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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
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)
Secondary ID [1] 0 0
2018-002587-28
Secondary ID [2] 0 0
BGB-290-202
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metastatic Castration-Resistant Prostate Cancer (mCRPC) 0 0
Homologous Recombination Deficiency (HRD) 0 0
Condition category
Condition code
Cancer 0 0 0 0
Prostate

Intervention/exposure
Study type
Interventional
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)
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Objective Response Rate (ORR) Determined by Independent Review Committee
Assessment method [1] 0 0
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).
Timepoint [1] 0 0
Up to 1 year and 6 months
Primary outcome [2] 0 0
Prostate-Specific Antigen (PSA) Response Rate
Assessment method [2] 0 0
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.
Timepoint [2] 0 0
Up to 1 year and 6 months
Secondary outcome [1] 0 0
Duration of Response (DOR) by IRC
Assessment method [1] 0 0
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.
Timepoint [1] 0 0
Up to 1 year and 7 months
Secondary outcome [2] 0 0
Objective Response Rate by Investigator
Assessment method [2] 0 0
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.
Timepoint [2] 0 0
Up to 1 year and 6 months
Secondary outcome [3] 0 0
Time to Objective Response by Investigator
Assessment method [3] 0 0
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.
Timepoint [3] 0 0
Up to 1 year and 6 months
Secondary outcome [4] 0 0
Clinical Benefit Rate By Investigator
Assessment method [4] 0 0
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.
Timepoint [4] 0 0
Up to 1 year and 6 months
Secondary outcome [5] 0 0
Time to PSA Response
Assessment method [5] 0 0
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.
Timepoint [5] 0 0
Up to 1 year and 6 months
Secondary outcome [6] 0 0
Duration of PSA Response
Assessment method [6] 0 0
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.
Timepoint [6] 0 0
Up to 1 year and 7 months
Secondary outcome [7] 0 0
Time to PSA Progression
Assessment method [7] 0 0
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.
Timepoint [7] 0 0
Up to 1 year and 7 months
Secondary outcome [8] 0 0
Time to Symptomatic Skeletal Event
Assessment method [8] 0 0
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.
Timepoint [8] 0 0
Up to 1 year and 7 months
Secondary outcome [9] 0 0
Radiographic Progression-Free Survival by IRC
Assessment method [9] 0 0
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.
Timepoint [9] 0 0
Up to 1 year and 7 months
Secondary outcome [10] 0 0
Overall Survival (OS)
Assessment method [10] 0 0
Overall survival is defined as the time from the date of the first dose of study drug to death due to any cause.
Timepoint [10] 0 0
Up to 1 year and 7 months
Secondary outcome [11] 0 0
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
Assessment method [11] 0 0
Timepoint [11] 0 0
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)

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

Key
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
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
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
5/02/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
2/09/2020
Sample size
Target
Accrual to date
Final
13
Recruitment in Australia
Recruitment state(s)
NSW,QLD
Recruitment hospital [1] 0 0
Gosford Hospital - Gosford
Recruitment hospital [2] 0 0
Liverpool Hospital - Liverpool
Recruitment hospital [3] 0 0
Calvary Mater Newcastle - Waratah
Recruitment hospital [4] 0 0
Icon Cancer Care Foundation - South Brisbane
Recruitment postcode(s) [1] 0 0
2250 - Gosford
Recruitment postcode(s) [2] 0 0
2170 - Liverpool
Recruitment postcode(s) [3] 0 0
2298 - Waratah
Recruitment postcode(s) [4] 0 0
044101 - South Brisbane
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Georgia
Country [2] 0 0
United States of America
State/province [2] 0 0
New York
Country [3] 0 0
United States of America
State/province [3] 0 0
Washington
Country [4] 0 0
Puerto Rico
State/province [4] 0 0
Rio Piedras
Country [5] 0 0
Spain
State/province [5] 0 0
Barcelona

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
BeiGene
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Public notes

Contacts
Principal investigator
Name 0 0
Study Director
Address 0 0
Guy's and St Thomas' NHS Foundation Trust
Country 0 0
Phone 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

TypeOther DetailsAttachment
Study protocol
Statistical analysis plan



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT03712930