Clinical trial • Phase II • Oncology

niraparib; abiraterone acetate for Metastatic castration-resistant prostate cancer

Phase II trial of niraparib; abiraterone acetate for Metastatic castration-resistant prostate cancer.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Metastatic castration-resistant prostate cancer
Trial Stage
Phase II
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
28-03-2024
First CTIS Authorization Date
06-05-2024

Trial design

Niraparib and abiraterone acetate co-administered as single agents (dose and schedule not specified in record)-controlled Phase II trial across 4 sites in Netherlands, Poland, Spain.

Comparator
Niraparib and abiraterone acetate co-administered as single agents (dose and schedule not specified in record)
Single Multiple Or Escalation Dose Combined
Yes
Target Sample Size
100

Eligibility

Recruits 100 No vulnerable population selected; only adult male participants (male only). Consent details not provided in the record..

Vulnerable Population
No vulnerable population selected; only adult male participants (male only). Consent details not provided in the record.

Recruitment

Planned Sample Size
100
Recruitment Window Months
59

Geography

Total Number Of Sites
4
Total Number Of Participants
41

Netherlands

Earliest CTIS Part Ii Submission Date
19-04-2024
Latest Decision Or Authorization Date
11-11-2025
Processing Time Days
571
Number Of Sites
1
Number Of Participants
11

Sites

Site Name
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Department Name
medical oncology
Contact Person Name
Henk Verheul
Contact Person Email
h.verheul@erasmusmc.nl

Poland

Earliest CTIS Part Ii Submission Date
19-04-2024
Latest Decision Or Authorization Date
13-11-2025
Processing Time Days
573
Number Of Sites
2
Number Of Participants
19

Sites

Site Name
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Department Name
Oddział Badań Wczesnych Faz
Contact Person Name
Iwona Ługowska
Contact Person Email
iwona.lugowska@pib-nio.pl
Site Name
Uniwersyteckie Centrum Kliniczne
Department Name
Ośrodek Badań Klinicznych Wczesnych Faz
Contact Person Name
Rafał Dziadziuszko
Contact Person Email
rafald@gumed.edu.pl

Spain

Earliest CTIS Part Ii Submission Date
19-04-2024
Latest Decision Or Authorization Date
17-11-2025
Processing Time Days
577
Number Of Sites
1
Number Of Participants
11

Sites

Site Name
Hospital Universitario Virgen De La Victoria
Department Name
MEDICAL ONCOLOGY DEPARTMENT. PHASE I CLINICAL TRIALS UNIT
Contact Person Name
Laura Medina Rodríguez
Contact Person Email
laura.medina@ibima.eu

Sponsor

Primary sponsor

Full Name
Janssen Cilag International
Organisation Type
Pharmaceutical company
Country Of Registered Address
Belgium

Investigational products

Investigational Product Name
Fixed-dose combination tablet of niraparib plus abiraterone acetate (low-strength and regular-strength formulations)
Active Substance
niraparib; abiraterone acetate
Modality
Small molecule
Routes Of Administration
oral (tablet)
Route
oral
Investigational Product Name
Niraparib (single agent)
Active Substance
niraparib
Modality
Small molecule
Routes Of Administration
oral (tablet)
Route
oral
Investigational Product Name
Abiraterone acetate (single agent)
Active Substance
abiraterone acetate
Modality
Small molecule
Routes Of Administration
oral (tablet)
Route
oral
Combination Treatment
Yes

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