Clinical Trials Register

Summary
EudraCT Number:	2018-002587-28
Sponsor's Protocol Code Number:	BGB-290-202
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2019-05-08
Trial results	View results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

Spain - AEMPS

A.2

EudraCT number

2018-002587-28

A.3

Full title of the trial

A Phase 2, Open-Label, Single-Arm Study of Pamiparib (BGB-290) for the Treatment of Patients with Metastatic Castration-Resistant Prostate Cancer (mCRPC) with Homologous Recombination Deficiency (HRD)

Estudio de fase 2, abierto y de un solo brazo de pamiparib (BGB-290) para el tratamiento de pacientes con cáncer de próstata metastásico resistente a la castración (CPRCm) con deficiencia de recombinación homóloga (DRH)

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

A.4.1

Sponsor's protocol code number

BGB-290-202

A.5.2

US NCT (ClinicalTrials.gov registry) number

NCT03712930

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	BeiGene, Ltd.
B.1.3.4	Country	United States
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	BeiGene, Ltd
B.4.2	Country	United States
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	BeiGene, Ltd.
B.5.2	Functional name of contact point	Clinical Trial Information Email
B.5.3	Address:
B.5.3.1	Street Address	2929 Campus Drive, Suite 300
B.5.3.2	Town/ city	San Mateo
B.5.3.3	Post code	94403
B.5.3.4	Country	United States
B.5.6	E-mail	clinicaltrials@beigene.com

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	No
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Pamiparib
D.3.2	Product code	BGB-290
D.3.4	Pharmaceutical form	Capsule
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Pamiparib
D.3.9.3	Other descriptive name	BGB-290
D.3.9.4	EV Substance Code	SUB188812
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	20
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 2
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	No
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Pamiparib
D.3.2	Product code	BGB-290
D.3.4	Pharmaceutical form	Capsule
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Pamiparib
D.3.9.3	Other descriptive name	BGB-290
D.3.9.4	EV Substance Code	SUB188812
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	60
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Patients with metastatic castration-resistant prostate cancer (mCRPC) positive for circulating tumor cells (CTC) with homologous recombination
deficiency

Pacientes con cáncer de próstata metastásico resistente a la
castración (CPRCm) positivo para células tumorales circulantes (CTC)con deficiencia de recombinación homóloga (DRH)

E.1.1.1

Medical condition in easily understood language

Patients with metastatic castration-resistant prostate cancer

Pacientes con cáncer de próstata metastásico resistente a
la castración

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	20.0
E.1.2	Level	PT
E.1.2	Classification code	10036909
E.1.2	Term	Prostate 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	20.0
E.1.2	Level	LLT
E.1.2	Classification code	10076506
E.1.2	Term	Castration-resistant prostate 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

E.2 Objective of the trial

E.2.1

Main objective of the trial

To evaluate the efficacy of pamiparib in patients with metastatic castration-resistant prostate cancer (mCRPC) positive for circulating tumor cells (CTC) with homologous recombination deficiency (CTC-HRD-positive; per Epic Sciences assay), as per Prostate Cancer Clinical Trials Working Group [PCWG3] criteria.

Evaluar la eficacia de pamiparib en pacientes con cáncer de próstata metastásico resistente a la castración (CPRCm) positivo para células tumorales circulantes (CTC) con deficiencia de recombinación homóloga (positivo para CTC-DRH; según el ensayo de Epic Sciences), conforme a los criterios del grupo de trabajo de ensayos clínicos de cáncer de prostate [PCWG3].

E.2.2

Secondary objectives of the trial

- To further evaluate the efficacy of pamiparib in patients with CTC-HRD-positive mCRPC with measurable disease (Cohort 1 of Synopsis Table 1), as per PCWG3 criteria;
- To further evaluate the efficacy of pamiparib in patients with CTC-HRD-positive mCRPC with or without measurable disease (Cohorts 1 and 2 of Synopsis Table 1, respectively), as per PCWG3 criteria;
- To evaluate the safety and tolerability of pamiparib.

-Evaluar más a fondo la eficacia de pamiparib en pacientes con CPRCm positivo para CTC-DRH con enfermedad medible (cohorte 1 de la sinopsis, tabla 1), según los criterios del PCWG3.
-Evaluar más a fondo la eficacia de pamiparib en pacientes con CPRCm positivo para CTC-DRH con o sin enfermedad medible (cohortes 1 y 2 de la sinopsis, tabla 1, respectivamente), según los criterios del PCWG3.
-Evaluar la seguridad y tolerabilidad de pamiparib

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

- The population under study is men (> 18 years of age) with histologically or cytologically confirmed adenocarcinoma or poorly differentiated adenocarcinoma of the prostate without neuroendocrine differentiation with HRD deficiency by CTC-HRD assay and/or deleterious germline or somatic mutation in BRCA1 or BRCA2; mCRPC measurable disease and/or bone disease. Patients must have PSA progression with > 3 rising PSA levels with > 1 week between determinations and a screening PSA > 2 μg/L (2 ng/mL). Patients must be surgically or medically castrated with serum testosterone levels of < 1.73 nmol/L (50 ng/dL), must have received > 1 prior androgen receptor-targeted therapy, and must have received > 1 taxane-based therapy.
- mCRPC with 1 or 2 of the following:
- Measurable disease per RECIST v1.1
- Bone disease
- CTC-HRD+ or BRCA1/2 mutation
- PSA progression (PCWG3 criteria)
- ≥1 androgen receptor-targeted therapy (eg, abiraterone acetate/prednisone or enzalutamide) for mCRPC with progressive disease
- ≥1 taxane for metastatic prostate cancer
- Prior sipuleucel-T and checkpoint inhibitors

