Advanced or Inoperable Gastric CancerPhase 2NCT03427814
Study of BGB-290 or Placebo in Participants With Advanced or Inoperable Gastric Cancer
A Phase 2 study testing Pamiparib in people with Advanced or Inoperable Gastric Cancer, run by BeiGene at 65 sites in 16 countries.
Trial summary
This study enrolled participants with previously-treated advanced or inoperable gastric cancer who have responded to first line platinum therapy into two treatment arms. In Arm A participants received BGB-290; in Arm B participants received placebo. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced or Inoperable Gastric Cancer
- What is being tested?
- Pamiparib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 136 participants
- Where
- 65 sitesin 16 countries
- Study dates
- 3 Jul 2018to 3 Jan 2023
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years.
- Signed informed consent.
- Histologically confirmed inoperable locally advanced or metastatic adenocarcinoma of the stomach or gastroesophageal junction.
- Received platinum based first line chemotherapy for ≤ 28 weeks.
- Confirmed partial response (PR) maintained for ≥ 4 weeks or complete response (CR).
- Able to be randomized to study ≤ 8 weeks after last platinum dose.
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- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1.
- Adequate hematologic, renal and hepatic function.
- Must be able to provide archival tumor tissue for central biomarker assessment.
- 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.
Who cannot join
- Unresolved acute effects of prior therapy ≥ Grade 2.
- Prior treatment with PARP inhibitor.
- Chemotherapy, biologic therapy, immunotherapy or other anticancer therapy ≤ 14 days prior to randomization.
- Major surgery or significant injury ≤ 2 weeks prior to start of study treatment.
- Diagnosis of myelodysplastic syndrome (MDS)
- Other diagnoses of significant malignancy
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- Leptomeningeal disease or brain metastasis
- Inability to swallow capsules or disease affecting gastrointestinal function.
- Active infections requiring systemic treatment.
- Clinically significant cardiovascular disease
- Pregnant or nursing females.
- NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Trial locations and contacts
65 sites in 16 countries.
65 sites in 16 countries
China10 sites
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142
Sun Yat Sen University Cancer Center
Guangzhou, Guangdong, 510060
Nanfang Hospital of Southern Medical University
Guangzhou, Guangdong, 510515
Anhui Provincial Hospital
Hefei, Anhui, 230000
Shandong Cancer Hospital
Jinan, Shandong, 250117
Nanjing Drum Tower Hospital,the Affiliated Hospital of Nanjing University Medical School
Nanjing, Jiangsu, 210008
The Affiliated Hospital of Qingdao University Branch South
Qingdao, Shandong, 266000
Affiliated Zhongshan Hospital of Fudan University
Shanghai, Shanghai Municipality, 200032
Cancer Hospital of Shantou University Medical College
Shantou, Guangdong, 515031
Liaoning Cancer Hospital and Institute
Shenyang, Liaoning, 110042
France9 sites
Chru de Brest Hospital Morvan
Brest, 29200
Chu Besancon Hopital Jean Minjoz
Doubs, 25030
Hopital Prive Jean Mermoz
Lyon, 69008
Icm Val Daurelle Oncologie Medicale
Montpellier, 24298
Hopital Prive Des Cotes Darmor Service Oncologie
Plérin, 22190
Centre Eugene Marquis
Rennes, 35043
Ico Site Rene Gauducheau
SaintHerblain, 44805
Iuc Toulouse Oncopole
Toulouse, 31059
Institut Gustave Roussy
Villejuif, 94805
Spain8 sites
Hospital de La Santa Creu I Sant Pau
Barcelona, 08025
Hospital Universitario Vall Dhebron
Barcelona, 08035
Institut Catala Doncologia
Barcelona, 08908
Hospital Universitario Ramon Y Cajal
Madrid, 28034
Hospital Universitario Hm Madrid Sanchinarro
Madrid, 28050
Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda, 28222
Clinica Universidad de Navarra Pamplona
Pamplona, 31008
Hospital Clinico Universitario de Valencia
Valencia, 46010
United States7 sites
Novant Health Hematology Charlotte
Charlotte, North Carolina, 28204
Goshen Center For Cancer Care
Goshen, Indiana, 46526
Norton Cancer Institute
Louisville, Kentucky, 40217
Miami Cancer Institute
Miami, Florida, 33176
Oregon Health and Science University
Portland, Oregon, 97239
Scri Florida Cancer Specialist East
West Palm Beach, Florida, 33401
Cancer Center of Kansas
Wichita, Kansas, 67214
Japan7 sites
Nho Kyushu Cancer Center
Fukuoka, Fukuoka, 811-1395
Saitama Medical University International Medical Center
Hidakashi, Saitama, 350-1298
Kindai University Nara Hospital
Ikoma, Nara, 630-0293
Showa University Koto Toyosu Hospital Oncology
Koto, Tokyo, 135-8577
Kindai University Hospital
Sayama, Osaka, 589-8511
Osaka University Hospital
Suitashi, Osaka, 565-0871
Oita University Hospital
Yufushi, Oita Prefecture, 879-5593
Russia5 sites
Arkhangelsk Regional Clinical Oncological Dispensary
Arkhangelsk, Arkhangelskaya oblast, 163045
Regional Buz Kurskiy Regional Clinical Oncologic Dispensary
Kursk, Kursk Oblast, 305035
Bih of Omsk Region Clinical Oncology Dispensary
Omsk, Omsk Oblast, 644013
Pavlov First Saint Petersburg State Medical University
SaintPetersburg, Sankt-Peterburg, 197022
State Budgetary Healthcare Institution Volgograd Regional Clinical Oncology Dispensary
Volgograd, Volgograd Oblast, 400138
Australia4 sites
Monash Health
Clayton, Victoria, 3168
Gosford Hospital
Gosford, New South Wales, 2250
St John of God Health Care
Subiaco, Western Australia, 6008
Ballarat Oncology and Haematology Services
Wendouree, Victoria, 3355
Poland4 sites
Szpitale Pomorskie Spolka Z Ograniczona Odpowiedzialnoscia
Gdynia, 81-519
Centrum Onkologii Ziemi Lubelskiej
Lublin, 20-090
Narodowy Instytut Onkologii Im Marii Skodowskiej Curie Pastwowy Instytut Badawczy
Warsaw, 02-034
Mazowiecki Szpital Onkologiczny
Wieliszew, 05-135
Belgium2 sites
Az Sint Jan Brugge
Bruges, 8000
University Hospitals Leuven
Leuven, 3000
Hungary2 sites
Orszagos Onkologiai Intezet
Budapest, 1122
Pecsi Tudomanyegyetem Klinikai Kozpont
Pécs, H-7624
United Kingdom2 sites
Sarah Cannon Research Institute Uk
London, W1G 6AD
Clatterbridge Cancer Centre
Metropolitan Borough of Wirral, CH63 4JY
Georgia1 site
Acad Fridon Todua Medical Center Ltd Research Institute of Clinical Medicine Ltd
Tbilisi, 0112
About this study
Official 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
This study enrolled participants with previously-treated advanced or inoperable gastric cancer who have responded to first line platinum therapy into two treatment arms. In Arm A participants received BGB-290; in Arm B participants received placebo. The purpose of this study is to show that BGB-290 (pamiparib) (versus placebo) will improve progression-free survival (PFS) in participants with advanced or inoperable gastric cancer.
Read the detailed description
This is a double-blind, placebo controlled, randomized multicenter global phase 2 study comparing the efficacy and safety of single agent poly (ADP-ribose) polymerase (PARP) inhibitor BGB-290 to placebo as maintenance therapy in participants with advanced gastric cancer who have responded to first line platinum based chemotherapy. Participants are randomized 1:1 to BGB-290 (Arm A) or placebo (Arm B). Randomization will be stratified by geography, biomarker status, and ECOG performance status.
Participants will undergo tumor assessments at screening and then every 8 weeks, or as clinically indicated. Administration of BGB-290 or placebo will continue until disease progression, unacceptable toxicity, death, or another discontinuation criterion is met.
After end of treatment, long-term follow-up assessments include tumor imaging every 8 weeks for those participants without disease progression, survival status, and new anticancer therapy.
- Conditions
- Advanced or Inoperable Gastric Cancer
- Being tested
- Pamiparib, Placebo
- Keywords
- BGB-290, PARP inhibitor, Phase 2, maintenance therapy, gastric cancer, oral treatment, PARALLEL 303, PARALLEL, BGB290303, BGB-290-303
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PamiparibDrug
Also called BGB-290
60 mg orally twice daily
PlaceboDrug
60 mg orally twice daily
| Study group | Role | What they receive |
|---|---|---|
| Pamiparib | Experimental | Participants received pamiparib orally. Receives: Drug: Pamiparib |
| Placebo | Placebo comparator | Participants received placebo orally. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival (PFS) by Investigator Assessment
PFS is defined as the time from randomization to progressive disease (PD) per Response Evaluation Criteria in Solid Tumors ( RECIST) Version 1.1 by investigator assessment or death due to any cause, whichever occurs first.
Measured: Approximately 23 months
Secondary outcomes (6)
Overall Survival (OS)
OS is defined as the time from randomization to death due to any cause.
