Maintenance Treatment With BGB-290 Versus Placebo in Part... | NCT03519230

ID	Type	Description	Link
ChiCTR1800014643	Registry Identifier	Chinese Clinical Trial Registry
CTR20171666	Registry Identifier	ChinaDrugTrials

Status Module

Record Verification Date

Mar 2026

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 14, 2018Actual

Primary Completion Date

Dec 1, 2025Actual

Completion Date

Jan 30, 2027Estimated

First Submitted Date

Apr 26, 2018

First Submission Date that Met QC Criteria

Apr 26, 2018

First Posted Date

May 8, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 13, 2026

Last Update Posted Date

Mar 16, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

224Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Treatment arm	Experimental		Drug: Pamiparib capsule
Placebo arm	Placebo Comparator		Drug: Placebo capsule

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Pamiparib capsule	Drug	60 mg twice daily (BID), orally (per os-PO)	Treatment arm

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Overall survival		up to 9 years
Objective response rate by investigator assessment		up to 2 years
Duration of response by investigator assessment

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Key Inclusion Criteria:

Histologically diagnosed high-grade serous or endometrioid ovarian cancer (including primary peritoneal and fallopian tube cancer)
Completion of ≥2 previous platinum-containing regimens (eg, carboplatin or cisplatin)
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
Ability to be randomized ≤8 weeks after last dose of platinum

Key Exclusion Criteria:

Prior treatment with a poly (ADP-ribose) polymerase (PARP) inhibitor
Progressive disease (PD) as per CA-125 criteria before randomization
Diagnosis of myelodysplastic syndrome (MDS)
Known history of intolerance to the excipients of the Pamiparib capsule

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Study Director	BeiGene	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Anhui Provincial Cancer Hospital Aka West Branch of Anhui Province Hospital		Hefei	Anhui	230088	China

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

BeiGene shares data on completed studies responsibly and provides qualified scientific and medical researchers access to data and supporting documentation for clinical trials in dossiers for medicines and indications after submission and approval in the United States, China, and Europe. Clinical trials supporting subsequent local approvals, new indications, or combination products are eligible for sharing once corresponding regulatory approvals are achieved.

BeiGene shares data only when permitted by applicable data privacy and security laws and regulations, when it is feasible to do so without compromising the privacy of study participants, and other considerations.

Qualified researchers with appropriate competencies who are engaged in novel scientific research may submit a request for participant-level data with a research proposal for BeiGene review. Research teams must include a biostatistician and sign a Data Sharing Agreement prior to receiving access to clinical trial data.

Types

Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)

Time Frame

See plan description

Access Criteria

See plan description

URL

https://beigene.com/science/clinical-trials/

ID	Term
D010051	Ovarian Neoplasms

Ancestor Terms

ID	Term
D004701	Endocrine Gland Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D010049	Ovarian Diseases
D000291	Adnexal Diseases
D005831	Genital Diseases, Female
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D005833	Genital Neoplasms, Female
D014565	Urogenital Neoplasms
D000091662	Genital Diseases
D004700	Endocrine System Diseases
D006058	Gonadal Disorders