Back to resultsStudy of the Efficacy, Safety and Pharmacokinetics of Pamiparib (BGB-290) in Participants With Advanced Solid Tumors
Primary Purpose
Advanced High-grade Ovarian Cancer, Triple Negative Breast Cancer
Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Pamiparib
Sponsored by
About this trial
This is an interventional treatment trial for Advanced High-grade Ovarian Cancer
Eligibility Criteria
Key Inclusion Criteria:
- Participants have voluntarily agreed to participate by giving written informed consent.
- Age 18 years (including 18 years) on the day of signing informed consent.
- Participants meet the following eligibility criteria for the corresponding part of the study: 1) In Phase 1 portion: The participants must have a histologically or cytologically confirmed locally advanced or metastatic cancer, either TNBC or epithelial, non-mucinous, HGOC (including fallopian cancer, or primary peritoneal cancer), for which no effective standard therapy is available. 2) In Phase 2 portion: Participants who have histologically or cytologically confirmed high-grade epithelial ovarian cancer (including fallopian cancer or primary peritoneal cancer), harboring germline BRCA1/2 mutation
- Participants must have measurable disease as defined per the RECIST, version 1.1.
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤1
Key Exclusion Criteria:
- Participants who have been treated with chemotherapy, biologic therapy, immunotherapy, investigational agent, anti-cancer Chinese medicine, or anticancer herbal remedies ≤ 14 days (or ≤5 half-lives, whichever is shorter) prior to starting study drug, or who have not adequately recovered from the side effects of such therapy.
- Participants who have undergone major surgery for any cause ≤ 4 weeks prior to starting study drug. Participants must have adequately recovered from the previous treatment and have a stable clinical condition before entering the study.
- Participants who have undergone radiotherapy for any cause ≤ 14 days prior to starting study drug. Participants must have adequately recovered from the previous treatment and have a stable clinical condition before entering the study.
- Untreated and/or active brain metastases.
- Prior therapies targeting poly (ADP-ribose) polymerase (PARP).
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Sites / Locations
- Anhui Provincial Cancer Hospital
- Cancer Hospital Chinese Academy of Medical Sciences
- Peking Union Medical College Hospital
- Peking University First Hospital
- Peking University People Hospital
- Beijing Cancer Hospital
- The First Bethune Hospital of Jilin University
- Chongqing Cancer Hospital
- SUN YAT-SEN memorial hospital,SUN YAT-SEN University
- Harbin Medical University Cancer Hospital
- Henan Cancer Hospital
- Union Hospital Tongji Medical College Huazhong University of Science and Technology
- Hubei Cancer Hospital
- Hunan Cancer Hospital
- Jiangsu Province Hospital
- Jiangxi Maternal and Child Health Hospital
- Jilin Cancer Hospital
- The second Hospital of Jilin University
- The First Hospital of Dalian Medical University
- The First Affiliated Hospital of Xian Jiaotong University
- Liaoning Cancer Hospital&Institute
- QILU Hospital of Shandong University
- Fudan University Shanghai Cancer Center
- West China Hospital Sichuan University
- Tianjin Medical University Cancer institute & Hospital
- Zhejiang Cancer Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
High-grade ovarian cancer and triple negative breast cancer
Arm Description
Outcomes
Primary Outcome Measures
Phase I:Number of participants with treatment-related adverse events assessed by NCI-CTCAE v4.03 Phase II: Objective response rate
Phase II: Objective response rate by RECIST v1.1
Secondary Outcome Measures
Phase I: Objective response rate, disease control rate and clinical benefit rate by RECIST v1.1
Phase I: Duration of response by RECIST v1.1
Phase I：Progression free survival
Phase I: Area under the plasma concentration-time curve from 0 to the last measurable concentration (AUClast)
Phase I: Maximum observed plasma concentration (Cmax)
Phase I: Time to reach Cmax (Tmax)
Phase I: Terminal elimination half-life (t1/2)
Phase I: Apparent clearance (CL/F)
Phase I: Apparent volume of distribution during terminal phase (Vz/F）
Phase II: Disease control rate and clinical benefit rate by RECIST v1.1 and CA125 response rate by GCIG criteria
Phase II: Duration of response by RECIST v1.1
Phase II: Progression free survival
Phase II: Overall survival
Phase II: Number of participants with treatment-related adverse events assessed by NCI-CTCAE v4.03
Phase II: Pharmacokinetics parameters as mentioned above for selected participants
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03333915
Brief Title
Study of the Efficacy, Safety and Pharmacokinetics of Pamiparib (BGB-290) in Participants With Advanced Solid Tumors
Official Title
An Open Label, Multi-Center Phase I/II Study to Evaluate Efficacy and Safety of BGB-290 in Chinese Subjects With Advanced Ovarian Cancer, Fallopian Cancer, and Primary Peritoneal Cancer or Advanced Triple Negative Breast Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Unknown status
Study Start Date
December 21, 2016 (Actual)
Primary Completion Date
February 2, 2020 (Actual)
Study Completion Date
November 30, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
BeiGene
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study is designed to evaluate the safety, tolerability, PK profile and treatment effect of pamiparib in Chinese participants with advanced high-grade ovarian cancer (including fallopian cancer or primary peritoneal cancer) and triple negative breast cancer in phase I, and to evaluate the efficacy and safety of pamiparib in Chinese participants with recurrent epithelial ovarian cancer (including fallopian cancer or primary peritoneal cancer), harboring germline breast cancer susceptibility gene 1/gene 2 (BRCA1/2) mutation in phase II.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced High-grade Ovarian Cancer, Triple Negative Breast Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
128 (Actual)
8. Arms, Groups, and Interventions
Arm Title
High-grade ovarian cancer and triple negative breast cancer
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Pamiparib
Other Intervention Name(s)
BGB-290
Intervention Description
Pamiparib is provided as oral capsules，Three dose levels will be evaluated as 20mg, 40mg, 60mg separately， twice a day in phase I and will be used with single dose based on RP2D in phase II.
Primary Outcome Measure Information:
Title
Phase I:Number of participants with treatment-related adverse events assessed by NCI-CTCAE v4.03 Phase II: Objective response rate
Time Frame
Phase I:From first dose to within 30 days of last dose of BGB-290 (pamiparib)
Title
Phase II: Objective response rate by RECIST v1.1
Time Frame
From first dose of BGB-290 to the first documented disease progression or death due to any cause, whichever came first，, assessed up to 5 years
Secondary Outcome Measure Information:
Title
Phase I: Objective response rate, disease control rate and clinical benefit rate by RECIST v1.1
Time Frame
Every 6 weeks from first dose until the date of first documented progression or date of death from any cause, whichever came first，assessed up to 5 years
Title
Phase I: Duration of response by RECIST v1.1
Time Frame
Every 6 weeks from first dose until the date of first documented progression or date of death from any cause, whichever came first，assessed up to 5 years
Title
Phase I：Progression free survival
Time Frame
From first dose of BGB-290 to the first documented disease progression or death due to any cause, whichever came first，assessed up to 5 years
Title
Phase I: Area under the plasma concentration-time curve from 0 to the last measurable concentration (AUClast)
Time Frame
During first 7 weeks
Title
Phase I: Maximum observed plasma concentration (Cmax)
Time Frame
During first 7 weeks
Title
Phase I: Time to reach Cmax (Tmax)
Time Frame
During first 7 weeks
Title
Phase I: Terminal elimination half-life (t1/2)
Time Frame
During first 7 weeks
Title
Phase I: Apparent clearance (CL/F)
Time Frame
During first 7 weeks
Title
Phase I: Apparent volume of distribution during terminal phase (Vz/F）
Time Frame
During first 7 weeks
Title
Phase II: Disease control rate and clinical benefit rate by RECIST v1.1 and CA125 response rate by GCIG criteria
Time Frame
Every 6 weeks from first dose until the date of first documented progression or date of death from any cause, whichever came first，assessed up to 5 years
Title
Phase II: Duration of response by RECIST v1.1
Time Frame
Every 6 weeks from first dose until the date of first documented progression or date of death from any cause, whichever came first，assessed up to 5 years
Title
Phase II: Progression free survival
Time Frame
From first dose of BGB-290 to the first documented disease progression or death due to any cause, whichever came first，assessed up to 5 years
Title
Phase II: Overall survival
Time Frame
From first dose of BGB-290 to death due to any cause，assessed up to 5 years
Title
Phase II: Number of participants with treatment-related adverse events assessed by NCI-CTCAE v4.03
Time Frame
From first dose to within 30 days of last dose of BGB-290
Title
Phase II: Pharmacokinetics parameters as mentioned above for selected participants
Time Frame
During first 7 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria:
Participants have voluntarily agreed to participate by giving written informed consent.
Age 18 years (including 18 years) on the day of signing informed consent.
Participants meet the following eligibility criteria for the corresponding part of the study: 1) In Phase 1 portion: The participants must have a histologically or cytologically confirmed locally advanced or metastatic cancer, either TNBC or epithelial, non-mucinous, HGOC (including fallopian cancer, or primary peritoneal cancer), for which no effective standard therapy is available. 2) In Phase 2 portion: Participants who have histologically or cytologically confirmed high-grade epithelial ovarian cancer (including fallopian cancer or primary peritoneal cancer), harboring germline BRCA1/2 mutation
Participants must have measurable disease as defined per the RECIST, version 1.1.
Eastern Cooperative Oncology Group (ECOG) performance status of ≤1
Key Exclusion Criteria:
Participants who have been treated with chemotherapy, biologic therapy, immunotherapy, investigational agent, anti-cancer Chinese medicine, or anticancer herbal remedies ≤ 14 days (or ≤5 half-lives, whichever is shorter) prior to starting study drug, or who have not adequately recovered from the side effects of such therapy.
Participants who have undergone major surgery for any cause ≤ 4 weeks prior to starting study drug. Participants must have adequately recovered from the previous treatment and have a stable clinical condition before entering the study.
Participants who have undergone radiotherapy for any cause ≤ 14 days prior to starting study drug. Participants must have adequately recovered from the previous treatment and have a stable clinical condition before entering the study.
Untreated and/or active brain metastases.
Prior therapies targeting poly (ADP-ribose) polymerase (PARP).
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiaohua Wu, MD
Organizational Affiliation
Fudan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Anhui Provincial Cancer Hospital
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230001
Country
China
Facility Name
Cancer Hospital Chinese Academy of Medical Sciences
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100021
Country
China
Facility Name
Peking Union Medical College Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100032
Country
China
Facility Name
Peking University First Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100034
Country
China
Facility Name
Peking University People Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100034
Country
China
Facility Name
Beijing Cancer Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100142
Country
China
Facility Name
The First Bethune Hospital of Jilin University
City
Jilin
State/Province
Changchun
ZIP/Postal Code
130021
Country
China
Facility Name
Chongqing Cancer Hospital
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400030
Country
China
Facility Name
SUN YAT-SEN memorial hospital,SUN YAT-SEN University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
528400
Country
China
Facility Name
Harbin Medical University Cancer Hospital
City
Harbin
State/Province
Heilongjiang
ZIP/Postal Code
150000
Country
China
Facility Name
Henan Cancer Hospital
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450008
Country
China
Facility Name
Union Hospital Tongji Medical College Huazhong University of Science and Technology
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430030
Country
China
Facility Name
Hubei Cancer Hospital
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430079
Country
China
Facility Name
Hunan Cancer Hospital
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410006
Country
China
Facility Name
Jiangsu Province Hospital
City
Nanjing
State/Province
Jiangsu
Country
China
Facility Name
Jiangxi Maternal and Child Health Hospital
City
Nanchang
State/Province
Jiangxi
ZIP/Postal Code
330006
Country
China
Facility Name
Jilin Cancer Hospital
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130021
Country
China
Facility Name
The second Hospital of Jilin University
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130022
Country
China
Facility Name
The First Hospital of Dalian Medical University
City
Dalian
State/Province
Liaoning
ZIP/Postal Code
116044
Country
China
Facility Name
The First Affiliated Hospital of Xian Jiaotong University
City
Dalian
State/Province
Liaoning
ZIP/Postal Code
215000
Country
China
Facility Name
Liaoning Cancer Hospital&Institute
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110042
Country
China
Facility Name
QILU Hospital of Shandong University
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250012
Country
China
Facility Name
Fudan University Shanghai Cancer Center
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Facility Name
West China Hospital Sichuan University
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Facility Name
Tianjin Medical University Cancer institute & Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300070
Country
China
Facility Name
Zhejiang Cancer Hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310022
Country
China
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Study of the Efficacy, Safety and Pharmacokinetics of Pamiparib (BGB-290) in Participants With Advanced Solid Tumors
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