Measured: Approximately 23 months
Time To Second Subsequent Treatment (TSST)
TSST is defined as the time from randomization until the second subsequent anticancer therapy or death after next-line therapy
Measured: Approximately 23 months
Objective Response Rate (ORR)
ORR is defined as the percentage of participants with a best overall response of Complete Response or Partial Response per RECIST Version 1.1 by investigator assessment
Measured: Approximately 23 months
Duration of Response (DOR)
DOR is defined as the time from the first documented confirmed response of Complete Response or Partial Response to progressive disease (PD) per RECIST Version 1.1 by investigator assessment or death due to any cause, whichever occurs first
Measured: Approximately 23 months
Time To Response
Time to response is defined as the time from randomization to the first documented response of Complete Response or Partial Response per RECIST Version 1.1 by investigator assessment
Measured: Approximately 23 months
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2018
- Study start3 Jul 2018
- Primary completion18 Jun 2020
- Study completion3 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Advanced or Inoperable Gastric CancerStudies of the same condition, open and under way.
- More trials run by BeiGeneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- BeiGene
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, BeiGene
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03427814
- Sponsor's protocol ID
- BGB-290-303
- Other IDs
- 2017-003493-13, CTR20171664, 2017
- Status last verified
- Oct 2024
- First submitted
- 5 Feb 2018
- Last updated
- 26 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT03427814
- Acronym / sponsor ID
- BGB-290-303
- Conditions
- Advanced or Inoperable Gastric Cancer
- Keywords
- BGB-290, PARP inhibitor, Phase 2, maintenance therapy, gastric cancer, oral treatment, PARALLEL 303, PARALLEL
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- BeiGeneIndustry (pharma, biotech, devices)
- Study start
- 3 Jul 2018 (actual)
- Primary completion
- 18 Jun 2020 (actual)
- Study completion
- 3 Jan 2023 (actual)
- First posted
- 9 Feb 2018 (actual)
- Results
- Posted 21 Sep 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study enrolled participants with previously-treated advanced or inoperable gastric cancer who have responded to first line platinum therapy into two treatment arms. In Arm A participants received BGB-290; in Arm B participants received placebo. The purpose of this study is to show that BGB-290 (pamiparib) (versus placebo) will improve progression-free survival (PFS) in participants with advanced or inoperable gastric cancer.
Detailed description
This is a double-blind, placebo controlled, randomized multicenter global phase 2 study comparing the efficacy and safety of single agent poly (ADP-ribose) polymerase (PARP) inhibitor BGB-290 to placebo as maintenance therapy in participants with advanced gastric cancer who have responded to first line platinum based chemotherapy. Participants are randomized 1:1 to BGB-290 (Arm A) or placebo (Arm B). Randomization will be stratified by geography, biomarker status, and ECOG performance status.
Participants will undergo tumor assessments at screening and then every 8 weeks, or as clinically indicated. Administration of BGB-290 or placebo will continue until disease progression, unacceptable toxicity, death, or another discontinuation criterion is met.
After end of treatment, long-term follow-up assessments include tumor imaging every 8 weeks for those participants without disease progression, survival status, and new anticancer therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pamiparib | Experimental | Drug: PamiparibParticipants received pamiparib orally. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants received placebo orally. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age ≥ 18 years.
- Signed informed consent.
- Histologically confirmed inoperable locally advanced or metastatic adenocarcinoma of the stomach or gastroesophageal junction.
- Received platinum based first line chemotherapy for ≤ 28 weeks.
- Confirmed partial response (PR) maintained for ≥ 4 weeks or complete response (CR).
Key exclusion criteria (12 listed)
- Unresolved acute effects of prior therapy ≥ Grade 2.
- Prior treatment with PARP inhibitor.
- Chemotherapy, biologic therapy, immunotherapy or other anticancer therapy ≤ 14 days prior to randomization.
- Major surgery or significant injury ≤ 2 weeks prior to start of study treatment.
- Diagnosis of myelodysplastic syndrome (MDS)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PamiparibAlso: BGB-29060 mg orally twice daily | Drug | Pamiparib |
| Placebo60 mg orally twice daily | Drug | Placebo |
Primary outcome
Progression Free Survival (PFS) by Investigator Assessment
Time frame: Approximately 23 months
PFS is defined as the time from randomization to progressive disease (PD) per Response Evaluation Criteria in Solid Tumors ( RECIST) Version 1.1 by investigator assessment or death due to any cause, whichever occurs first.
6 secondary outcomes
Overall Survival (OS)
Time frame: Approximately 23 months
Time To Second Subsequent Treatment (TSST)
Time frame: Approximately 23 months
Objective Response Rate (ORR)
Time frame: Approximately 23 months
Duration of Response (DOR)
Time frame: Approximately 23 months
Time To Response
Time frame: Approximately 23 months
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Time frame: 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)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Study Director study director
BeiGene
65 sites in 16 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pamiparib in people with Advanced or Inoperable Gastric Cancer, run by BeiGene at 65 sites in 16 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 65 sites in China, France, Spain, United States, Japan and 11 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Sep 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression Free Survival (PFS) by Investigator Assessment (time frame: Approximately 23 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2024.