Study of BGB-290 or Placebo in Participants With Advanced or Inoperable Gastric Cancer

Sponsor

BeiGene (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT03427814

Collaborator

(none)

136

Enrollment

141

Locations

Arms

50.3

Anticipated Duration (Months)

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study will enroll 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 will receive BGB-290; in Arm B participants will receive placebo. The purpose of this study is to show that BGB-290 (versus placebo) will improve progression-free survival (PFS) in participants with advanced or inoperable gastric cancer.

Condition or Disease	Intervention/Treatment	Phase
Advanced or Inoperable Gastric Cancer	Drug: pamiparib Drug: Placebo	Phase 2

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

Study Type:

Interventional

Actual Enrollment :

136 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official 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

Actual Study Start Date :

Jul 23, 2018

Actual Primary Completion Date :

Sep 16, 2020

Anticipated Study Completion Date :

Sep 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Pamiparib Approximately 64 participants to receive pamiparib orally.	Drug: pamiparib 60 mg PO BID Other Names: BGB-290
Placebo Comparator: Placebo Approximately 64 participants to receive placebo orally.	Drug: Placebo 60 mg PO BID

Arm

Intervention/Treatment

Experimental: Pamiparib

Approximately 64 participants to receive pamiparib orally.

Drug: pamiparib

60 mg PO BID

Other Names:

BGB-290

Placebo Comparator: Placebo

Approximately 64 participants to receive placebo orally.

Drug: Placebo

60 mg PO BID

Outcome Measures

Primary Outcome Measures

Progression free survival [From randomization to the date of first documentation of disease progression or death due to any cause, whichever occurs first up to 5 years]
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.

Secondary Outcome Measures

Overall survival between treatment groups (BGB-290 versus placebo) [From time of randomization until date of death due to any cause assessed, up to 2.5 years]
Progression free survival between treatment groups determined by investigator assessment [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]
Progression free survival on subsequent treatment (PFS2) [From the time of randomization to second disease progression, or death from any cause, whichever is first, up to 2.5 years]
Time to second subsequent treatment [From the time from randomization until the second subsequent anti-cancer therapy or death after next-line therapy, up to 2.5 years]
Objective response rate by investigator assessment [From randomization to first documentation of disease progression assessed up to 2.5 years]
Duration of response by investigator assessment [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]
Time to response by investigator assessment [Defined as the time from randomization to the first documented confirmed response of CR or PR assessed up to 2.5 years]
Incidence, nature and severity of adverse events between treatment groups [From time of randomization to approximately 30 days after end of treatment]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 99 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Key Inclusion Criteria:

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.
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.

Key Exclusion Criteria:

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) or active bleeding disorder.
Other diagnoses of significant malignancy
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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	St Joseph Heritage Healthcare	Santa Rosa	California	United States	95403
2	Sylvester Comprehensive Cancer Center	Miami	Florida	United States	33136
3	Baptist Health Medical Group Oncology, LLC - Research Center	Miami	Florida	United States	33176
4	Florida Cancer Specialists - Hematology/Oncology	West Palm Beach	Florida	United States	33401
5	Goshen Center for Cancer Care	Goshen	Indiana	United States	46526
6	Cancer Center of Kansas	Wichita	Kansas	United States	67214
7	Norton Cancer Institute	Louisville	Kentucky	United States	40217
8	Novant Health & Presbyterian Healthcare - Presbyterian Hospi	Charlotte	North Carolina	United States	28204-3193
9	Stephenson Cancer Center - Oncology	Oklahoma City	Oklahoma	United States	73104
10	Oregon Health and Science University Knight Cancer Institute - Hematology Medical Oncology - Hematology Medical Oncology	Portland	Oregon	United States	97239
11	The Sarah Cannon Research Institute	Nashville	Tennessee	United States	37203
12	Vanderbilt University Medical Center (VUMC)	Nashville	Tennessee	United States	37232
13	Renovatio Clincal	The Woodlands	Texas	United States	77090
14	Central Coast Local Health District	Gosford	New South Wales	Australia	2250
15	The Townsville Hospital and Health Service	Douglas	Queensland	Australia	4814
16	Monash Health	Clayton	Victoria	Australia	3168
17	Northern Hospital	Epping	Victoria	Australia	3076
18	Ballarat Oncology and Haematology Services	Wendouree	Victoria	Australia	3355
19	UZ Antwerpen	Wilrijk	Antwerpen	Belgium	2610
20	AZ Maria Middelares - Campus Maria Middelares	Gent	Oost-Vlaanderen	Belgium	9000
21	UZ Gent	Gent	Oost-Vlaanderen	Belgium	9000
22	University Hospitals Leuven	Leuven	Vlaams Brabant	Belgium	3000
23	AZ Sint-Jan Brugge - Oostende AV - Campus Sint-Jan - Oncology	Brugge	West-Vlaanderen	Belgium	8000
24	CHU de Liège - Domaine Universitaire du Sart Tilman	Liège		Belgium	4000
25	The First Affiliated Hospital of Anhui Medical University	Hefei	Anhui	China	230022
26	Anhui Medical University - The Second Hospital	Hefei	Anhui	China	230601
27	Beijing Cancer Hospital - Digestive Tumor Medical	Beijing	Beijing	China	100142
28	The First Affiliated Hospital of Xiamen University	Xiamen	Fujian	China
29	Guangdong General Hospital	Guangzhou	Guangdong	China	510080
30	Nanfang Hospital	Guangzhou	Guangdong	China	510515
31	The Sixth Affiliated Hospital of Sun Yat-sen University	Guangzhou	Guangdong	China
32	Cancer Hospital of Shantou University Medical College - Oncology	Shantou	Guangdong	China	515031
33	Harbin Medical University Cancer Hospital - Oncology	Haerbin	Heilongjiang	China	150081
34	The First Affiliated Hospital of Xinxiang Medical University	Xinxiang	Henan	China	453100
35	The first affiliated hospital of Zhengzhou University - Oncology - Oncology	Zhengzhou	Henan	China	450052
36	Hunan Cancer Hospital	Changsha	Hunan	China	410013
37	1st Affiliated Hospital of Nanjing Medical U	Nanjing	Jiangsu	China	210029
38	The Second Affiliated Hospital of Soochow University	Suzhou	Jiangsu	China	215000
39	The Affiliated Hospital of Xuzhou Medical University	Xuzhou	Jiangsu	China
40	Northern Jiangsu people's hospital - Oncology	Yangzhou	Jiangsu	China	225001
41	Liaoning Cancer Hospital & Institute - Medical Oncology	Shenyang	Liaoning	China
42	The Affiliated Hospital Of Qingdao University	Qingdao	Shandong	China
43	Zhongshan Hospital Fudan University	Shanghai	Shanghai	China
44	Tianjin Cancer Hospital	Tianjin	Tianjin	China
45	Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine	Hangzhou	Zhejiang	China	310016
46	Zhejiang Cancer Hospital	Hangzhou	Zhejiang	China	310022
47	The Second Affiliated Hospital of Zhejiang University	Hangzhou	Zhejiang	China
48	Sun Yat-sen University - Cancer Center (SYSUCC)	Guangzhou		China	510060
49	Nanjing Drum Tower Hospital	Nanjing		China
50	Fakultni nemocnice Olomouc	Olomouc		Czechia	779 00
51	Thomayerova nemocnice	Praha		Czechia	4 140 59
52	CHU Nice - Hôpital de l'Archet 2	Nice Cedex 3	Alpes Maritimes	France	06200
53	Hôpital Morvan - CHRU de Brest	Brest Cedex	Bretagne	France	29609
54	Hôpital Privé des Côtes d'Armor - Service oncologie	Plérin	Bretagne	France	22190
55	University Hospital of Besançon	Besançon cedex	Franche-Comté	France	25033
56	Centre Hospitalier Universitaire (CHU) de Toulouse - Hopital	Toulouse cedex 9	Haute-Garonne	France	31059
57	Centre Eugène Marquis	Rennes	Ille-et-Vilaine	France	35042
58	ICM Val d'Aurelle	Montpellier Cedex 5	Languedoc-Roussillon	France	34298
59	Hopital Privé Jean Mermoz	Lyon	Rhône	France	69008
60	Hospital of Poitiers	Poitiers	Vienne	France	86021
61	Institut de Cancérologie de l'Ouest	Angers Cedex 02		France	49055
62	ICO	Angers Cedex 2		France	49055
63	Pitié Salpetriere - Gastroenterology	Paris cedex 13	Île-de-France	France	75651
64	Institut Gustave Roussy	Villejuif	Île-de-France	France	94805
65	LTD Acad.F.Todua Medical Center -Research Institute of Clinical Medicine	Melkadze	Tamar	Georgia	0112
66	Multiprofile Clinic Consilium Medulla LTD	Tbilisi		Georgia	186
67	Scientific Research Center of Oncology LTD	Tbilisi		Georgia	186
68	Queen Mary Hospital	Hong Kong		Hong Kong
69	Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz - Rendeloint	Szolnok	Jász-Nagykun-Szolnok	Hungary	5004
70	Szabolcs-Szatmár-Bereg Megyei Kórházak és Egyetemi Oktatókór	Nyíregyháza	Szabolcs-Szatmár-Bereg	Hungary	4400
71	Semmelweis Egyetem	Budapest		Hungary	1083
72	Országos Onkológiai Intézet	Budapest		Hungary	1122
73	Semmelweis Egyetem	Budapest		Hungary	1125
74	Debreceni Egyetem Klinikai Központ	Debrecen		Hungary	4032
75	Pécsi Tudományegyetem Klinikai Központ	Pécs		Hungary	H-7624
76	Aichi Cancer Center Hospital - Clinical Oncology	Nagoya	Aiti [Aichi]	Japan	464-8681
77	Kindai University Hospital	Kawakami	Histao	Japan	589-8511
78	Japan Community Health Care Organization (JCHO) Kyushu Hospital - Hospital	Kitakyushu-shi	Hukuoka [Fukuoka]	Japan	806-8501
79	St. Marianna University School of Medicine Hospital	Kawasaki	Kanagawa	Japan	216-8511
80	Osaka University Hospital - Medical Oncology	Suita	Osaka	Japan	565-0871
81	National Cancer Center Hospital	Chuo Ku		Japan	104-0045
82	National Hospital Organization Kyushu Cancer Center	Fukuoka		Japan	811-1395
83	Kansai Medical University Hospital	Hirakata		Japan	573-1191
84	Hyogo College of Medicine College Hospital	Hyōgo		Japan	663-8501
85	Kumamoto University Hospital	Kumamoto		Japan	860-8556
86	Osaka International Cancer Institute - Medical Oncology	Osaka-shi		Japan	537-8511
87	National Hospital Organization - Osaka National Hospital	Osaka		Japan	540-0006
88	Osaki Citizen Hospital	Osaka		Japan	989-6183
89	Saitama Cancer Center	Saitama		Japan	362-0806
90	Hokkaido University Hospital	Sapporo		Japan	060-8648
91	Osaka Medical College Hospital	Takatsuki		Japan	569-8686
92	Tochigi Cancer Center	Utsunomiya		Japan	3200-834
