Maintenance Treatment With BGB-290 Versus Placebo in Participants With Platinum-sensitive Recurrent Ovarian Cancer

A Phase 3 Randomized, Double-blind, Placebo-controlled, Multicenter Trial of Maintenance Treatment With BGB-290 Versus Placebo in Patients With Platinum-sensitive Recurrent Ovarian Cancer

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03519230

Enrollment

224

Registered

2018-05-08

Start date

2018-05-14

Completion date

2027-01-30

Last updated

2026-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ovarian Cancer

Brief summary

To evaluate the efficacy, safety and tolerability of maintenance therapy with BGB-290(Pamiparib) versus placebo in Chinese participants with recurrent ovarian cancer who achieved a complete response (CR) or partial response (PR) after platinum-based chemotherapy

Interventions

DRUGPamiparib capsule

60 mg twice daily (BID), orally (per os-PO)

DRUGPlacebo capsule

60mg BID, PO

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Key Inclusion Criteria: 1. Histologically diagnosed high-grade serous or endometrioid ovarian cancer (including primary peritoneal and fallopian tube cancer) 2. Completion of ≥2 previous platinum-containing regimens (eg, carboplatin or cisplatin) 3. Complete response (CR) or partial response (PR) achieved with last platinum-based chemotherapy regimen as determined by investigator per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 4. Ability to be randomized ≤8 weeks after last dose of platinum Key

Exclusion criteria

1. Prior treatment with a poly (ADP-ribose) polymerase (PARP) inhibitor 2. Progressive disease (PD) as per CA-125 criteria before randomization 3. Diagnosis of myelodysplastic syndrome (MDS) 4. Known history of intolerance to the excipients of the Pamiparib capsule NOTE: Other protocol defined Inclusion/

Design outcomes

Primary

Measure	Time frame
Progression free survival (PFS) by blinded Independent Review Committee (BIRC) assessment	up to 8 years

Secondary

Measure	Time frame
Overall survival	up to 9 years
Objective response rate by investigator assessment	up to 2 years
Duration of response by investigator assessment	up to 2 years
PFS by investigator assessment	up to 8 years
Time to response by investigator assessment	up to 8 years
Number of participants with treatment-emergent adverse events (TEAEs)	up to 9 years

Countries

China

Contacts

STUDY_DIRECTORStudy Director

BeiGene

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 17, 2026