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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT03427814
Ethics application status
Date submitted
5/02/2018
Date registered
9/02/2018
Date last updated
20/05/2020

Titles & IDs
Public title
Study of BGB-290 or Placebo in Participants With Advanced or Inoperable Gastric Cancer
Scientific title
PARALLEL 303: 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 - Approximately 270 subjects to receive pamiparib orally.

Placebo Comparator: Placebo - Approximately 270 subjects to receive placebo orally.


Treatment: Drugs: pamiparib
60 mg PO BID

Treatment: Drugs: Placebo
60 mg PO BID

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

Outcomes
Primary outcome [1] 0 0
Progression free survival - The primary objective of this study is to compare progression free survival between treatment groups (BGB-290 versus placebo) as determined by blinded independent central review.
Timepoint [1] 0 0
From randomization to the date of first documentation of disease progression or death due to any cause, whichever occurs first up to 5 years
Secondary outcome [1] 0 0
Overall survival between treatment groups (BGB-290 versus placebo)
Timepoint [1] 0 0
From time of randomization until date of death due to any cause assessed, up to 2.5 years
Secondary outcome [2] 0 0
Progression free survival between treatment groups determined by investigator assessment
Timepoint [2] 0 0
From randomization to the date of first documentation of disease progression or death due to any cause, whichever occurs first, up to 2.5 years
Secondary outcome [3] 0 0
Progression free survival on subsequent treatment (PFS2)
Timepoint [3] 0 0
From the time of randomization to second disease progression, or death from any cause, whichever is first, up to 2.5 years
Secondary outcome [4] 0 0
Time to second subsequent treatment
Timepoint [4] 0 0
From the time from randomization until the second subsequent anti-cancer therapy or death after next-line therapy, up to 2.5 years
Secondary outcome [5] 0 0
Objective response rate by investigator assessment
Timepoint [5] 0 0
From randomization to first documentation of disease progression assessed up to 2.5 years
Secondary outcome [6] 0 0
Duration of response by investigator assessment
Timepoint [6] 0 0
The time from the first documented confirmed response of CR or PR to PD or death due to any cause, whichever occurs first, up to 2.5 years
Secondary outcome [7] 0 0
Time to response by investigator assessment
Timepoint [7] 0 0
Defined as the time from randomization to the first documented confirmed response of CR or PR assessed up to 2.5 years
Secondary outcome [8] 0 0
Incidence, nature and severity of adverse events between treatment groups
Timepoint [8] 0 0
From time of randomization to approximately 30 days after end of treatment

Eligibility
Key inclusion criteria
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. 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.
Minimum age
18 Years
Maximum age
99 Years
Gender
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) or active bleeding disorder.

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.

