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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT03712930
Registration number
NCT03712930
Ethics application status
Date submitted
11/10/2018
Date registered
19/10/2018
Titles & IDs
Public title
Treatment of Metastatic Castration-Resistant Prostate Cancer With Homologous Recombination Deficiency
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Scientific title
A Phase 2, Open-Label, Single-Arm Study of BGB-290 (BGB-290) for the Treatment of Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC) With Homologous Recombination Deficiency (HRD)
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Secondary ID [1]
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2018-002587-28
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Secondary ID [2]
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BGB-290-202
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Metastatic Castration-Resistant Prostate Cancer (mCRPC)
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Homologous Recombination Deficiency (HRD)
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Condition category
Condition code
Cancer
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Prostate
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Pamiparib
Experimental: Pamiparib - Participants will receive pamiparib for a period up to 1 year
Treatment: Drugs: Pamiparib
60 mg orally twice daily (BID)
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Objective Response Rate (ORR) Determined by Independent Review Committee
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Assessment method [1]
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ORR is the percentage of participants with a best objective response of complete response (CR) or partial response (PR) confirmed at a subsequent timepoint = 4 weeks later by an Independent Review Committee (IRC).
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Timepoint [1]
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Up to 1 year and 6 months
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Primary outcome [2]
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Prostate-Specific Antigen (PSA) Response Rate
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Assessment method [2]
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PSA response rate is defined as the percentage of participants with PSA decline = 50% from baseline \[confirmed by a second PSA value = 3 weeks later\] for CTC-HRD-positive participants with or without measurable disease.
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Timepoint [2]
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Up to 1 year and 6 months
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Secondary outcome [1]
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Duration of Response (DOR) by IRC
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Assessment method [1]
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DOR is defined as the time from the date of the earliest documented CR or PR (that is subsequently confirmed) to radiographic disease progression or death due to any cause, whichever occurs first.
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Timepoint [1]
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Up to 1 year and 7 months
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Secondary outcome [2]
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Objective Response Rate by Investigator
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Assessment method [2]
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ORR is the percentage of participants with a best objective response of complete response (CR) or partial response (PR) confirmed at a subsequent timepoint = 4 weeks later by the investigator.
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Timepoint [2]
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Up to 1 year and 6 months
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Secondary outcome [3]
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Time to Objective Response by Investigator
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Assessment method [3]
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Time to objective response is defined as the time from the date of the first dose of study drug to the first documented confirmed response of CR or PR assessed by the investigator and summarized for participants who have achieved a confirmed objective response.
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Timepoint [3]
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Up to 1 year and 6 months
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Secondary outcome [4]
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Clinical Benefit Rate By Investigator
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Assessment method [4]
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Clinical Benefit Rate is the percentage of participants who achieved confirmed CR, PR, or SD or NON-CR/NON-PD. The minimum interval for confirmed CR and PR is 4 weeks and the measurement of SD or NON-CR/NON-PD is 7 weeks after first dose date.
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Timepoint [4]
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Up to 1 year and 6 months
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Secondary outcome [5]
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Time to PSA Response
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Assessment method [5]
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Time to PSA response is defined as the time from the date of the first dose of study drug to the first PSA decline = 50% that is subsequently confirmed. Assessments are summarized for participants who have achieved a confirmed PSA response.
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Timepoint [5]
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Up to 1 year and 6 months
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Secondary outcome [6]
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Duration of PSA Response
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Assessment method [6]
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Duration of PSA response is defined as the time from the date of the earliest documented PSA response (that is subsequently confirmed) to PSA progression or death due to any cause, whichever occurs first. PSA progression is defined as a = 25% increase in PSA with an absolute increase of = 2 µg/L above the nadir (or above the baseline for participants with no PSA decline) after12 weeks, confirmed by a second value = 3 weeks later. The nadir is defined as the lowest value at or after baseline.
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Timepoint [6]
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Up to 1 year and 7 months
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Secondary outcome [7]
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Time to PSA Progression
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Assessment method [7]
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Time to PSA progression is defined as the time from the date of the first dose of study drug to a = 25% increase in PSA with an absolute increase of = 2 ng/mL above the nadir (or above the baseline for participants with no PSA decline) after 12 weeks, confirmed by a second value = 3 weeks later. Death for the participants with no PSA progression is also considered as an event.
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Timepoint [7]
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Up to 1 year and 7 months
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Secondary outcome [8]
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Time to Symptomatic Skeletal Event
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Assessment method [8]
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Time to symptomatic skeletal event (SSE) is defined as time from the date of the first dose of study drug to the first symptomatic fracture, radiation or surgery to bone, or spinal cord compression.
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Timepoint [8]
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Up to 1 year and 7 months
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Secondary outcome [9]
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Radiographic Progression-Free Survival by IRC
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Assessment method [9]
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Radiographic progression-free survival is defined as the time from the date of the first dose of study drug to radiographic disease progression by IRC or death due to any cause, whichever occurs first.
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Timepoint [9]
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Up to 1 year and 7 months
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Secondary outcome [10]
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Overall Survival (OS)
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Assessment method [10]
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Overall survival is defined as the time from the date of the first dose of study drug to death due to any cause.
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Timepoint [10]
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Up to 1 year and 7 months
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Secondary outcome [11]
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Number of Participants With Treatment-Emergent Adverse Events Graded According to National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 4.03
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Assessment method [11]
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Timepoint [11]
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From the date of first Pamiparib dose until 30 days after the last dose or initiation of new anti-cancer therapy, whichever occurs first. (Up to 1 year and 7 months)
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Eligibility
Key inclusion criteria
Key
* 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. • PSA progression with = 3 rising PSA levels with = 1 week between determinations and a screening PSA = 2 µg/L (2 ng/mL).
* 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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Males
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Can healthy volunteers participate?
No
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Key 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:
* poly ADP ribose polymerase (PARP) inhibitor
* Platinum
* Cyclophosphamide
* Mitoxantrone
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
NA
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Stopped early
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
5/02/2019
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
2/09/2020
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Sample size
Target
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Accrual to date
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Final
13
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Recruitment in Australia
Recruitment state(s)
NSW,QLD
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Recruitment hospital [1]
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Gosford Hospital - Gosford
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Recruitment hospital [2]
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Liverpool Hospital - Liverpool
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Recruitment hospital [3]
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Calvary Mater Newcastle - Waratah
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Recruitment hospital [4]
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Icon Cancer Care Foundation - South Brisbane
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Recruitment postcode(s) [1]
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2250 - Gosford
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Recruitment postcode(s) [2]
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2170 - Liverpool
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Recruitment postcode(s) [3]
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2298 - Waratah
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Recruitment postcode(s) [4]
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044101 - South Brisbane
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Georgia
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Country [2]
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United States of America
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State/province [2]
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New York
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Country [3]
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United States of America
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State/province [3]
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Washington
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Country [4]
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Puerto Rico
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State/province [4]
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Rio Piedras
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Country [5]
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Spain
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State/province [5]
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Barcelona
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
BeiGene
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
This study is designed to evaluate the efficacy of pamiparib in participants with metastatic castration-resistant prostate cancer (mCRPC) positive for circulating tumor cells (CTC) with homologous recombination deficiency (CTC-HRD). All participants will receive pamiparib. The purpose of this study is to demonstrate that pamiparib will improve Objective Response Rate (ORR) and Prostate-Specific Antigen (PSA) response rate
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Trial website
https://clinicaltrials.gov/study/NCT03712930
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Study Director
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Address
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Guy's and St Thomas' NHS Foundation Trust
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
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When will data be available (start and end dates)?
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Available to whom?
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Available for what types of analyses?
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How or where can data be obtained?
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What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/30/NCT03712930/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/30/NCT03712930/SAP_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT03712930