-La población objeto de estudio son pacientes varones (≥18 años) con adenocarcinoma confirmado mediante histología o citología,o adenocarcinoma pobremente diferenciado de la próstata sin diferenciación neuroendocrina con deficiencia de RH según el ensayo CTC-DRH y/o la mutación de línea germinal o somática deletéreas en BRCA1 o BRCA2; CPRCm medible y/o enfermedad ósea.
Los pacientes deben presentar progresión del PSA con ≥3 niveles de PSA en aumento con ≥1 semana entre determinaciones y una selección del PSA ≥2 μg/l (2 ng/ml). Los pacientes deben haberse
sometido a castración médica o quirúrgica con niveles séricos de testosterona ≤1,73 nmol/l (50 ng/dl), y deben haber recibido ≥1 tratamiento previo para receptores androgénicos y ≥1 tratamiento con
taxanos.
-CPRCm con 1 o 2 de los siguientes:
Enfermedad medible por RECIST v1.1
Enfermedad ósea
CTC-DRH+ o mutación de BRCA1/2
Progresión del PSA según los criterios de PCWG3
≥1 tratamiento para receptores androgénicos (p. ej. acetato de abiraterona/prednisone o enzalutamida) para CPRCm con EP
≥1 tratamiento con taxanos para el cáncer de próstata metastásico
Sipuleucel-T e inhibidores de puntos de control anteriores

E.4

Principal exclusion criteria

- Chemotherapy, hormonal therapy, biologic therapy, radionuclide therapy, immunotherapy, investigational agent, anticancer Chinese medicine, or herbal remedies ≤ 5 half-lives if the half-life is known, ≤ 14 days if not known, before start of study treatment.
- Continued treatment with a bisphosphonate or denosumab is allowed, if administered at a stable dose > 28 days before start of study treatment.
- Radiotherapy ≤ 21 days (≤ 14 days, if single fraction of radiotherapy) before start of study treatment.
- Prior treatment for prostate cancer with any of the following:
- PARP inhibitor
- Platinum
- Cyclophosphamide
- Mitoxantrone

-Quimioterapia, tratamiento hormonal, tratamiento biológico, uso terapéutico de radionúclidos, inmunoterapia, agentes en investigación, medicina china contra el cáncer o remedios con plantas medicinales
≤5 semividas si se conoce la semivida y ≤14 días si no se conoce, antes del inicio del tratamiento del estudio.
-Se permite el tratamiento continuado con un bifosfonato o denosumab, si se administra en una dosis estable> 28 días antes del inicio del tratamiento del estudio.
- Radioterapia ≤ 21 días (≤ 14 días, si es una fracción única de la radioterapia) antes del inicio del tratamiento del estudio.
- Tratamiento previo para el cáncer de próstata con cualquiera de los siguientes:
- inhibidor de PARP
- platino
- Ciclofosfamida
- Mitoxantrona

E.5 End points

E.5.1

Primary end point(s)

1. Objective Response Rate determined by independent central review [Time Frame: through study completion, an average of 1 year]
2. Prostate-Specific Antigen (PSA) response rate [Time Frame: through study completion, an average of 1 year]

1. Tasa de respuesta objetiva determinada por una revisión central independiente [Marco de tiempo: hasta la finalización del estudio, un promedio de 1 año]
2. Tasa de respuesta del antígeno prostático específico (APE) [Marco de tiempo: hasta la finalización del estudio, un promedio de 1 año]

E.5.1.1

Timepoint(s) of evaluation of this end point

Through study completion, an average of 1 year; 24 months since the first patient enrolled

Hasta la finalización del estudio, un promedio de 1 año; 24 meses desde que se incluye el primer paciente.

E.5.2

Secondary end point(s)

1. Duration of response [Time Frame: through study completion, an average of 1 year]
2. Objective Response Rate by Investigator [Time Frame: through study completion, an average of 1 year]
3. Time to Objective Response [Time Frame: through study completion, an average of 1 year]

1. Duración de la respuesta [Marco de tiempo: hasta la finalización del estudio, un promedio de 1 año]
2. Tasa de respuesta objetiva por investigador [Marco de tiempo: hasta la finalización del estudio, un promedio de 1 año]
3. Tiempo para la respuesta objetiva [Marco de tiempo: hasta la finalización del estudio, un promedio de 1 año]

E.5.2.1

Timepoint(s) of evaluation of this end point

Through study completion, an average of 1 year; 24 months since the first patient enrolled

Hasta la finalización del estudio, un promedio de 1 año; 24 meses desde que se incluye el primer paciente.

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

Yes

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

Yes

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

E.8.1.1

Randomised

E.8.1.2

Open

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

E.8.2.3

Other

E.8.3

The trial involves single site in the Member State concerned

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

E.8.5

The trial involves multiple Member States

Yes

E.8.5.1

Number of sites anticipated in the EEA

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

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

France

Germany

Spain

United Kingdom

United States

E.8.7

Trial has a data monitoring committee

Yes

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

The end of study is defined as the last patient last visit at the end of the long-term follow-up phase. This is the last timepoint for data collection. A patient is considered on study as long as the patient is still in long-term follow-up.

El final del estudio se define como la última visita del último paciente al final de la fase de seguimiento a largo plazo. Este es el último punto para la recopilación de datos. Se considera que un paciente está en estudio siempre y cuando el paciente aún esté en un seguimiento a largo plazo.

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial years

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

F.2 Gender

F.2.1

Female

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.4.2

For a multinational trial

F.4.2.1

In the EEA

F.4.2.2

In the whole clinical trial

100

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

None

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2019-06-05

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2019-05-28

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2020-09-02

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