Ovarian CancerPhase 3NCT03519230
Maintenance Treatment With BGB-290 Versus Placebo in Participants With Platinum-sensitive Recurrent Ovarian Cancer
A Phase 3 study testing Pamiparib capsule in people with Ovarian Cancer, run by BeiGene at 28 sites in China.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer
- What is being tested?
- Pamiparib capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 224 participants
- Where
- 28 sitesChina
- Study dates
- 14 May 2018to 30 Jan 2027
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
28 sites in 1 country.
28 sites in 1 country
China28 sites
Peking University First Hospital
Beijing, Beijing Municipality, 100034
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
Jilin Cancer Hospital
Changchun, Jilin, 130021
The First Hospital of Jilin University
Changchun, Jilin, 130021
Hunan Cancer Hospital
Changsha, Hunan, 410013
West China Second University Hospital
Chengdu, Sichuan, 610101
Chongqing Cancer Hospital
Chongqing, Chongqing Municipality, 400030
Southwest Hospital
Chongqing, Chongqing Municipality, 400038
The Second Hospital of Dalian Medical University
Dalian, Liaoning, 116023
Sun Yat Sen Memorial Hospital, Sun Yat Sen University (North)
Guangzhou, Guangdong, 510000
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510120
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, 150000
Anhui Provincial Cancer Hospital Aka West Branch of Anhui Province Hospital
Hefei, Anhui, 230088
Qilu Hospital of Shandong University
Jinan, Shandong, 250000
Jiangxi Maternal and Child Health Hospital
Nanchang, Jiangxi, 330006
The Tumor Hospital Affiliated to Guangxi Medical University
Nanning, Guangxi, 530021
Obstetrics and Gynecology Hospital of Fudan University
Shanghai, Shanghai Municipality, 200011
Cancer Hospital of Shantou University Medical College
Shantou, Guangdong, 515031
Liaoning Cancer Hospital and Institute
Shenyang, Liaoning, 110042
Tianjin Central Hospital of Gynecology Obstetrics
Tianjin, Tianjin Municipality, 300052
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, 300060
Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430022
Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, 430030
Hubei Cancer Hospital
Wuhan, Hubei, 430079
Yantai Yuhuangding Hospital
Yantai, Shandong, 264000
Henan Cancer Hospital
Zhengzhou, Henan, 450000
About this study
Official title: 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
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
- Conditions
- Ovarian Cancer
- Being tested
- Pamiparib capsule, Placebo capsule
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pamiparib capsuleDrug
Also called BGB-290
60 mg twice daily (BID), orally (per os-PO)
Placebo capsuleDrug
60mg BID, PO
| Study group | Role | What they receive |
|---|---|---|
| Treatment arm | Experimental | Not described Receives: Drug: Pamiparib capsule |
| Placebo arm | Placebo comparator | Not described Receives: Drug: Placebo capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival (PFS) by blinded Independent Review Committee (BIRC) assessment
Measured: up to 8 years
Secondary outcomes (6)
Overall survival
Measured: up to 9 years
Objective response rate by investigator assessment
Measured: up to 2 years
Duration of response by investigator assessment
Measured: up to 2 years
PFS by investigator assessment
Measured: up to 8 years
Time to response by investigator assessment
Measured: up to 8 years
Number of participants with treatment-emergent adverse events (TEAEs)
Measured: up to 9 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2018
- Study start14 May 2018
- Primary completion1 Dec 2025
- Study completion30 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- More trials run by BeiGeneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 224 participants (actual)
Sponsor and investigators
- Lead sponsor
- BeiGene
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, BeiGene
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03519230
- Sponsor's protocol ID
- BGB-290-302
- Other IDs
- ChiCTR1800014643, CTR20171666
- Status last verified
- Mar 2026
- First submitted
- 26 Apr 2018
- Last updated
- 16 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.