Status:
COMPLETED
Study of BGB-290 or Placebo in Participants With Advanced or Inoperable Gastric Cancer
Lead Sponsor:
BeiGene
Conditions:
Advanced or Inoperable Gastric Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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...
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 place...
Eligibility Criteria
Inclusion
- Key
- 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.
- Eastern Cooperative Oncology Group (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
- 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)
- 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.
Key Trial Info
Start Date :
July 3 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 3 2023
Estimated Enrollment :
136 Patients enrolled
Trial Details
Trial ID
NCT03427814
Start Date
July 3 2018
End Date
January 3 2023
Last Update
October 26 2024
Active Locations (65)
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1
Miami Cancer Institute
Miami, Florida, United States, 33176
2
Scri Florida Cancer Specialist East
West Palm Beach, Florida, United States, 33401
3
Goshen Center For Cancer Care
Goshen, Indiana, United States, 46526
4
Cancer Center of Kansas
Wichita, Kansas, United States, 67214