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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT02854436




Registration number
NCT02854436
Ethics application status
Date submitted
1/08/2016
Date registered
3/08/2016
Date last updated
13/11/2023

Titles & IDs
Public title
An Efficacy and Safety Study of Niraparib in Men With Metastatic Castration-Resistant Prostate Cancer and DNA-Repair Anomalies
Scientific title
A Phase 2 Efficacy and Safety Study of Niraparib in Men With Metastatic Castration-Resistant Prostate Cancer and DNA-Repair Anomalies
Secondary ID [1] 0 0
64091742PCR2001
Secondary ID [2] 0 0
CR108208
Universal Trial Number (UTN)
Trial acronym
Galahad
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prostatic Neoplasms 0 0
Condition category
Condition code
Cancer 0 0 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Niraparib

Experimental: Niraparib - Participants will receive 300 milligram (mg) niraparib (3 capsules*100 mg) orally once daily.


Treatment: Drugs: Niraparib
Participants will receive 300 mg niraparib (3 capsules*100 mg) orally once daily.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Objective Response Rate (ORR) for Participants With Measurable Metastatic Castration-resistant Prostate Cancer (mCRPC) and Breast Cancer Gene (BRCA) Mutation
Timepoint [1] 0 0
Up to 52 months
Secondary outcome [1] 0 0
Objective Response Rate for Participants With Measurable Metastatic Castration-resistant Prostate Cancer (mCRPC) and Non-Breast Cancer Gene (BRCA) Mutation
Timepoint [1] 0 0
Up to 52 months
Secondary outcome [2] 0 0
Circulating Tumor Cells (CTC) Response Rate
Timepoint [2] 0 0
At 8 weeks post-baseline
Secondary outcome [3] 0 0
Overall Survival (OS)
Timepoint [3] 0 0
Up to 52 months
Secondary outcome [4] 0 0
Radiographic Progression-Free Survival (rPFS)
Timepoint [4] 0 0
Up to 52 months
Secondary outcome [5] 0 0
Time to Radiographic Progression
Timepoint [5] 0 0
Up to 52 months
Secondary outcome [6] 0 0
Time to Prostate-Specific Antigen (PSA) Progression
Timepoint [6] 0 0
Up to 52 months
Secondary outcome [7] 0 0
Time to Symptomatic Skeletal Event (SSE)
Timepoint [7] 0 0
Up to 52 months
Secondary outcome [8] 0 0
Duration of Objective Response
Timepoint [8] 0 0
Up to 52 months
Secondary outcome [9] 0 0
Number of Participants With Adverse Events (AEs)
Timepoint [9] 0 0
Up to 52 months
Secondary outcome [10] 0 0
Number of Participants With Worst Toxicity Grades for Clinical Laboratory Tests Based on National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE)
Timepoint [10] 0 0
Up to 52 months

Eligibility
Key inclusion criteria
- Histologically confirmed prostate cancer (mixed histology is acceptable, with the
exception of the small cell pure phenotype, which is excluded)

- Received a taxane-based chemotherapy for the treatment of metastatic prostate cancer
with evidence of disease progression on or after treatment, or discontinued from a
taxane-based chemotherapy due to an adverse event

- Received a second-generation or later androgen receptor (AR)-targeted therapy (for
example, abiraterone acetate plus prednisone, enzalutamide, apalutamide) for the
treatment of metastatic prostate cancer with evidence of disease progression or
non-metastatic castration-resistant prostate cancer with evidence of subsequent
metastasis

- Biomarker-positive by at least one of the following criteria: (a) Biallelic
deoxyribonucleic acid (DNA)-repair anomaly based on a sponsor validated blood or
tissue assay; (b) Germline pathogenic Breast Cancer gene (BRCA) 1 or BRCA2 by any test
(somatic local results must be confirmed as positive by the sponsor-validated assay
before dosing)

- Progression of metastatic prostate cancer in the setting of castrate levels of
testosterone or history of bilateral orchiectomy at study entry
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
- Prior treatment with a poly (adenosine diphosphate [ADP] ribose) polymerase (PARP)
inhibitor

- Prior platinum-based chemotherapy for the treatment of prostate cancer

- Known history or current diagnosis of myelodysplastic syndrome (MDS)/acute myeloid
leukemia (AML)

- Symptomatic or impending cord compression

- Symptomatic brain metastases

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
31/08/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
16/08/2023
Sample size
Target
Accrual to date
Final
289
Recruitment in Australia
Recruitment state(s)
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- Camperdown
Recruitment hospital [2] 0 0
- Darlinghurst
Recruitment hospital [3] 0 0
- East Albury
Recruitment hospital [4] 0 0
- Kurralta Park
Recruitment hospital [5] 0 0
- Macquarie University
Recruitment hospital [6] 0 0
- Melbourne
Recruitment hospital [7] 0 0
- Murdoch
Recruitment hospital [8] 0 0
- Port Macquarie
Recruitment hospital [9] 0 0
- Randwick
Recruitment hospital [10] 0 0
- Wahroonga
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- Camperdown
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- Darlinghurst
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- East Albury
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- Kurralta Park
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- Macquarie University
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- Melbourne
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- Murdoch
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- Port Macquarie
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- Randwick
Recruitment postcode(s) [10] 0 0
- Wahroonga
Recruitment outside Australia
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Arizona
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Charleroi
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Gent
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Hasselt
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Preston

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Janssen Research & Development, LLC
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to assess the efficacy, safety, and pharmacokinetics of
niraparib in men with metastatic castration-resistant prostate cancer (mCRPC) and
deoxyribonucleic acid (DNA) repair anomalies.
Trial website
https://clinicaltrials.gov/ct2/show/NCT02854436
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Janssen Research & Development, LLC Clinical Trial
Address 0 0
Janssen Research & Development, LLC
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries