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Trial record 1 of 1 for:    NCT03427814
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Study of BGB-290 or Placebo in Participants With Advanced or Inoperable Gastric Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03427814
Recruitment Status : Active, not recruiting
First Posted : February 9, 2018
Last Update Posted : September 16, 2020
Sponsor:
Information provided by (Responsible Party):
BeiGene

Tracking Information
First Submitted Date  ICMJE February 5, 2018
First Posted Date  ICMJE February 9, 2018
Last Update Posted Date September 16, 2020
Actual Study Start Date  ICMJE July 23, 2018
Estimated Primary Completion Date November 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 8, 2018)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 18, 2020)
  • 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 2.5 years ]
  • 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 2.5 years ]
  • 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 2.5 years ]
  • 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 2.5 years ]
  • Objective response rate by investigator assessment [ Time Frame: From randomization to first documentation of disease progression assessed up to 2.5 years ]
  • 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 2.5 years ]
  • 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 2.5 years ]
  • Incidence, nature and severity of adverse events between treatment groups [ Time Frame: From time of randomization to approximately 30 days after end of treatment ]
Original Secondary Outcome Measures  ICMJE
 (submitted: February 8, 2018)
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • Objective response rate by investigator assessment [ Time Frame: From randomization to first documentation of disease progression assessed up to 5 years ]
  • 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 ]
  • 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 ]
  • Incidence, nature and severity of adverse events between treatment groups [ Time Frame: From time of randomization to approximately 30 days after end of treatment ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of BGB-290 or Placebo in Participants With Advanced or Inoperable Gastric Cancer
Official Title  ICMJE PARALLEL 303: A Phase 2, 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
Brief Summary This study will enroll 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 will receive BGB-290; in Arm B participants will receive placebo. The purpose of this study is to show that BGB-290 (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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Advanced or Inoperable Gastric Cancer
Intervention  ICMJE
  • Drug: pamiparib
    60 mg PO BID
    Other Name: BGB-290
  • Drug: Placebo
    60 mg PO BID
Study Arms  ICMJE
  • Experimental: Pamiparib
    Approximately 270 participants to receive pamiparib orally.
    Intervention: Drug: pamiparib
  • Placebo Comparator: Placebo
    Approximately 270 participants to receive placebo orally.
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: May 18, 2020)
128
Original Estimated Enrollment  ICMJE
 (submitted: February 8, 2018)
540
Estimated Study Completion Date  ICMJE April 1, 2021
Estimated Primary Completion Date November 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Key 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.

Key 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.

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Belgium,   China,   Czechia,   France,   Georgia,   Hong Kong,   Hungary,   Japan,   Poland,   Romania,   Russian Federation,   Singapore,   Spain,   Taiwan,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03427814
Other Study ID Numbers  ICMJE BGB-290-303
2017-003493-13 ( EudraCT Number )
CTR20171664 ( Registry Identifier: Center for drug evaluation, CFDA )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Responsible Party BeiGene
Study Sponsor  ICMJE BeiGene
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Maggie Zhang, PharmD BeiGene
PRS Account BeiGene
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP