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 : November 4, 2019
|Condition or disease||Intervention/treatment||Phase|
|Advanced or Inoperable Gastric Cancer||Drug: BGB-290 Drug: Placebo||Phase 3|
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.
|Study Type :||Interventional|
|Estimated Enrollment :||540 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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|
Experimental: Arm A
Approximately 270 subjects to receive BGB-290 orally.
60 mg PO BID
Other Name: pamiparib
Placebo Comparator: Arm B
Approximately 270 subjects to receive placebo orally.
60 mg PO BID
- 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.
- 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 ]
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
|Contact: BeiGene||1 (877) email@example.com|
|Study Director:||Heinrich Farin, MD||BeiGene|