Inoperable Locally Advanced or Metastatic Gastric Cancer
Conditions
Interventions
investigational material(s)
Generic name etc : pamiparib
INN of investigational material : pamiparib
Therapeutic category code : 429 Other antitumor agents
Dosage and Administration for Investigationa
Sponsors
Beigene ( ICCC: Parexel International)
Eligibility
Sex/Gender
All
Inclusion criteria
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 = 4 weeks or complete response (CR). 6.Able to be randomized to study <=8 weeks after last platinum dose. 7.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.
Exclusion criteria
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) or active bleeding disorder. 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy Progression free survival [ Time Frame: 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 Investigator. | — |
Secondary
| Measure | Time frame |
|---|---|
| safety efficacy -Overall survival between treatment groups (BGB-290 versus placebo) [ Time Frame: From time of randomization until date of death due to any cause assessed, up to 5 years] -Time to second subsequent treatment [ Time time from randomization until the second subsequent anti-cancer therapy or death after next-line therapy, up to 5 years ] by inv Frame: From theestigator assessment -Objective response rate by investigator assessment [ Time Frame: From randomization to first documentation of disease progression assessed up to 5 years ] -Duration of response by investigator assessment [ Time Frame: 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 5 years ] -Time to response by investigator assessment [ Time Frame: Defined as the time from randomization to the first documented confirmed response of CR or PR assessed up to 5 years ] -Incidence, nature and severity of adverse events between treatment groups [ Time Frame: From time of randomization to approximately 30 days after end of treatment ] | — |
Countries
Asia except Japan, Europe, Japan, North America, Oceania
Outcome results
None listed