Inoperable Locally Advanced or Metastatic Gastric Cancer that Responded to Platinum-based First-line Chemotherapy MedDRA version: 20.0 Level: PT Classification code 10063916 Term: Metastatic gastric cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Code: BGB-290
Pharmaceutical Form: Capsule
INN or Proposed INN: BGB-290
Current Sponsor code: BGB-290
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 20-
Ph
Sponsors
BeiGene Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients must meet all of the following criteria to be eligible for the study: 1) Age 18 years 2) Histologically proven adenocarcinoma of the stomach or gastroesophageal junction, inoperable locally advanced or with metastatic disease a) Patients with gastric cancer overexpressing HER2 are not allowed. b) Irradiation as part of prior first-line treatment is not allowed. 3) Availability of archival tumor tissue for central laboratory determination of HRD status for randomization and exploratory biomarker analyses 4) Confirmed PR that is maintained for >=4 weeks or CR as determined by the investigator per RECIST Version 1.1 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 200 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 340
Exclusion criteria
Exclusion criteria: 1) Unresolved acute effects of prior therapy of Grade =2 2) Prior treatment with a PARP inhibitor 3) Chemotherapy, biologic therapy, immunotherapy, investigational agent, anticancer Chinese medicine, or anticancer herbal remedies =14 days prior to randomization 4) Diagnosis of MDS 5) Leptomeningeal disease or brain metastasis 6) Previous complete gastric resection, chronic diarrhea, active inflammatory gastrointestinal disease, or any other disease causing malabsorption syndrome 7) Active bleeding disorder
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of maintenance therapy with BGB-290 versus placebo in patients with inoperable locally advanced or metastatic gastric cancer with a complete response (CR) or confirmed partial response (PR) after first-line platinum-based chemotherapy, as measured by: Progression-free survival (PFS) by Blinded Independent Review Committee (BIRC) assessment.;Secondary Objective: To further evaluate the efficacy of maintenance therapy with BGB-290 versus placebo in patients with inoperable locally advanced or metastatic gastric cancer with a CR or confirmed PR after first-line platinum-based chemotherapy, as measured by: * Overall survival (OS) * PFS by investigator assessment * Progression-free survival 2 (PFS2) by investigator assessment * Time to second subsequent treatment (TSST) by investigator assessment * Objective response rate (ORR; CR or PR) by investigator assessment * Duration of response by investigator assessment * Time to response by investigator assessment To evaluate safety and tolerability of BGB-290 versus placebo, as measured by: * Incidence, timing, and severity of treatment-emergent adverse events (TEAEs), graded according to National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 4.03 or higher;Primary end point(s): Progression-free survival (PFS) assessed by Blinded Independent Review Committee (BIRC);Timepoint(s) of evaluation of this end point: For PFS, there will be 1 planned interim analysis. The interim analysis will be performed when 242 PFS events (66.7% of the final target number of PFS events) have occurred at approximately 23 months after start of randomization, and the final analysis will be performed when 363 PFS events have occurred at approximately 29 months after start of randomization. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Overall survival (OS);Timepoint(s) of evaluation of this end point: There will be 1 interim analysis of OS at the final of PFS analysis. The interim analysis will be performed at the final PFS analysis with positive PFS results and expected 285 deaths. The final analysis will be performed when 390 deaths have occurred. | — |
Countries
Australia, Belgium, China, France, Germany, Hong Kong, Hungary, Italy, Japan, Poland, Russian Federation, Singapore, Spain, Taiwan, United Kingdom, United States
Contacts
Public ContactClinical Trial Information Email
BeiGene Ltd.
Outcome results
None listed