) I3Y-MC-JPEG
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).
Variables de Evaluación Primaria
Radiographic progression-free survival (rPFS) assessed by the investigator.
Momentos temporales de evaluación primaria
No aportado
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
Variables de Evaluación Secundaria
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.
Momentos temporales de evaluación secundaria
No aportado
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)
Autorización Inicio de Inclusión Interrumpido Reiniciado
Ensayo Primer Paciente
05/09/2022 No aportado No aportado
No aportado No aportado
Fin de Fin prematuro Fin prematuro Fin del ensayo Fin del ensayo
reclutamiento (España) (Global) en España global
No aportado No aportado No aportado No aportado No aportado
Identificador 2022-500461-28-06 (CTIS)
05/09/2022
Estado No iniciado
REGISTRO ESPAÑOL DE ENSAYOS CLINICOS Página 4 de 11
Promotor
Eli Lilly Cork Limited Ireland
Island House Eastgate RoadEastgate Business ParkLittle Island
Contact Person
Katie Wray
003530214232400
[email protected]
Monetary support: N/A
Identificador 2022-500461-28-06 (CTIS)
05/09/2022
Estado No iniciado
REGISTRO ESPAÑOL DE ENSAYOS CLINICOS Página 5 de 11
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
ABIRATERONE ACETATE PREDNISONE
FILM-COATED TABLET TABLET
ORAL ORAL
- -
Principios Activos: N/A Principios Activos: N/A
Experimental Experimental
Verzenios 50 mg film-coated tablets Placebo to Match LY2835219 50-mg Tablets
FILM-COATED TABLET N/A
ORAL
Código ATC: L01EF03 - ABEMACICLIB
-
Principios Activos: N/A
Principios Activos: N/A
Experimental
Huérfano 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).
State Type of participants Age Ranges
Not initiated Not provided Older than 64 , Adults
Gender Phases Expected Participants
Men Phase III 912
Results Low level of intervention Rare disease
No results No No
Geographic coverage Areas of the study Sponsor type
International multicenter treatment, safety, effectiveness, Commercial
pharmacokinetics, pharmacogenomics
Information
Identifier Protocol Code
2022-500461-28-06 (CTIS) I3Y-MC-JPEG
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.
Temporary moments of secondary assessment
Not provided
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.
Temporary moments of secondary assessment
Not provided
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)
Authorization Start of Trial First patient Halted Restarted
inclusion
05/09/2022 Not aported Not aported Not aported
Not aported
End of Premature end Premature End Trial end Trial end
recruitment (Spain) (Global) (Spain) (Global)
Not aported Not aported Not aported Not aported Not aported
Sponsor
Eli Lilly Cork Limited Ireland
Island House Eastgate RoadEastgate Business ParkLittle Island
Contact Person
Katie Wray
003530214232400
[email protected]
Monetary support: N/A
Identifier 2022-500461-28-06 (CTIS)
05/09/2022
State Not initiated
REGISTRO ESPAÑOL DE ENSAYOS CLINICOS Page 10 of 11
Sites
- -
N/A - N/A -
not initialized (--/--/----)
not initialized (--/--/----)
- -
L'hospitalet De Llobregat Badajoz
- -
Oncology - Oncology -
- -
- -
- -
- -
- -
- -
N/A - N/A -
not initialized (--/--/----)
not initialized (--/--/----)
- -
Sevilla Madrid
- -
Oncology - Oncology -
- -
- -
- -
- -
- -
- -
N/A - N/A -
not initialized (--/--/----)
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
ABIRATERONE ACETATE PREDNISONE
FILM-COATED TABLET TABLET
ORAL ORAL
Active Principles: N/A
-
Experimental Active Principles: N/A
Experimental
Verzenios 50 mg film-coated tablets Placebo to Match LY2835219 50-mg Tablets
FILM-COATED TABLET N/A
ORAL
ATC code: L01EF03 - ABEMACICLIB
-
Active Principles: N/A
Active Principles: N/A
Experimental
Orphan Experimental
PREDNISOLONE
TABLET
ORAL
-
Active Principles: N/A
Experimental
No results
