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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03427814




Registration number
NCT03427814
Ethics application status
Date submitted
5/02/2018
Date registered
9/02/2018

Titles & IDs
Public title
Study of BGB-290 or Placebo in Participants With Advanced or Inoperable Gastric Cancer
Scientific title
A Phase 2, Double-blind, Randomized Study of BGB-290 Versus Placebo as Maintenance Therapy in Patients With Inoperable Locally Advanced or Metastatic Gastric Cancer That Responded to Platinum-based First-line Chemotherapy
Secondary ID [1] 0 0
2017-003493-13
Secondary ID [2] 0 0
BGB-290-303
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced or Inoperable Gastric Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Stomach

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Pamiparib
Treatment: Drugs - Placebo

Experimental: Pamiparib - Participants received pamiparib orally.

Placebo comparator: Placebo - Participants received placebo orally.


Treatment: Drugs: Pamiparib
60 mg orally twice daily

Treatment: Drugs: Placebo
60 mg orally twice daily
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression Free Survival (PFS) by Investigator Assessment
Timepoint [1] 0 0
Approximately 23 months
Secondary outcome [1] 0 0
Overall Survival (OS)
Timepoint [1] 0 0
Approximately 23 months
Secondary outcome [2] 0 0
Time To Second Subsequent Treatment (TSST)
Timepoint [2] 0 0
Approximately 23 months
Secondary outcome [3] 0 0
Objective Response Rate (ORR)
Timepoint [3] 0 0
Approximately 23 months
Secondary outcome [4] 0 0
Duration of Response (DOR)
Timepoint [4] 0 0
Approximately 23 months
Secondary outcome [5] 0 0
Time To Response
Timepoint [5] 0 0
Approximately 23 months
Secondary outcome [6] 0 0
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Timepoint [6] 0 0
From start of study treatment until 30 days after the last study drug intake or initiation of new anticancer therapy, whichever occurs first (up to approximately 4 years and 5.5 months)

Eligibility
Key inclusion criteria
Key

1. Age = 18 years.
2. Signed informed consent.
3. Histologically confirmed inoperable locally advanced or metastatic adenocarcinoma of the stomach or gastroesophageal junction.
4. Received platinum based first line chemotherapy for = 28 weeks.
5. Confirmed partial response (PR) maintained for = 4 weeks or complete response (CR).
6. Able to be randomized to study = 8 weeks after last platinum dose.
7. Eastern Cooperative Oncology Group (ECOG) performance status = 1.
8. Adequate hematologic, renal and hepatic function.
9. Must be able to provide archival tumor tissue for central biomarker assessment.
10. Females of childbearing potential and non-sterile males must agree to use highly effective methods of birth control throughout the course of study and at least up to 6 months after last dosing.

