Study of BGB-290 or Placebo in Participants With Advanced or Inoperable Gastric Cancer

Phase 2

Completed

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.

Recruitment & Eligibility

Inclusion Criteria

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 Criteria

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.

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Participants received placebo orally.
Pamiparib	Pamiparib	Participants received pamiparib orally.

Primary Outcome Measures

Name	Time	Method
Progression Free Survival (PFS) by Investigator Assessment	Approximately 23 months	PFS is defined as the time from randomization to progressive disease (PD) per Response Evaluation Criteria in Solid Tumors ( RECIST) Version 1.1 by investigator assessment or death due to any cause, whichever occurs first.

Secondary Outcome Measures

Name	Time	Method
Duration of Response (DOR)	Approximately 23 months	DOR is defined as the time from the first documented confirmed response of Complete Response or Partial Response to progressive disease (PD) per RECIST Version 1.1 by investigator assessment or death due to any cause, whichever occurs first
Time To Response	Approximately 23 months	Time to response is defined as the time from randomization to the first documented response of Complete Response or Partial Response per RECIST Version 1.1 by investigator assessment
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)	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)
Overall Survival (OS)	Approximately 23 months	OS is defined as the time from randomization to death due to any cause.
Time To Second Subsequent Treatment (TSST)	Approximately 23 months	TSST is defined as the time from randomization until the second subsequent anticancer therapy or death after next-line therapy
Objective Response Rate (ORR)	Approximately 23 months	ORR is defined as the percentage of participants with a best overall response of Complete Response or Partial Response per RECIST Version 1.1 by investigator assessment

Locations (65): Miami Cancer Institute
🇺🇸
Miami, Florida, United States
Scri Florida Cancer Specialist East
🇺🇸
West Palm Beach, Florida, United States
Goshen Center For Cancer Care
🇺🇸
Goshen, Indiana, United States
Novant Health Hematology Charlotte
🇺🇸
Charlotte, North Carolina, United States
Oregon Health and Science University
🇺🇸
Portland, Oregon, United States
Gosford Hospital
🇦🇺
Gosford, New South Wales, Australia
St John of God Health Care
🇦🇺
Subiaco, Western Australia, Australia
Az Sint Jan Brugge
🇧🇪
Brugge, Belgium
Anhui Provincial Hospital
🇨🇳
Hefei, Anhui, China
Beijing Cancer Hospital
🇨🇳
Beijing, Beijing, China
Scroll for more (55 remaining)
Miami Cancer Institute
🇺🇸Miami, Florida, United States