Clinical Trials /

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

NCT03427814

Description:

This study will enroll subjects with previously-treated advanced or inoperable gastric cancer who have responded to first line platinum therapy into two treatment arms. In Arm A subjects will receive BGB-290; in Arm B subjects will receive placebo. The purpose of this study is to show that BGB-290 (versus placebo) will improve progression-free survival (PFS) in subjects with advanced or inoperable gastric cancer.

Related Conditions:
  • Gastric Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 3

Trial Eligibility

Document

Title

  • Brief Title: Study of BGB-290 or Placebo in Patients With Advanced or Inoperable Gastric Cancer
  • Official Title: A Phase 3, Double-blind, Randomized Study of BGB-290 Versus Placebo as Maintenance Therapy in Patients With Inoperable Locally Advanced or Metastatic Gastric Cancer That Responded to Platinum-based First-line Chemotherapy

Clinical Trial IDs

  • ORG STUDY ID: BGB-290-303
  • SECONDARY ID: 2017-003493-13
  • NCT ID: NCT03427814

Conditions

  • Advanced or Inoperable Gastric Cancer

Interventions

DrugSynonymsArms
BGB-290pamiparibArm A
PlaceboArm B

Purpose

This study will enroll subjects with previously-treated advanced or inoperable gastric cancer who have responded to first line platinum therapy into two treatment arms. In Arm A subjects will receive BGB-290; in Arm B subjects will receive placebo. The purpose of this study is to show that BGB-290 (versus placebo) will improve progression-free survival (PFS) in subjects with advanced or inoperable gastric cancer.

Detailed Description

      This is a double-blind, placebo controlled, randomized multicenter global phase 3 study
      comparing the efficacy and safety of single agent poly (ADP-ribose) polymerase (PARP)
      inhibitor BGB-290 to placebo as maintenance therapy in subjects with advanced gastric cancer
      who have responded to first line platinum based chemotherapy. Subjects 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.

      Patients 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 patients without disease progression, survival status, and new anticancer therapy.
    

Trial Arms

NameTypeDescriptionInterventions
Arm AExperimentalApproximately 270 subjects to receive BGB-290 orally.
  • BGB-290
Arm BPlacebo ComparatorApproximately 270 subjects to receive placebo orally.
  • Placebo

Eligibility 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 ≤ 28 weeks.

          5. Confirmed partial response (PR) maintained 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:

          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.
      
Maximum Eligible Age:99 Years
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure: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
Safety Issue:
Description:The primary objective of this study is to compare progression free survival between treatment groups (BGB-290 versus placebo) as determined by blinded independent central review.

Secondary Outcome Measures

Measure: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
Safety Issue:
Description:
Measure:Progression free survival between treatment groups determined by investigator assessment
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
Safety Issue:
Description:
Measure:Progression free survival on subsequent treatment (PFS2)
Time Frame:From the time of randomization to second disease progression, or death from any cause, whichever is first, up to 5 years
Safety Issue:
Description:
Measure:Time to second subsequent treatment
Time Frame:From the time from randomization until the second subsequent anti-cancer therapy or death after next-line therapy, up to 5 years
Safety Issue:
Description:
Measure:Objective response rate by investigator assessment
Time Frame:From randomization to first documentation of disease progression assessed up to 5 years
Safety Issue:
Description:
Measure: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
Safety Issue:
Description:
Measure: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
Safety Issue:
Description:
Measure:Incidence, nature and severity of adverse events between treatment groups
Time Frame:From time of randomization to approximately 30 days after end of treatment
Safety Issue:
Description:

Details

Phase:Phase 3
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:BeiGene

Trial Keywords

  • BGB-290
  • PARP inhibitor
  • Phase 3
  • maintenance therapy
  • gastric cancer
  • oral treatment

Last Updated

February 8, 2018