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Closed (no longer recruiting)Last updated: 1 February 2024

This phase III study is evaluating a drug (BGB-290) as maintenance therapy for the treatment of advanced or inoperable gastric cancer in patients who have previously been treated with platinum based chemotherapyA 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 summary

Summary

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 in subjects with advanced or inoperable gastric cancer.

Conditions

This trial is treating patients with advanced or inoperable gastric cancer.

Cancer

Upper gastrointestinal tract Cancers Upper gastrointestinal tract

Age

People18+

Phase

III

More information

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Trial sponsor

BeiGene Australia Pty Ltd

Scientific 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

Eligibility

Inclusion

  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. Eastern Cooperative Oncology Group (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

  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)
  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.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Inclusion

  • You are able to swallow medication by mouth.
  • You have had a certain type of treatment or surgical procedure.
  • Your cancer has spread to other parts of the body.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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