Key
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Unresolved acute effects of prior therapy = Grade 2.
2. Prior treatment with PARP inhibitor.
3. Chemotherapy, biologic therapy, immunotherapy or other anticancer therapy = 14 days prior to randomization.
4. Major surgery or significant injury = 2 weeks prior to start of study treatment.
5. Diagnosis of myelodysplastic syndrome (MDS)
6. Other diagnoses of significant malignancy
7. Leptomeningeal disease or brain metastasis
8. Inability to swallow capsules or disease affecting gastrointestinal function.
9. Active infections requiring systemic treatment.
10. Clinically significant cardiovascular disease
11. Pregnant or nursing females.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
3/07/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
3/01/2023
Sample size
Target
Accrual to date
Final
136
Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
Recruitment hospital [1] 0 0
Gosford Hospital - Gosford
Recruitment hospital [2] 0 0
Monash Health - Clayton
Recruitment hospital [3] 0 0
Ballarat Oncology and Haematology Services - Wendouree
Recruitment hospital [4] 0 0
St John of God Health Care - Subiaco
Recruitment postcode(s) [1] 0 0
2250 - Gosford
Recruitment postcode(s) [2] 0 0
3168 - Clayton
Recruitment postcode(s) [3] 0 0
3355 - Wendouree
Recruitment postcode(s) [4] 0 0
6008 - Subiaco
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Florida
Country [2] 0 0
United States of America
State/province [2] 0 0
Indiana
Country [3] 0 0
United States of America
State/province [3] 0 0
Kansas
Country [4] 0 0
United States of America
State/province [4] 0 0
Kentucky
Country [5] 0 0
United States of America
State/province [5] 0 0
North Carolina
Country [6] 0 0
United States of America
State/province [6] 0 0
Oregon
Country [7] 0 0
Belgium
State/province [7] 0 0
Brugge
Country [8] 0 0
Belgium
State/province [8] 0 0
Leuven
Country [9] 0 0
China
State/province [9] 0 0
Anhui
Country [10] 0 0
China
State/province [10] 0 0
Beijing
Country [11] 0 0
China
State/province [11] 0 0
Guangdong
Country [12] 0 0
China
State/province [12] 0 0
Jiangsu
Country [13] 0 0
China
State/province [13] 0 0
Liaoning
Country [14] 0 0
China
State/province [14] 0 0
Shandong
Country [15] 0 0
China
State/province [15] 0 0
Shanghai
Country [16] 0 0
Czechia
State/province [16] 0 0
Praha
Country [17] 0 0
France
State/province [17] 0 0
Brest
Country [18] 0 0
France
State/province [18] 0 0
Doubs
Country [19] 0 0
France
State/province [19] 0 0
Lyon
Country [20] 0 0
France
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Montpellier
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France
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Plerin
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France
State/province [22] 0 0
Rennes
Country [23] 0 0
France
State/province [23] 0 0
SaintHerblain
Country [24] 0 0
France
State/province [24] 0 0
Toulouse
Country [25] 0 0
France
State/province [25] 0 0
Villejuif
Country [26] 0 0
Georgia
State/province [26] 0 0
Tbilisi
Country [27] 0 0
Hong Kong
State/province [27] 0 0
Hong Kong
Country [28] 0 0
Hungary
State/province [28] 0 0
Budapest
Country [29] 0 0
Hungary
State/province [29] 0 0
Pecs
Country [30] 0 0
Japan
State/province [30] 0 0
Fukuoka
Country [31] 0 0
Japan
State/province [31] 0 0
Nara
Country [32] 0 0
Japan
State/province [32] 0 0
Oita
Country [33] 0 0
Japan
State/province [33] 0 0
Osaka
Country [34] 0 0
Japan
State/province [34] 0 0
Saitama
Country [35] 0 0
Japan
State/province [35] 0 0
Tokyo
Country [36] 0 0
Poland
State/province [36] 0 0
Gdynia
Country [37] 0 0
Poland
State/province [37] 0 0
Lublin
Country [38] 0 0
Poland
State/province [38] 0 0
Warszawa
Country [39] 0 0
Poland
State/province [39] 0 0
Wieliszew
Country [40] 0 0
Russian Federation
State/province [40] 0 0
Arkhangel'skaya Oblast'
Country [41] 0 0
Russian Federation
State/province [41] 0 0
Kurskaya Oblast'
Country [42] 0 0
Russian Federation
State/province [42] 0 0
Omskaya Oblast'
Country [43] 0 0
Russian Federation
State/province [43] 0 0
Sankt-Peterburg
Country [44] 0 0
Russian Federation
State/province [44] 0 0
Volgogradskaya Oblast'
Country [45] 0 0
Singapore
State/province [45] 0 0
Singapore
Country [46] 0 0
Spain
State/province [46] 0 0
Barcelona
Country [47] 0 0
Spain
State/province [47] 0 0
Madrid
Country [48] 0 0
Spain
State/province [48] 0 0
Majadahonda
Country [49] 0 0
Spain
State/province [49] 0 0
Pamplona
Country [50] 0 0
Spain
State/province [50] 0 0
Valencia
Country [51] 0 0
Taiwan
State/province [51] 0 0
Tainan
Country [52] 0 0
United Kingdom
State/province [52] 0 0
London
Country [53] 0 0
United Kingdom
State/province [53] 0 0
Wirral

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Study Director
Address 0 0
BeiGene
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT03427814