Description:
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.
Title
- Brief Title: Study of BGB-290 or Placebo in Participants With Advanced or Inoperable Gastric Cancer
- Official Title: 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
Clinical Trial IDs
- ORG STUDY ID:
BGB-290-303
- SECONDARY ID:
2017-003493-13
- SECONDARY ID:
CTR20171664
- NCT ID:
NCT03427814
Conditions
- Advanced or Inoperable Gastric Cancer
Interventions
Drug | Synonyms | Arms |
---|
pamiparib | BGB-290 | Pamiparib |
Placebo | | Placebo |
Purpose
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.
Trial Arms
Name | Type | Description | Interventions |
---|
Pamiparib | Experimental | Approximately 64 participants to receive pamiparib orally. | |
Placebo | Placebo Comparator | Approximately 64 participants to receive placebo orally. | |
Eligibility Criteria
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.
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 2.5 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 2.5 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 2.5 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 2.5 years |
Safety Issue: | |
Description: | |
Measure: | Objective response rate by investigator assessment |
Time Frame: | From randomization to first documentation of disease progression assessed up to 2.5 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 2.5 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 2.5 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 2 |
Primary Purpose: | Interventional |
Overall Status: | Active, not recruiting |
Lead Sponsor: | BeiGene |
Trial Keywords
- BGB-290
- PARP inhibitor
- Phase 2
- maintenance therapy
- gastric cancer
- oral treatment
- PARALLEL303
- PARALLEL 303
- PARALLEL
- BGB290303
- BGB-290-303
Last Updated
July 9, 2021