Inoperable Locally Advanced or Metastatic Gastric Cancer that Responded to Platinum-based First-line Chemotherapy MedDRA version: 21.1 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: pamiparib
Current Sponsor code: BGB-290
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 20-
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 48 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 80
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 investigator 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) * 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 ;Primary end point(s): Progression-free survival (PFS) assessed by investigator assessment;Timepoint(s) of evaluation of this end point: This study is designed to provide 80% power for PFS. The following assumptions are used in determining the sample size for this study: - Overall type I error rate: 0.1 (1-sided) - Randomization: 1:1 - Median PFS for placebo group: 6.0 months - PFS HR (BGB-290/placebo): 0.63 A sample size of approximately 128 patients (64 per treatment group) is required to achieve 85 PFS events within the planned study duration of approximately 26 months after the first patient is randomized to study, assuming an estimated accrual period of 20 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Overall survival (OS);Timepoint(s) of evaluation of this end point: A sample size of approximately 128 patients (64 per treatment group) is required to achieve 85 PFS events within the planned study duration of approximately 26 months after the first patient is randomized to study, assuming an estimated accrual period of 20 months. | — |
Countries
Australia, Belgium, China, Czech Republic, 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