Advanced or Inoperable Gastric Cancer Clinical Trial
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
| Verified date | August 2023 |
| Source | BeiGene |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 136 |
| Est. completion date | January 3, 2023 |
| Est. primary completion date | June 18, 2020 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| 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. 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 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. |
| Country | Name | City | State |
|---|---|---|---|
| Australia | Monash Health | Clayton | Victoria |
| Australia | The Townsville Hospital and Health Service | Douglas | Queensland |
| Australia | Northern Hospital | Epping | Victoria |
| Australia | Central Coast Local Health District | Gosford | New South Wales |
| Australia | Ballarat Oncology and Haematology Services | Wendouree | Victoria |
| Belgium | AZ Sint-Jan Brugge - Oostende AV - Campus Sint-Jan - Oncology | Brugge | West-Vlaanderen |
| Belgium | AZ Maria Middelares - Campus Maria Middelares | Gent | Oost-Vlaanderen |
| Belgium | UZ Gent | Gent | Oost-Vlaanderen |
| Belgium | University Hospitals Leuven | Leuven | Vlaams Brabant |
| Belgium | CHU de Liège - Domaine Universitaire du Sart Tilman | Liège | |
| Belgium | UZ Antwerpen | Wilrijk | Antwerpen |
| China | Beijing Cancer Hospital - Digestive Tumor Medical | Beijing | Beijing |
| China | Hunan Cancer Hospital | Changsha | Hunan |
| China | Guangdong General Hospital | Guangzhou | Guangdong |
| China | Nanfang Hospital | Guangzhou | Guangdong |
| China | Sun Yat-sen University - Cancer Center (SYSUCC) | Guangzhou | |
| China | The Sixth Affiliated Hospital of Sun Yat-sen University | Guangzhou | Guangdong |
| China | Harbin Medical University Cancer Hospital - Oncology | Haerbin | Heilongjiang |
| China | Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine | Hangzhou | Zhejiang |
| China | The Second Affiliated Hospital of Zhejiang University | Hangzhou | Zhejiang |
| China | Zhejiang Cancer Hospital | Hangzhou | Zhejiang |
| China | Anhui Medical University - The Second Hospital | Hefei | Anhui |
| China | The First Affiliated Hospital of Anhui Medical University | Hefei | Anhui |
| China | 1st Affiliated Hospital of Nanjing Medical U | Nanjing | Jiangsu |
| China | Nanjing Drum Tower Hospital | Nanjing | |
| China | The Affiliated Hospital Of Qingdao University | Qingdao | Shandong |
| China | Zhongshan Hospital Fudan University | Shanghai | Shanghai |
| China | Cancer Hospital of Shantou University Medical College - Oncology | Shantou | Guangdong |
| China | Liaoning Cancer Hospital & Institute - Medical Oncology | Shenyang | Liaoning |
| China | The Second Affiliated Hospital of Soochow University | Suzhou | Jiangsu |
| China | Tianjin Cancer Hospital | Tianjin | Tianjin |
| China | The First Affiliated Hospital of Xiamen University | Xiamen | Fujian |
| China | The First Affiliated Hospital of Xinxiang Medical University | Xinxiang | Henan |
| China | The Affiliated Hospital of Xuzhou Medical University | Xuzhou | Jiangsu |
| China | Northern Jiangsu people's hospital - Oncology | Yangzhou | Jiangsu |
| China | The first affiliated hospital of Zhengzhou University - Oncology - Oncology | Zhengzhou | Henan |
| Czechia | Fakultni nemocnice Olomouc | Olomouc | |
| Czechia | Thomayerova nemocnice | Praha | |
| France | Institut de Cancérologie de l'Ouest | Angers Cedex 02 | |
| France | ICO | Angers Cedex 2 | |
| France | University Hospital of Besançon | Besançon cedex | Franche-Comté |
| France | Hôpital Morvan - CHRU de Brest | Brest Cedex | Bretagne |
| France | Hopital Privé Jean Mermoz | Lyon | Rhône |
| France | ICM Val d'Aurelle | Montpellier Cedex 5 | Languedoc-Roussillon |
| France | CHU Nice - Hôpital de l'Archet 2 | Nice Cedex 3 | Alpes Maritimes |
