Clinical trial NCT03519230: Maintenance Treatment With BGB-290 Versus Placebo in Participants With Platinum-sensitive Recurrent Ovarian Cancer
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Ovarian Cancer
Lead sponsor: BeiGene
Sponsor class: INDUSTRY
First posted: 2018-05-08
Enrollment: 224
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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/Exclusion criteria may apply.

Primary outcomes:
measure: Progression free survival (PFS) by blinded Independent Review Committee (BIRC) assessment
timeFrame: up to 8 years
Secondary outcomes:
measure: Overall survival
timeFrame: up to 9 years
measure: Objective response rate by investigator assessment
timeFrame: up to 2 years
measure: Duration of response by investigator assessment
timeFrame: up to 2 years
measure: PFS by investigator assessment
timeFrame: up to 8 years
measure: Time to response by investigator assessment
timeFrame: up to 8 years
measure: Number of participants with treatment-emergent adverse events (TEAEs)
timeFrame: up to 9 years
Other outcomes:
Locations:
city: Hefei
country: China
facility: Anhui Provincial Cancer Hospital Aka West Branch of Anhui Province Hospital
state: Anhui
city: Beijing
country: China
facility: Peking University First Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Cancer Hospital
state: Beijing
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
city: Chongqing
country: China
facility: Chongqing Cancer Hospital
state: Chongqing
city: Chongqing
country: China
facility: Southwest Hospital
state: Chongqing
city: Guangzhou
country: China
facility: Sun Yat Sen Memorial Hospital, Sun Yat Sen University (North)
state: Guangdong
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Guangzhou Medical University
state: Guangdong
city: Shantou
country: China
facility: Cancer Hospital of Shantou University Medical College
state: Guangdong
city: Nanning
country: China
facility: The Tumor Hospital Affiliated to Guangxi Medical University
state: Guangxi
city: Harbin
country: China
facility: Harbin Medical University Cancer Hospital
state: Heilongjiang
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
state: Henan
city: Wuhan
country: China
facility: Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
city: Wuhan
country: China
facility: Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology
state: Hubei
city: Wuhan
country: China
facility: Hubei Cancer Hospital
state: Hubei
city: Changsha
country: China
facility: Hunan Cancer Hospital
state: Hunan
city: Nanchang
country: China
facility: Jiangxi Maternal and Child Health Hospital
state: Jiangxi
city: Changchun
country: China
facility: Jilin Cancer Hospital
state: Jilin
city: Changchun
country: China
facility: The First Hospital of Jilin University
state: Jilin
city: Dalian
country: China
facility: The Second Hospital of Dalian Medical University
state: Liaoning
city: Shenyang
country: China
facility: Liaoning Cancer Hospital and Institute
state: Liaoning
city: Jinan
country: China
facility: Qilu Hospital of Shandong University
state: Shandong
city: Yantai
country: China
facility: Yantai Yuhuangding Hospital
state: Shandong
city: Shanghai
country: China
facility: Obstetrics and Gynecology Hospital of Fudan University
state: Shanghai
city: Chengdu
country: China
facility: West China Second University Hospital
state: Sichuan
city: Tianjin
country: China
facility: Tianjin Central Hospital of Gynecology Obstetrics
state: Tianjin
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Institute and Hospital
state: Tianjin
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
state: Zhejiang
Study officials:
affiliation: BeiGene
name: Study Director
role: STUDY_DIRECTOR
References: