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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

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
ChiCTR
Registry ID
ChiCTR1800014643
Enrollment
Unknown
Registered
2018-02-05
Start date
2018-03-01
Completion date
Unknown
Last updated
2018-02-12

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

Conditions

Platinum-sensitive Recurrent Ovarian Cancer

Interventions

Treatment group/Placebo group:BGB-290/placebo

Sponsors

BeiGene (Beijing) Co., Ltd.
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to No maximum

Inclusion criteria

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; 4. Ability to be randomized =8 weeks after last dose of platinum.

Exclusion criteria

Exclusion criteria: 1. Prior treatment with a poly (ADP-ribose) polymerase (PARP) inhibitor; 2. Diagnosis of myelodysplastic syndrome (MDS); 3. Known history of intolerance to the excipients of the BGB-290 capsule.

Design outcomes

Primary

MeasureTime frame
Progression-free survival (PFS);

Secondary

MeasureTime frame
Overall survival (OS);Objective response rate (ORR; CR or PR);Safety and tolerability;

Countries

China

Contacts

Public ContactPing Liu

BeiGene (Shanghai) Co., Ltd.

ping.liu@beigene.com+86 15026763424

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026