| France | Pitié Salpetriere - Gastroenterology | Paris cedex 13 | Île-de-France |
| France | Hôpital Privé des Côtes d'Armor - Service oncologie | Plérin | Bretagne |
| France | Hospital of Poitiers | Poitiers | Vienne |
| France | Centre Eugène Marquis | Rennes | Ille-et-Vilaine |
| France | Centre Hospitalier Universitaire (CHU) de Toulouse - Hopital | Toulouse cedex 9 | Haute-Garonne |
| France | Institut Gustave Roussy | Villejuif | Île-de-France |
| Georgia | LTD Acad.F.Todua Medical Center -Research Institute of Clinical Medicine | Melkadze | Tamar |
| Georgia | Multiprofile Clinic Consilium Medulla LTD | Tbilisi | |
| Georgia | Scientific Research Center of Oncology LTD | Tbilisi | |
| Hong Kong | Queen Mary Hospital | Hong Kong | |
| Hungary | Országos Onkológiai Intézet | Budapest | |
| Hungary | Semmelweis Egyetem | Budapest | |
| Hungary | Semmelweis Egyetem | Budapest | |
| Hungary | Debreceni Egyetem Klinikai Központ | Debrecen | |
| Hungary | Szabolcs-Szatmár-Bereg Megyei Kórházak és Egyetemi Oktatókór | Nyíregyháza | Szabolcs-Szatmár-Bereg |
| Hungary | Pécsi Tudományegyetem Klinikai Központ | Pécs | |
| Hungary | Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz - Rendeloint | Szolnok | Jász-Nagykun-Szolnok |
| Japan | National Cancer Center Hospital | Chuo Ku | |
| Japan | National Hospital Organization Kyushu Cancer Center | Fukuoka | |
| Japan | Kansai Medical University Hospital | Hirakata | |
| Japan | Hyogo College of Medicine College Hospital | Hyogo | |
| Japan | Kindai University Hospital | Kawakami | Histao |
| Japan | St. Marianna University School of Medicine Hospital | Kawasaki | Kanagawa |
| Japan | Japan Community Health Care Organization (JCHO) Kyushu Hospital - Hospital | Kitakyushu-shi | Hukuoka [Fukuoka] |
| Japan | Kumamoto University Hospital | Kumamoto | |
| Japan | Aichi Cancer Center Hospital - Clinical Oncology | Nagoya | Aiti [Aichi] |
| Japan | National Hospital Organization - Osaka National Hospital | Osaka | |
| Japan | Osaki Citizen Hospital | Osaka | |
| Japan | Osaka International Cancer Institute - Medical Oncology | Osaka-shi | |
| Japan | Saitama Cancer Center | Saitama | |
| Japan | Hokkaido University Hospital | Sapporo | |
| Japan | Osaka University Hospital - Medical Oncology | Suita | Osaka |
| Japan | Osaka Medical College Hospital | Takatsuki | |
| Japan | Tochigi Cancer Center | Utsunomiya | |
| Poland | Szpital Specjalist. w Brzozowie,Podkarpacki Osrodek Onkologi | Brzozow | Podkarpackie |
| Poland | Szpitale Pomorskie Sp. z o.o. | Gdynia | |
| Poland | Salve Medica | Lódz | Lódzkie |
| Poland | Centrum Onkologii Ziemi Lubelskiej im. sw. Jana z Dukli | Lublin | |
| Poland | Clinical Research Center Sp. z o.o., Medic-R Sp. K. | Poznan | |
| Poland | Mazowiecki Szpital Onkologiczny | Wieliszew | Mazowieckie |
| Romania | Gral Medical | Bucuresti | |
| Romania | Med Life | Bucuresti | |
| Romania | Medisprof | Cluj-Napoca | |
| Romania | Spitalul Clinic Judetean de Urgenta "Sf. Apostol Andrei" Constanta | Constanta | |
| Romania | Oncolab | Craiova | |
| Russian Federation | Guz Clinical Oncology Dispensary #1 | Krasnodar | Krasnodarskiy Kray |
| Russian Federation | Guz Clinical Oncology Dispensary #1 | Krasnodar | |
| Russian Federation | Main Military Hospital n.a. Burdenko | Moscow | |
| Russian Federation | GUZ Perm Regional Oncology Dispensary | Perm | |
| Russian Federation | GBOU VPO NorthWestern State Medical University n.a. I.I. Mec | Saint Petersburg | |
| Russian Federation | N.N. Petrov Research Institute of Oncology | Saint Petersburg | |
| Russian Federation | Samara Regional Clinical Oncology Dispensary : | Samara | |
| Russian Federation | GBUZ "Regional clinical oncologic dispensary of Volgograd" | Volgograd | |
| Singapore | National Cancer Centre | Singapore | Central Singapore |
| Singapore | National Cancer Centre Singapore | Singapore | |