93	Salve Medica	Łódź	Lódzkie	Poland	93-513
94	Mazowiecki Szpital Onkologiczny	Wieliszew	Mazowieckie	Poland	05-135
95	Szpital Specjalist. w Brzozowie,Podkarpacki Ośrodek Onkologi	Brzozow	Podkarpackie	Poland	36-200
96	Szpitale Pomorskie Sp. z o.o.	Gdynia		Poland	81-519
97	Centrum Onkologii Ziemi Lubelskiej im. sw. Jana z Dukli	Lublin		Poland	20-090
98	Clinical Research Center Sp. z o.o., Medic-R Sp. K.	Poznan		Poland	60-569
99	Med Life	Bucuresti		Romania	03748
100	Gral Medical	Bucuresti		Romania	31422
101	Medisprof	Cluj-Napoca		Romania	400641
102	Spitalul Clinic Judetean de Urgenta "Sf. Apostol Andrei" Constanta	Constanţa		Romania	900591
103	Oncolab	Craiova		Romania	200385
104	Guz Clinical Oncology Dispensary #1	Krasnodar	Krasnodarskiy Kray	Russian Federation	350040
105	Guz Clinical Oncology Dispensary #1	Krasnodar		Russian Federation	35004
106	Main Military Hospital n.a. Burdenko	Moscow		Russian Federation	105229
107	GUZ Perm Regional Oncology Dispensary	Perm		Russian Federation	614066
108	N.N. Petrov Research Institute of Oncology	Saint Petersburg		Russian Federation	191104
109	GBOU VPO NorthWestern State Medical University n.a. I.I. Mec	Saint Petersburg		Russian Federation	195067
110	Samara Regional Clinical Oncology Dispensary :	Samara		Russian Federation	443031
111	GBUZ "Regional clinical oncologic dispensary of Volgograd"	Volgograd		Russian Federation	400138
112	National Cancer Centre	Singapore	Central Singapore	Singapore	169610
113	Raffles Hospital	Singapore	Central Singapore	Singapore	188770
114	Tan Tock Seng Hospital - Oncology	Singapore	Central Singapore	Singapore	308433
115	National Cancer Centre Singapore	Singapore		Singapore	169210
116	Institut Catalá d´Oncología (I.C.O.)	L'Hospitalet de Llobregat	Barcelona	Spain	08907
117	Hospital Universitario Fundación Jiménez Díaz	Alcorcon	Madrid	Spain	28040
118	Clínica Universidad de Navarra	Pamplona	Navarra	Spain	31008
119	Hospital Universitario Fundacion Alcorcon	Alcorcón		Spain	28922
120	Hospital de La Santa Creu i Sant Pau	Barcelona		Spain	08025
121	Hospital Universitario Vall d'Hebrón	Barcelona		Spain	08035
122	Hospital del Mar	Barcelona		Spain	8003
123	Hospital General Universitario Gregorio Marañon	Madrid		Spain	28007
124	Hospital Universitario Gregorio Marañon	Madrid		Spain	28007
125	Hospital Universitario Ramón Y Cajal	Madrid		Spain	28034
126	Hospital Madrid Norte Sanchinarro	Madrid		Spain	28050
127	Hospital Universitario Virgen Macarena.	Sevilla		Spain	41009
128	Hospital Clínico de Valencia	Valencia		Spain	46010
129	Hospital Universtiario Miguel Servet.	Zaragoza		Spain	50009
130	Chi Mei Medical Center	Tainan		Taiwan	710
131	Tri-Service General Hospital - Neihu Branch - Hematology	Taipei		Taiwan	11490
132	Tri-Service General Hospital	Taipei		Taiwan	11490
133	NHS - Guy's & St Thomas' Hospital - Medical Oncology	London	Greater London	United Kingdom	SE1 9RT
134	Sarah Cannon Research Institute UK	London	Greater London	United Kingdom	W1G 6AD
135	Nottingham University Hospitals NHS Trust	Nottingham	Nottinghamshire	United Kingdom	NG5 1PB
136	Royal Berkshire Hospital	London		United Kingdom	RG1 5AN
137	Guy's and St Thomas NHS Foundation Trust	London		United Kingdom	SE1 9RT
138	East and North Hertfordshire NHS Trust	Northwood		United Kingdom	HA6 2RN
139	Mount Vernon Hospital	Northwood		United Kingdom	HA6 2RN
140	Peterborough And Stamford Hospitals - Haematology & Oncology	Peterborough		United Kingdom	PE3 9GZ
141	Peterborough And Stamford Hospitals	Peterborough		United Kingdom	PE3 9GZ