Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2017-003493-13 | EudraCT Number | ||
| CTR20171664 | Registry Identifier | Center for drug evaluation NMPA |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pamiparib | Experimental | Participants received pamiparib orally. |
|
| Placebo | Placebo Comparator | Participants received placebo orally. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pamiparib | Drug | 60 mg orally twice daily |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Approximately 23 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | OS is defined as the time from randomization to death due to any cause. | 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 |
Not provided
Key Inclusion Criteria:
Key Exclusion Criteria:
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Study Director | BeiGene | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Miami Cancer Institute | Miami | Florida | 33176 | United States | ||
| Scri Florida Cancer Specialist East |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Participants were enrolled in multiple study centers in Asia, Australia, Europe, and North America.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Pamiparib | Participants received 60 milligrams (mg) pamiparib orally twice a day until progressive disease, unacceptable toxicity, death, or withdrawal of consent for study treatment, investigator's discretion, start of new anticancer therapy or Sponsor's decision to end the study |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 14, 2020 | Aug 22, 2023 |
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug | 60 mg orally twice daily |
|
| 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 | 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 | 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 | Approximately 23 months |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | 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) |
| West Palm Beach |
| Florida |
| 33401 |
| United States |
| Goshen Center For Cancer Care | Goshen | Indiana | 46526 | United States |
| Cancer Center of Kansas | Wichita | Kansas | 67214 | United States |
| Norton Cancer Institute | Louisville | Kentucky | 40217 | United States |
| Novant Health Hematology Charlotte | Charlotte | North Carolina | 28204 | United States |
| Oregon Health and Science University | Portland | Oregon | 97239 | United States |
| Gosford Hospital | Gosford | New South Wales | 2250 | Australia |
| Monash Health | Clayton | Victoria | 3168 | Australia |
| Ballarat Oncology and Haematology Services | Wendouree | Victoria | 3355 | Australia |
| St John of God Health Care | Subiaco | Western Australia | 6008 | Australia |
| Az Sint Jan Brugge | Bruges | 8000 | Belgium |
| University Hospitals Leuven | Leuven | 3000 | Belgium |
| Anhui Provincial Hospital | Hefei | Anhui | 230000 | China |
| Beijing Cancer Hospital | Beijing | Beijing Municipality | 100142 | China |
| Sun Yat Sen University Cancer Center | Guangzhou | Guangdong | 510060 | China |
| Nanfang Hospital of Southern Medical University | Guangzhou | Guangdong | 510515 | China |
| Cancer Hospital of Shantou University Medical College | Shantou | Guangdong | 515031 | China |
| Nanjing Drum Tower Hospital,the Affiliated Hospital of Nanjing University Medical School | Nanjing | Jiangsu | 210008 | China |
| Liaoning Cancer Hospital and Institute | Shenyang | Liaoning | 110042 | China |
| Shandong Cancer Hospital | Jinan | Shandong | 250117 | China |
| The Affiliated Hospital of Qingdao University Branch South | Qingdao | Shandong | 266000 | China |
| Affiliated Zhongshan Hospital of Fudan University | Shanghai | Shanghai Municipality | 200032 | China |
| Fakultni Nemocnice Bulovka | Prague | 18081 | Czechia |
| Chru de Brest Hospital Morvan | Brest | 29200 | France |
| Chu Besancon Hopital Jean Minjoz | Doubs | 25030 | France |
| Hopital Prive Jean Mermoz | Lyon | 69008 | France |
| Icm Val Daurelle Oncologie Medicale | Montpellier | 24298 | France |
| Hopital Prive Des Cotes Darmor Service Oncologie | Plérin | 22190 | France |
| Centre Eugene Marquis | Rennes | 35043 | France |
| Ico Site Rene Gauducheau | SaintHerblain | 44805 | France |
| Iuc Toulouse Oncopole | Toulouse | 31059 | France |
| Institut Gustave Roussy | Villejuif | 94805 | France |
| Acad Fridon Todua Medical Center Ltd Research Institute of Clinical Medicine Ltd | Tbilisi | 0112 | Georgia |
| Queen Mary Hospital | Hong Kong | Hong Kong |
| Orszagos Onkologiai Intezet | Budapest | 1122 | Hungary |
| Pecsi Tudomanyegyetem Klinikai Kozpont | Pécs | H-7624 | Hungary |
| Nho Kyushu Cancer Center | Fukuoka | Fukuoka | 811-1395 | Japan |
| Kindai University Nara Hospital | Ikoma | Nara | 630-0293 | Japan |
| Oita University Hospital | Yufushi | Oita Prefecture | 879-5593 | Japan |
| Kindai University Hospital | Sayama | Osaka | 589-8511 | Japan |
| Osaka University Hospital | Suitashi | Osaka | 565-0871 | Japan |
| Saitama Medical University International Medical Center | Hidakashi | Saitama | 350-1298 | Japan |
| Showa University Koto Toyosu Hospital Oncology | Koto | Tokyo | 135-8577 | Japan |
| Szpitale Pomorskie Spolka Z Ograniczona Odpowiedzialnoscia | Gdynia | 81-519 | Poland |
| Centrum Onkologii Ziemi Lubelskiej | Lublin | 20-090 | Poland |
| Narodowy Instytut Onkologii Im Marii Skodowskiej Curie Pastwowy Instytut Badawczy | Warsaw | 02-034 | Poland |
| Mazowiecki Szpital Onkologiczny | Wieliszew | 05-135 | Poland |
| Arkhangelsk Regional Clinical Oncological Dispensary | Arkhangelsk | Arkhangelskaya oblast | 163045 | Russia |
| Regional Buz Kurskiy Regional Clinical Oncologic Dispensary | Kursk | Kursk Oblast | 305035 | Russia |
| Bih of Omsk Region Clinical Oncology Dispensary | Omsk | Omsk Oblast | 644013 | Russia |
| Pavlov First Saint Petersburg State Medical University | SaintPetersburg | Sankt-Peterburg | 197022 | Russia |
| State Budgetary Healthcare Institution Volgograd Regional Clinical Oncology Dispensary | Volgograd | Volgograd Oblast | 400138 | Russia |
| Tan Tock Seng Hospital Oncology | Singapore | 308433 | Singapore |
| Hospital de La Santa Creu I Sant Pau | Barcelona | 08025 | Spain |
| Hospital Universitario Vall Dhebron | Barcelona | 08035 | Spain |
| Institut Catala Doncologia | Barcelona | 08908 | Spain |
| Hospital Universitario Ramon Y Cajal | Madrid | 28034 | Spain |
| Hospital Universitario Hm Madrid Sanchinarro | Madrid | 28050 | Spain |
| Hospital Universitario Puerta de Hierro Majadahonda | Majadahonda | 28222 | Spain |
| Clinica Universidad de Navarra Pamplona | Pamplona | 31008 | Spain |
| Hospital Clinico Universitario de Valencia | Valencia | 46010 | Spain |
| Chi Mei Medical Center | Tainan | 710 | Taiwan |
| Sarah Cannon Research Institute Uk | London | W1G 6AD | United Kingdom |
| Clatterbridge Cancer Centre | Metropolitan Borough of Wirral | CH63 4JY | United Kingdom |
| Placebo |
Participants received 60 mg placebo orally twice daily until progressive disease, unacceptable toxicity, death, withdrawal of consent for study treatment, investigator's discretion, start of new anticancer therapy, or Sponsor's decision to end the study |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Intent to Treat (ITT) Analysis Set included all randomized participants who were assigned to a study drug (pamiparib or placebo)
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Pamiparib | Participants received 60 mg pamiparib orally twice a day until progressive disease, unacceptable toxicity, death, or withdrawal of consent for study treatment, investigator's discretion, start of new anticancer therapy or Sponsor's decision to end the study |
| BG001 | Placebo | Participants received 60 mg placebo orally twice daily until progressive disease, unacceptable toxicity, death, withdrawal of consent for study treatment, investigator's discretion, start of new anticancer therapy, or Sponsor's decision to end the study |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Intent To Treat (ITT) Analysis Set | Posted | Median | 95% Confidence Interval | Months | Approximately 23 months |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) | OS is defined as the time from randomization to death due to any cause. | ITT Analysis Set | Posted | Median | 95% Confidence Interval | Months | Approximately 23 months |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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 | ITT Analysis Set | Posted | Median | 95% Confidence Interval | Months | Approximately 23 months |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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 | Efficacy Evaluable Analysis Set includes all randomized participants who had measurable disease at baseline and had at least one post baseline tumor assessment unless discontinued treatment due to clinical progression or death prior to tumor assessment | Posted | Number | 95% Confidence Interval | Percentage of participants | Approximately 23 months |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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 | Efficacy Evaluable Analysis Set; Only responders were included in the analysis. | Posted | Median | 95% Confidence Interval | Months | Approximately 23 months |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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 | Efficacy Evaluable Analysis Set; Only responders were included in the analysis. | Posted | Median | Full Range | Months | Approximately 23 months |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Safety Analysis Set includes all participants in the ITT Analysis Set who receive at least one dose of study treatment (pamiparib or placebo). | Posted | Number | Number of participants | 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) |
|
|
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)
Safety Analysis Set includes all participants in the ITT Analysis Set who receive at least one dose of study treatment (pamiparib or placebo).
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pamiparib | Participants received 60 mg pamiparib orally twice a day until progressive disease, unacceptable toxicity, death, or withdrawal of consent for study treatment, investigator's discretion, start of new anticancer therapy or Sponsor's decision to end the study | 42 | 71 | 17 | 71 | 65 | 71 |
| EG001 | Placebo | Participants received 60 mg placebo orally twice daily until progressive disease, unacceptable toxicity, death, withdrawal of consent for study treatment, investigator's discretion, start of new anticancer therapy, or Sponsor's decision to end the study | 31 | 65 | 11 | 65 | 57 | 65 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Malignant dysphagia | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Obstruction gastric | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Subileus | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Death | General disorders | MedDRA 25.0 | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Jaundice | Hepatobiliary disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Pneumocystis jirovecii infection | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Hepatic rupture | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Postrenal failure | Renal and urinary disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Renal colic | Renal and urinary disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 25.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Odynophagia | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| Blood lactate dehydrogenase increased | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| Weight increased | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Onycholysis | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 25.0 | Systematic Assessment |
|
BeiGene has 18 months from the end of the study at all sites to publish overall study results. After the 1st multi-site publication or the expiration of publication period, Investigators are free to publish/present the results of the study. Investigators must submit all draft publications/presentations to us for review 60 days prior to the planned publication/presentation date. BeiGene may request deletion of its confidential information & may request a further delay to protect its IP rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | BeiGene | +1-877-828-5568 | clinicaltrials@beigene.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 28, 2020 | Aug 22, 2023 | SAP_001.pdf |
| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000707927 | pamiparib |
Not provided
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Black or African America |
|
| Native Hawaiian or Other Pacific Islander |
|
| White |
|
| Other |
|
| Not Reported/Unknown |
|
|
|
| Participants |
|
|
|
|
|