| Singapore | Raffles Hospital | Singapore | Central Singapore |
| Singapore | Tan Tock Seng Hospital - Oncology | Singapore | Central Singapore |
| Spain | Hospital Universitario Fundación Jiménez Díaz | Alcorcon | Madrid |
| Spain | Hospital Universitario Fundacion Alcorcon | Alcorcón | |
| Spain | Hospital de La Santa Creu i Sant Pau | Barcelona | |
| Spain | Hospital del Mar | Barcelona | |
| Spain | Hospital Universitario Vall d'Hebrón | Barcelona | |
| Spain | Institut Catalá d´Oncología (I.C.O.) | L'Hospitalet de Llobregat | Barcelona |
| Spain | Hospital General Universitario Gregorio Marañon | Madrid | |
| Spain | Hospital Madrid Norte Sanchinarro | Madrid | |
| Spain | Hospital Universitario Gregorio Marañon | Madrid | |
| Spain | Hospital Universitario Ramón Y Cajal | Madrid | |
| Spain | Clínica Universidad de Navarra | Pamplona | Navarra |
| Spain | Hospital Universitario Virgen Macarena. | Sevilla | |
| Spain | Hospital Clínico de Valencia | Valencia | |
| Spain | Hospital Universtiario Miguel Servet. | Zaragoza | |
| Taiwan | Chi Mei Medical Center | Tainan | |
| Taiwan | Tri-Service General Hospital | Taipei | |
| Taiwan | Tri-Service General Hospital - Neihu Branch - Hematology | Taipei | |
| United Kingdom | Guy's and St Thomas NHS Foundation Trust | London | |
| United Kingdom | NHS - Guy's & St Thomas' Hospital - Medical Oncology | London | Greater London |
| United Kingdom | Royal Berkshire Hospital | London | |
| United Kingdom | Sarah Cannon Research Institute UK | London | Greater London |
| United Kingdom | East and North Hertfordshire NHS Trust | Northwood | |
| United Kingdom | Mount Vernon Hospital | Northwood | |
| United Kingdom | Nottingham University Hospitals NHS Trust | Nottingham | Nottinghamshire |
| United Kingdom | Peterborough And Stamford Hospitals | Peterborough | |
| United Kingdom | Peterborough And Stamford Hospitals - Haematology & Oncology | Peterborough | |
| United States | Novant Health & Presbyterian Healthcare - Presbyterian Hospi | Charlotte | North Carolina |
| United States | Goshen Center for Cancer Care | Goshen | Indiana |
| United States | Norton Cancer Institute | Louisville | Kentucky |
| United States | Baptist Health Medical Group Oncology, LLC - Research Center | Miami | Florida |
| United States | Sylvester Comprehensive Cancer Center | Miami | Florida |
| United States | The Sarah Cannon Research Institute | Nashville | Tennessee |
| United States | Vanderbilt University Medical Center (VUMC) | Nashville | Tennessee |
| United States | Stephenson Cancer Center - Oncology | Oklahoma City | Oklahoma |
| United States | Oregon Health and Science University Knight Cancer Institute - Hematology Medical Oncology - Hematology Medical Oncology | Portland | Oregon |
| United States | St Joseph Heritage Healthcare | Santa Rosa | California |
| United States | Renovatio Clincal | The Woodlands | Texas |
| United States | Florida Cancer Specialists - Hematology/Oncology | West Palm Beach | Florida |
| United States | Cancer Center of Kansas | Wichita | Kansas |
| Lead Sponsor | Collaborator |
|---|---|
| BeiGene |
United States, Australia, Belgium, China, Czechia, France, Georgia, Hong Kong, Hungary, Japan, Poland, Romania, Russian Federation, Singapore, Spain, Taiwan, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| 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. | Approximately 23 months | |
| Secondary | Overall Survival (OS) | OS is defined as the time from randomization to death due to any cause. | 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 | 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 | 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 | 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 | Approximately 23 months | |
| Secondary | 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) |