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
Active, not 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,VIC
Recruitment hospital [1] 0 0
Central Coast Local Health District - Gosford
Recruitment hospital [2] 0 0
Monash Health - Clayton
Recruitment hospital [3] 0 0
Northern Hospital - Epping
Recruitment hospital [4] 0 0
Ballarat Oncology and Haematology Services - Wendouree
Recruitment postcode(s) [1] 0 0
2250 - Gosford
Recruitment postcode(s) [2] 0 0
3168 - Clayton
Recruitment postcode(s) [3] 0 0
3076 - Epping
Recruitment postcode(s) [4] 0 0
3355 - Wendouree
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Indiana
Country [4] 0 0
United States of America
State/province [4] 0 0
Kansas
Country [5] 0 0
United States of America
State/province [5] 0 0
Kentucky
Country [6] 0 0
United States of America
State/province [6] 0 0
North Carolina
Country [7] 0 0
United States of America
State/province [7] 0 0
Oregon
Country [8] 0 0
United States of America
State/province [8] 0 0
Tennessee
Country [9] 0 0
Belgium
State/province [9] 0 0
Oost-Vlaanderen
Country [10] 0 0
Belgium
State/province [10] 0 0
Vlaams Brabant
Country [11] 0 0
Belgium
State/province [11] 0 0
West-Vlaanderen
Country [12] 0 0
China
State/province [12] 0 0
Anhui
Country [13] 0 0
China
State/province [13] 0 0
Beijing
Country [14] 0 0
China
State/province [14] 0 0
Fujian
Country [15] 0 0
China
State/province [15] 0 0
Guangdong
Country [16] 0 0
China
State/province [16] 0 0
Jiangsu
Country [17] 0 0
China
State/province [17] 0 0
Liaoning
Country [18] 0 0
China
State/province [18] 0 0
Shandong
Country [19] 0 0
China
State/province [19] 0 0
Shanghai
Country [20] 0 0
China
State/province [20] 0 0
Tianjin
Country [21] 0 0
China
State/province [21] 0 0
Zhejiang
Country [22] 0 0
China
State/province [22] 0 0
Guangzhou
Country [23] 0 0
China
State/province [23] 0 0
Nanjing
Country [24] 0 0
France
State/province [24] 0 0
Bretagne
Country [25] 0 0
France
State/province [25] 0 0
Franche-Comté
Country [26] 0 0
France
State/province [26] 0 0
Haute-Garonne
Country [27] 0 0
France
State/province [27] 0 0
Ille-et-Vilaine
Country [28] 0 0
France
State/province [28] 0 0
Languedoc-Roussillon
Country [29] 0 0
France
State/province [29] 0 0
Rhône
Country [30] 0 0
France
State/province [30] 0 0
Vienne
Country [31] 0 0
France
State/province [31] 0 0
Angers Cedex 02
Country [32] 0 0
France
State/province [32] 0 0
Île-de-France
Country [33] 0 0
Hong Kong
State/province [33] 0 0
Hong Kong
Country [34] 0 0
Hungary
State/province [34] 0 0
Jász-Nagykun-Szolnok
Country [35] 0 0
Hungary
State/province [35] 0 0
Szabolcs-Szatmár-Bereg
Country [36] 0 0
Hungary
State/province [36] 0 0
Budapest
Country [37] 0 0
Hungary
State/province [37] 0 0
Pécs
Country [38] 0 0
Japan
State/province [38] 0 0
Aiti [Aichi]
Country [39] 0 0
Japan
State/province [39] 0 0
Hukuoka [Fukuoka]
Country [40] 0 0
Japan
State/province [40] 0 0
Kanagawa
Country [41] 0 0
Japan
State/province [41] 0 0
Osaka
Country [42] 0 0
Japan
State/province [42] 0 0
Osaka-shi
Country [43] 0 0
Poland
State/province [43] 0 0
Mazowieckie
Country [44] 0 0
Poland
State/province [44] 0 0
Gdynia
Country [45] 0 0
Poland
State/province [45] 0 0
Lublin
Country [46] 0 0
Singapore
State/province [46] 0 0
Central Singapore
Country [47] 0 0
Spain
State/province [47] 0 0
Barcelona
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Spain
State/province [48] 0 0
Madrid
Country [49] 0 0
Spain
State/province [49] 0 0
Navarra
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Spain
State/province [50] 0 0
Valencia
Country [51] 0 0
Taiwan
State/province [51] 0 0
Tainan
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Taiwan
State/province [52] 0 0
Taipei
Country [53] 0 0
United Kingdom
State/province [53] 0 0
Greater London
Country [54] 0 0
United Kingdom
State/province [54] 0 0
Nottinghamshire
Country [55] 0 0
United Kingdom
State/province [55] 0 0
Northwood
Country [56] 0 0
United Kingdom
State/province [56] 0 0
Peterborough

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

Ethics approval
Ethics application status

Summary
Brief summary
This study will enroll subjects with previously-treated advanced or inoperable gastric cancer
who have responded to first line platinum therapy into two treatment arms. In Arm A subjects
will receive BGB-290; in Arm B subjects will receive placebo. The purpose of this study is to
show that BGB-290 (versus placebo) will improve progression-free survival (PFS) in subjects
with advanced or inoperable gastric cancer.
Trial website
https://clinicaltrials.gov/show/NCT03427814
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Maggie Zhang, PharmD
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

Summary results
Other publications