A Phase 2 interventional study of Pamiparib and Placebo in Advanced or Inoperable Gastric Cancer, sponsored by BeiGene. Completed at 65 sites in 16 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-10-26.
Sponsored by BeiGene · Phase 2, Interventional, and Treatment
This study enrolled 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 received BGB-290; in Arm B participants received placebo. The purpose of this study is to show that BGB-290 (pamiparib) (versus placebo) will improve progression-free survival (PFS) in participants with advanced or inoperable gastric cancer.
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.
Key Inclusion Criteria:
Key Exclusion Criteria:
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Participants received pamiparib orally.
Drug: Pamiparib
Participants received placebo orally.
Drug: Placebo
60 mg orally twice daily
Also known as: BGB-290
60 mg orally twice daily
Progression Free Survival (PFS) by Investigator Assessment
PFS is defined as the time from randomization to progressive disease (PD) per Response Evaluation Criteria in Solid Tumors ( RECIST) Version 1.1 by investigator assessment or death due to any cause, whichever occurs first.
Time frame: Approximately 23 months
Overall Survival (OS)
OS is defined as the time from randomization to death due to any cause.
Time frame: Approximately 23 months
Time To Second Subsequent Treatment (TSST)
TSST is defined as the time from randomization until the second subsequent anticancer therapy or death after next-line therapy
Time frame: Approximately 23 months
Objective Response Rate (ORR)
ORR is defined as the percentage of participants with a best overall response of Complete Response or Partial Response per RECIST Version 1.1 by investigator assessment
Time frame: Approximately 23 months
Duration of Response (DOR)
DOR is defined as the time from the first documented confirmed response of Complete Response or Partial Response to progressive disease (PD) per RECIST Version 1.1 by investigator assessment or death due to any cause, whichever occurs first
Time frame: Approximately 23 months
Time To Response
Time to response is defined as the time from randomization to the first documented response of Complete Response or Partial Response per RECIST Version 1.1 by investigator assessment
Time frame: Approximately 23 months
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Time frame: From start of study treatment until 30 days after the last study drug intake or initiation of new anticancer therapy, whichever occurs first (up to approximately 4 years and 5.5 months)
Participants were enrolled in multiple study centers in Asia, Australia, Europe, and North America.
| Milestone | Pamiparib | Placebo |
|---|---|---|
| Started | 71 | 65 |
| Completed | 0 | 0 |
| Not completed | 71 | 65 |
| Withdrew: Withdrawal by subject | 4 | 4 |
| Withdrew: Lost to follow-up | 0 | 2 |
| Withdrew: Death | 42 | 31 |
| Withdrew: Sponsor's decision | 1 | 0 |
| Withdrew: Investigator's decision | 1 | 2 |
| Withdrew: Disease progression | 1 | 0 |
| Withdrew: Treatment completed | 0 | 1 |
| Withdrew: Sponsor's decision to end study | 21 | 25 |
| Withdrew: Transfer to long term extension study | 1 | 0 |
PFS is defined as the time from randomization to progressive disease (PD) per Response Evaluation Criteria in Solid Tumors ( RECIST) Version 1.1 by investigator assessment or death due to any cause, whichever occurs first.
| Months | Pamiparib | Placebo |
|---|---|---|
| Progression Free Survival (PFS) by Investigator Assessment | 3.7 (1.94 to 5.26) | 2.1 (1.87 to 3.75) |
OS is defined as the time from randomization to death due to any cause.
