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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03712930




Registration number
NCT03712930
Ethics application status
Date submitted
11/10/2018
Date registered
19/10/2018
Date last updated
19/07/2019

Titles & IDs
Public title
Treatment of Patients With 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
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 60 mg PO BID

Experimental: Approximately 100 subjects to receive pamiparib orally. -


Treatment: Drugs: Pamiparib 60 mg PO BID
Pamiparib 60 mg PO BID

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Objective Response Rate determined by independent central review
Timepoint [1] 0 0
through study completion, an average of 1 year
Primary outcome [2] 0 0
Prostate-Specific Antigen (PSA) response rate
Timepoint [2] 0 0
through study completion, an average of 1 year
Secondary outcome [1] 0 0
Duration of response
Timepoint [1] 0 0
through study completion, an average of 1 year
Secondary outcome [2] 0 0
Objective Response Rate by Investigator
Timepoint [2] 0 0
through study completion, an average of 1 year
Secondary outcome [3] 0 0
Time to Objective Response
Timepoint [3] 0 0
through study completion, an average of 1 year

Eligibility
Key inclusion criteria
- 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

- Prior sipuleucel-T and checkpoint inhibitors"
Minimum age
18 Years
Maximum age
No limit
Gender
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:

- PARP inhibitor

- Platinum

- Cyclophosphamide

- Mitoxantrone"

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)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Gosford Hospital - Gosford
Recruitment hospital [2] 0 0
Calvary Mater Newcastle - Waratah
Recruitment hospital [3] 0 0
Icon Cancer Care Foundation - South Brisbane
Recruitment hospital [4] 0 0
The Alfred Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
2250 - Gosford
Recruitment postcode(s) [2] 0 0
2298 - Waratah
Recruitment postcode(s) [3] 0 0
044101 - South Brisbane
Recruitment postcode(s) [4] 0 0
3004 - Melbourne
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
Texas
Country [3] 0 0
Puerto Rico
State/province [3] 0 0
Rio Piedras

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

Ethics approval
Ethics application status

Summary
Brief summary
This study is designed to evaluate the efficacy of pamiparib in patients with metastatic
castration-resistant prostate cancer (mCRPC) positive for circulating tumor cells (CTC) with
homologous recombination deficiency (CTC-HRD). All patients 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
Trial website
https://clinicaltrials.gov/show/NCT03712930
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Cristina Seltzer
Address 0 0
Country 0 0
Phone 0 0
1 (877) 828-5568
Fax 0 0
Email 0 0
clinicaltrials@beigene.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT03712930