Clinical trial NCT03427814: Study of BGB-290 or Placebo in Participants With Advanced or Inoperable Gastric Cancer
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Advanced or Inoperable Gastric Cancer
Keywords: BGB-290
PARP inhibitor
Phase 2
maintenance therapy
gastric cancer
oral treatment
PARALLEL 303
PARALLEL
BGB290303
BGB-290-303
Lead sponsor: BeiGene
Sponsor class: INDUSTRY
First posted: 2018-02-09
Enrollment: 136
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Progression Free Survival (PFS) by Investigator Assessment
timeFrame: Approximately 23 months
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: Approximately 23 months
measure: Time To Second Subsequent Treatment (TSST)
timeFrame: Approximately 23 months
measure: Objective Response Rate (ORR)
timeFrame: Approximately 23 months
measure: Duration of Response (DOR)
timeFrame: Approximately 23 months
measure: Time To Response
timeFrame: Approximately 23 months
measure: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
timeFrame: 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)
Other outcomes:
Locations:
city: Miami
country: United States
facility: Miami Cancer Institute
state: Florida
city: West Palm Beach
country: United States
facility: Scri Florida Cancer Specialist East
state: Florida
city: Goshen
country: United States
facility: Goshen Center For Cancer Care
state: Indiana
city: Wichita
country: United States
facility: Cancer Center of Kansas
state: Kansas
city: Louisville
country: United States
facility: Norton Cancer Institute
state: Kentucky
city: Charlotte
country: United States
facility: Novant Health Hematology Charlotte
state: North Carolina
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
city: Gosford
country: Australia
facility: Gosford Hospital
state: New South Wales
city: Clayton
country: Australia
facility: Monash Health
state: Victoria
city: Wendouree
country: Australia
facility: Ballarat Oncology and Haematology Services
state: Victoria
city: Subiaco
country: Australia
facility: St John of God Health Care
state: Western Australia
city: Brugge
country: Belgium
facility: Az Sint Jan Brugge
city: Leuven
country: Belgium
facility: University Hospitals Leuven
city: Hefei
country: China
facility: Anhui Provincial Hospital
state: Anhui
city: Beijing
country: China
facility: Beijing Cancer Hospital
state: Beijing
city: Guangzhou
country: China
facility: Sun Yat Sen University Cancer Center
state: Guangdong
city: Guangzhou
country: China
facility: Nanfang Hospital of Southern Medical University
state: Guangdong
city: Shantou
country: China
facility: Cancer Hospital of Shantou University Medical College
state: Guangdong
city: Nanjing
country: China
facility: Nanjing Drum Tower Hospital,the Affiliated Hospital of Nanjing University Medical School
state: Jiangsu
city: Shenyang
country: China
facility: Liaoning Cancer Hospital and Institute
state: Liaoning
city: Jinan
country: China
facility: Shandong Cancer Hospital
state: Shandong
city: Qingdao
country: China
facility: The Affiliated Hospital of Qingdao University Branch South
state: Shandong
city: Shanghai
country: China
facility: Affiliated Zhongshan Hospital of Fudan University
state: Shanghai
city: Praha
country: Czechia
facility: Fakultni Nemocnice Bulovka
city: Brest
country: France
facility: Chru de Brest Hospital Morvan
city: Doubs
country: France
facility: Chu Besancon Hopital Jean Minjoz
city: Lyon
country: France
facility: Hopital Prive Jean Mermoz
city: Montpellier
country: France
facility: Icm Val Daurelle Oncologie Medicale
city: Plerin
country: France
facility: Hopital Prive Des Cotes Darmor Service Oncologie
city: Rennes
country: France
facility: Centre Eugene Marquis
city: SaintHerblain
country: France
facility: Ico Site Rene Gauducheau
city: Toulouse
country: France
facility: Iuc Toulouse Oncopole
city: Villejuif
country: France
facility: Institut Gustave Roussy
city: Tbilisi
country: Georgia
facility: Acad Fridon Todua Medical Center Ltd Research Institute of Clinical Medicine Ltd
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital
city: Budapest
country: Hungary
facility: Orszagos Onkologiai Intezet
city: Pecs
country: Hungary
facility: Pecsi Tudomanyegyetem Klinikai Kozpont
city: Fukuokashi
country: Japan
facility: Nho Kyushu Cancer Center
state: Fukuoka
city: Ikoma
country: Japan
facility: Kindai University Nara Hospital
state: Nara
city: Yufushi
country: Japan
facility: Oita University Hospital
state: Oita
city: Osakasayama
country: Japan
facility: Kindai University Hospital
state: Osaka
city: Suitashi
country: Japan
facility: Osaka University Hospital
state: Osaka
city: Hidakashi
country: Japan
facility: Saitama Medical University International Medical Center
state: Saitama
city: Koto
country: Japan
facility: Showa University Koto Toyosu Hospital Oncology
state: Tokyo
city: Gdynia
country: Poland
facility: Szpitale Pomorskie Spolka Z Ograniczona Odpowiedzialnoscia
city: Lublin
country: Poland
facility: Centrum Onkologii Ziemi Lubelskiej
city: Warszawa
country: Poland
facility: Narodowy Instytut Onkologii Im Marii Skodowskiej Curie Pastwowy Instytut Badawczy
city: Wieliszew
country: Poland
facility: Mazowiecki Szpital Onkologiczny
city: Arkhangelsk
country: Russian Federation
facility: Arkhangelsk Regional Clinical Oncological Dispensary
state: Arkhangel'skaya Oblast'
city: Kursk
country: Russian Federation
facility: Regional Buz Kurskiy Regional Clinical Oncologic Dispensary
state: Kurskaya Oblast'
city: Omsk
country: Russian Federation
facility: Bih of Omsk Region Clinical Oncology Dispensary
state: Omskaya Oblast'
city: SaintPetersburg
country: Russian Federation
facility: Pavlov First Saint Petersburg State Medical University
state: Sankt-Peterburg
city: Volgograd
country: Russian Federation
facility: State Budgetary Healthcare Institution Volgograd Regional Clinical Oncology Dispensary
state: Volgogradskaya Oblast'
city: Singapore
country: Singapore
facility: Tan Tock Seng Hospital Oncology
city: Barcelona
country: Spain
facility: Hospital de La Santa Creu I Sant Pau
city: Barcelona
country: Spain
facility: Hospital Universitario Vall Dhebron
city: Barcelona
country: Spain
facility: Institut Catala Doncologia
city: Madrid
country: Spain
facility: Hospital Universitario Ramon Y Cajal
city: Madrid
country: Spain
facility: Hospital Universitario Hm Madrid Sanchinarro
city: Majadahonda
country: Spain
facility: Hospital Universitario Puerta de Hierro Majadahonda
city: Pamplona
country: Spain
facility: Clinica Universidad de Navarra Pamplona
city: Valencia
country: Spain
facility: Hospital Clinico Universitario de Valencia
city: Tainan
country: Taiwan
facility: Chi Mei Medical Center
city: London
country: United Kingdom
facility: Sarah Cannon Research Institute Uk
city: Wirral
country: United Kingdom
facility: Clatterbridge Cancer Centre
Study officials:
affiliation: BeiGene
name: Study Director
role: STUDY_DIRECTOR
References: