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

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ClinicalTrials.gov Identifier: NCT03427814
Recruitment Status : Recruiting
First Posted : February 9, 2018
Last Update Posted : September 12, 2019
Sponsor:
Information provided by (Responsible Party):
BeiGene

Brief 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 (PFS) in subjects with advanced or inoperable gastric cancer.

Condition or disease Intervention/treatment Phase
Advanced or Inoperable Gastric Cancer Drug: BGB-290 Drug: Placebo Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 540 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: PARALLEL 303: 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
Actual Study Start Date : July 23, 2018
Estimated Primary Completion Date : June 1, 2020
Estimated Study Completion Date : September 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer

Arm Intervention/treatment
Experimental: Arm A
Approximately 270 subjects to receive BGB-290 orally.
Drug: BGB-290
60 mg PO BID
Other Name: pamiparib

Placebo Comparator: Arm B
Approximately 270 subjects to receive placebo orally.
Drug: Placebo
60 mg PO BID




Primary Outcome Measures :
  1. 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 blinded independent central review.


Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. 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 ]
  5. Objective response rate by investigator assessment [ Time Frame: From randomization to first documentation of disease progression assessed up to 5 years ]
  6. 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 ]
  7. 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 ]
  8. Incidence, nature and severity of adverse events between treatment groups [ Time Frame: From time of randomization to approximately 30 days after end of treatment ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03427814


Contacts
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Contact: Jeannie Hou, Senior Director 1 (877) 828-5568 clinicaltrials@beigene.com

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Sponsors and Collaborators
BeiGene

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Responsible Party: BeiGene
ClinicalTrials.gov Identifier: NCT03427814     History of Changes
Other Study ID Numbers: BGB-290-303
2017-003493-13 ( EudraCT Number )
CTR20171664 ( Registry Identifier: Center for drug evaluation, CFDA )
First Posted: February 9, 2018    Key Record Dates
Last Update Posted: September 12, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by BeiGene:
BGB-290
PARP inhibitor
Phase 3
maintenance therapy
gastric cancer
oral treatment
PARALLEL303
PARALLEL 303
PARALLEL
BGB290303
BGB-290-303
Additional relevant MeSH terms:
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Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases