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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
Date last updated
17/11/2021

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
Timepoint [1] 0 0
Up to 1 year and 6 months
Primary outcome [2] 0 0
Prostate-Specific Antigen (PSA) Response Rate
Timepoint [2] 0 0
Up to 1 year and 6 months
Secondary outcome [1] 0 0
Duration of Response (DOR) by IRC
Timepoint [1] 0 0
Up to 1 year and 7 months
Secondary outcome [2] 0 0
Objective Response Rate by Investigator
Timepoint [2] 0 0
Up to 1 year and 6 months
Secondary outcome [3] 0 0
Time to Objective Response by Investigator
Timepoint [3] 0 0
Up to 1 year and 6 months
Secondary outcome [4] 0 0
Clinical Benefit Rate By Investigator
Timepoint [4] 0 0
Up to 1 year and 6 months
Secondary outcome [5] 0 0
Time to PSA Response
Timepoint [5] 0 0
Up to 1 year and 6 months
Secondary outcome [6] 0 0
Duration of PSA Response
Timepoint [6] 0 0
Up to 1 year and 7 months
Secondary outcome [7] 0 0
Time to PSA Progression
Timepoint [7] 0 0
Up to 1 year and 7 months
Secondary outcome [8] 0 0
Time to Symptomatic Skeletal Event
Timepoint [8] 0 0
Up to 1 year and 7 months
Secondary outcome [9] 0 0
Radiographic Progression-Free Survival by IRC
Timepoint [9] 0 0
Up to 1 year and 7 months
Secondary outcome [10] 0 0
Overall Survival (OS)
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
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
Address
Country

Ethics approval
Ethics application status

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
Trial website
https://clinicaltrials.gov/study/NCT03712930
Trial related presentations / publications
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
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



Summary Results

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