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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT02854436
Ethics application status
Date submitted
1/08/2016
Date registered
3/08/2016
Date last updated
2/12/2019

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
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders
Reproductive Health and Childbirth 0 0 0 0
Fetal medicine and complications of pregnancy

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) - ORR of soft tissue disease with no evidence of bone progression in participants with in Breast Cancer gene 1 (BRCA1) or gene 2 (BRCA2). ORR is defined as proportion of participants with best objective response of complete response (CR) or partial response (PR) based on Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST v1.1) criteria.
Timepoint [1] 0 0
Screening, Cycle 1 (each cycle of 28 days) Day 1 (every 8 weeks for the first 6 months and then every 12 weeks thereafter) till Follow-up Phase
Secondary outcome [1] 0 0
Objective Response Rate (ORR) - ORR in participants with measurable metastatic castration-resistant prostate cancer (mCRPC) and DNA-repair anomalies. ORR of soft tissue (visceral or nodal disease) as defined by RECIST 1.1 with no evidence of bone progression according to the Prostate Cancer Working Group 3 (PCWG3) criteria.
Timepoint [1] 0 0
Up to 4 years and 6 months
Secondary outcome [2] 0 0
Circulating Tumor Cells (CTC) Response - CTC response defined as CTC=0 per 7.5 milliliter (mL) blood at 8 weeks post-baseline in participants with baseline CTC greater than (>) 0.
Timepoint [2] 0 0
From Screening till End of Treatment (30 {+/- 5} days of last dose -up to 4 years and 6 months)
Secondary outcome [3] 0 0
Overall Survival (OS) - OS is defined as time from enrollment to death from any cause.
Timepoint [3] 0 0
From enrollment to completion of study (up to 4 years and 6 months)
Secondary outcome [4] 0 0
Radiographic Progression-Free Survival (rPFS) - rPFS is defined as time from enrollment to radiographic progression or death.
Timepoint [4] 0 0
From enrollment to completion of study (up to 4 years and 6 months)
Secondary outcome [5] 0 0
Time to Prostate Specific Antigen (PSA) Progression - First PSA increase that is 25 percent (%) or greater and an absolute increase of 2 nanogram/milliliter (ng/mL) or more above the nadir.
Timepoint [5] 0 0
From enrollment to completion of study (up to 4 years and 6 months)
Secondary outcome [6] 0 0
Time to Symptomatic Skeletal Event (SSE) - Time to SSE: time from enrollment to first symptomatic fracture, radiation or surgery to bone, or spinal cord compression.
Timepoint [6] 0 0
From enrollment to completion of study (up to 4 years and 6 months)
Secondary outcome [7] 0 0
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Timepoint [7] 0 0
From enrollment to completion of study (up to 4 years and 6 months)
Secondary outcome [8] 0 0
Duration of Objective Response - Duration of objective response is defined as time from complete response or partial response to radiographic progression of disease, unequivocal clinical progression or death, whichever occurs first.
Timepoint [8] 0 0
From complete response (CR) or partial response (PR) to radiographic progression of disease (up to 4 years 6 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
Gender
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
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
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Chris O'Brien Lifehouse - Camperdown
Recruitment hospital [2] 0 0
St. Vincent's Hospital Sydney - Darlinghurst
Recruitment hospital [3] 0 0
Border Medical Oncology - East Albury
Recruitment hospital [4] 0 0
Ashford Cancer Centre - Kurralta Park
Recruitment hospital [5] 0 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment hospital [6] 0 0
Fiona Stanley Hospital - Murdoch
Recruitment hospital [7] 0 0
Macquarie University Hospital - North Ryde
Recruitment hospital [8] 0 0
Port Macquarie Base Hospital - Port Macquarie
Recruitment hospital [9] 0 0
Prince Of Wales Hospital - Randwick
Recruitment hospital [10] 0 0
Sydney Adventist Hospital - Wahroonga
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [3] 0 0
2640 - East Albury
Recruitment postcode(s) [4] 0 0
5037 - Kurralta Park
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3000 - Melbourne
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6150 - Murdoch
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2109 - North Ryde
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2444 - Port Macquarie
Recruitment postcode(s) [9] 0 0
2031 - Randwick
Recruitment postcode(s) [10] 0 0
2076 - Wahroonga
Recruitment outside Australia
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Charleroi
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Taunton

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/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
Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions:
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
JNJ.CT@sylogent.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT02854436