| Months | Pamiparib | Placebo |
|---|---|---|
| Overall Survival (OS) | 10.2 (8.71 to 16.33) | 12.0 (8.21 to NA) |
TSST is defined as the time from randomization until the second subsequent anticancer therapy or death after next-line therapy
| Months | Pamiparib | Placebo |
|---|---|---|
| Time To Second Subsequent Treatment (TSST) | 9.8 (8.05 to 10.94) | 9.7 (7.49 to 14.00) |
ORR is defined as the percentage of participants with a best overall response of Complete Response or Partial Response per RECIST Version 1.1 by investigator assessment
| Percentage of participants | Pamiparib | Placebo |
|---|---|---|
| Objective Response Rate (ORR) | 7.7 (1.62 to 20.87) | 6.3 (0.77 to 20.81) |
DOR is defined as the time from the first documented confirmed response of Complete Response or Partial Response to progressive disease (PD) per RECIST Version 1.1 by investigator assessment or death due to any cause, whichever occurs first
| Months | Pamiparib | Placebo |
|---|---|---|
| Duration of Response (DOR) | 3.6 (3.48 to NA) | NA (5.55 to NA) |
Time to response is defined as the time from randomization to the first documented response of Complete Response or Partial Response per RECIST Version 1.1 by investigator assessment
| Months | Pamiparib | Placebo |
|---|---|---|
| Time To Response | 3.68 (1.8 to 7.3) | 1.87 (1.87 to 1.9) |
| Number of participants | Pamiparib | Placebo |
|---|---|---|
| Participants With At Least 1 TEAE | 66 | 61 |
| Participants with Serious TEAEs | 17 | 11 |
Collected over From start of study treatment until 30 days after the last study drug intake or initiation of new anticancer therapy, whichever occurs first (up to approximately 4 years and 5.5 months). Non-serious events are listed at a 3% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Pamiparib | 42/71 (59.2%) | 17/71 (23.9%) | 65/71 (91.5%) |
| Placebo | 31/65 (47.7%) | 11/65 (16.9%) | 57/65 (87.7%) |
| Event | Pamiparib | Placebo |
|---|---|---|
| DysphagiaGastrointestinal disorders | 0/71 | 3/65 |
| AnaemiaBlood and lymphatic system disorders | 3/71 | 1/65 |
| Obstruction gastricGastrointestinal disorders | 0/71 | 2/65 |
| VomitingGastrointestinal disorders | 2/71 | 0/65 |
| DeathGeneral disorders | 2/71 | 0/65 |
| PneumoniaInfections and infestations | 2/71 | 1/65 |
| Gastrointestinal haemorrhageGastrointestinal disorders | 0/71 | 1/65 |
| Malignant dysphagiaGastrointestinal disorders | 0/71 | 1/65 |
| Upper gastrointestinal haemorrhageGastrointestinal disorders | 1/71 | 1/65 |
| SepsisInfections and infestations | 0/71 | 1/65 |
| Event | Pamiparib | Placebo |
|---|---|---|
| AnaemiaBlood and lymphatic system disorders | 25/71 | 10/65 |
| NauseaGastrointestinal disorders | 23/71 | 12/65 |
| Decreased appetiteMetabolism and nutrition disorders | 19/71 | 9/65 |
| VomitingGastrointestinal disorders | 16/71 | 2/65 |
| AstheniaGeneral disorders | 16/71 | 12/65 |
| Abdominal painGastrointestinal disorders | 9/71 | 13/65 |
| DiarrhoeaGastrointestinal disorders | 13/71 | 9/65 |
| Abdominal pain upperGastrointestinal disorders | 12/71 | 7/65 |
| ConstipationGastrointestinal disorders | 9/71 | 9/65 |
| Peripheral sensory neuropathyNervous system disorders | 4/71 | 9/65 |
Intent to Treat (ITT) Analysis Set included all randomized participants who were assigned to a study drug (pamiparib or placebo)
| Age, Continuous(years) | Pamiparib | Placebo | Total |
|---|---|---|---|
| Mean | 62.5 ± 9.82 | 62.1 ± 11.23 | 62.3 ± 10.48 |
| Sex: Female, Male(Participants) | Pamiparib | Placebo | Total |
|---|---|---|---|
| Female | 25 | 20 | 45 |
| Male | 46 | 45 | 91 |
| Ethnicity (NIH/OMB)(Participants) | Pamiparib | Placebo | Total |
|---|---|---|---|
| Hispanic or Latino | 4 | 5 | 9 |
| Not Hispanic or Latino | 53 | 50 | 103 |
| Unknown or Not Reported | 14 | 10 | 24 |
| Race/Ethnicity, Customized(Participants) | Pamiparib | Placebo | Total |
|---|---|---|---|
| Asian | 20 | 15 | 35 |
| Black or African America | 0 | 2 | 2 |
| Native Hawaiian or Other Pacific Islander | 0 | 1 | 1 |
| White | 38 | 36 | 74 |
| Other | 1 | 3 | 4 |
| Not Reported/Unknown | 12 | 8 | 20 |
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