Clincosm LogoSign in Get a demo

Study of the Efficacy, Safety and Pharmacokinetics of Pamiparib (BGB-290) in Participants With Advanced Solid Tumors

Sponsor
BeiGene (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT03333915
Collaborator
(none)
128
Enrollment
26
Locations
1
Arm
59.3
Anticipated Duration (Months)
4.9
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 1/Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
128 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Dec 21, 2016
Actual Primary Completion Date :
Feb 2, 2020
Anticipated Study Completion Date :
Nov 30, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: High-grade ovarian cancer and triple negative breast cancer

Drug: Pamiparib
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.
Other Names:
  • BGB-290

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Phase I:Number of participants with treatment-related adverse events assessed by NCI-CTCAE v4.03 Phase II: Objective response rate [Phase I:From first dose to within 30 days of last dose of BGB-290 (pamiparib)]

    2. Phase II: Objective response rate by RECIST v1.1 [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 Measures

    1. Phase I: Objective response rate, disease control rate and clinical benefit rate by RECIST v1.1 [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]

    2. Phase I: Duration of response by RECIST v1.1 [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]

    3. Phase I：Progression free survival [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]

    4. Phase I: Area under the plasma concentration-time curve from 0 to the last measurable concentration (AUClast) [During first 7 weeks]

    5. Phase I: Maximum observed plasma concentration (Cmax) [During first 7 weeks]

    6. Phase I: Time to reach Cmax (Tmax) [During first 7 weeks]

    7. Phase I: Terminal elimination half-life (t1/2) [During first 7 weeks]

    8. Phase I: Apparent clearance (CL/F) [During first 7 weeks]

    9. Phase I: Apparent volume of distribution during terminal phase (Vz/F） [During first 7 weeks]

    10. Phase II: Disease control rate and clinical benefit rate by RECIST v1.1 and CA125 response rate by GCIG criteria [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]

    11. Phase II: Duration of response by RECIST v1.1 [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]

    12. Phase II: Progression free survival [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]

    13. Phase II: Overall survival [From first dose of BGB-290 to death due to any cause，assessed up to 5 years]

    14. Phase II: Number of participants with treatment-related adverse events assessed by NCI-CTCAE v4.03 [From first dose to within 30 days of last dose of BGB-290]

    15. Phase II: Pharmacokinetics parameters as mentioned above for selected participants [During first 7 weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Key Inclusion Criteria:

    1. Participants have voluntarily agreed to participate by giving written informed consent.

    2. Age 18 years (including 18 years) on the day of signing informed consent.

    3. 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

    4. Participants must have measurable disease as defined per the RECIST, version 1.1.

    5. Eastern Cooperative Oncology Group (ECOG) performance status of ≤1

    Key Exclusion Criteria:

    1. 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.

    2. 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.

    3. 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.

    4. Untreated and/or active brain metastases.

    5. Prior therapies targeting poly (ADP-ribose) polymerase (PARP).

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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Anhui Provincial Cancer Hospital Hefei Anhui China 230001
    2 Cancer Hospital Chinese Academy of Medical Sciences Beijing Beijing China 100021
    3 Peking Union Medical College Hospital Beijing Beijing China 100032
    4 Peking University First Hospital Beijing Beijing China 100034
    5 Peking University People Hospital Beijing Beijing China 100034
    6 Beijing Cancer Hospital Beijing Beijing China 100142
    7 The First Bethune Hospital of Jilin University Jilin Changchun China 130021
    8 Chongqing Cancer Hospital Chongqing Chongqing China 400030
    9 SUN YAT-SEN memorial hospital,SUN YAT-SEN University Guangzhou Guangdong China 528400
    10 Harbin Medical University Cancer Hospital Harbin Heilongjiang China 150000
    11 Henan Cancer Hospital Zhengzhou Henan China 450008
    12 Union Hospital Tongji Medical College Huazhong University of Science and Technology Wuhan Hubei China 430030
    13 Hubei Cancer Hospital Wuhan Hubei China 430079
    14 Hunan Cancer Hospital Changsha Hunan China 410006
    15 Jiangsu Province Hospital Nanjing Jiangsu China
    16 Jiangxi Maternal and Child Health Hospital Nanchang Jiangxi China 330006
    17 Jilin Cancer Hospital Changchun Jilin China 130021
    18 The second Hospital of Jilin University Changchun Jilin China 130022
    19 The First Hospital of Dalian Medical University Dalian Liaoning China 116044
    20 The First Affiliated Hospital of Xian Jiaotong University Dalian Liaoning China 215000
    21 Liaoning Cancer Hospital&Institute Shenyang Liaoning China 110042
    22 QILU Hospital of Shandong University Jinan Shandong China 250012
    23 Fudan University Shanghai Cancer Center Shanghai Shanghai China 200032
    24 West China Hospital Sichuan University Chengdu Sichuan China 610041
    25 Tianjin Medical University Cancer institute & Hospital Tianjin Tianjin China 300070
    26 Zhejiang Cancer Hospital Hangzhou Zhejiang China 310022

    Sponsors and Collaborators

    • BeiGene

    Investigators

    • Principal Investigator: Xiaohua Wu, MD, Fudan University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    BeiGene
    ClinicalTrials.gov Identifier:
    NCT03333915
    Other Study ID Numbers:
    • BGB-290-102
    • CTR20160828
    First Posted:
    Nov 7, 2017
    Last Update Posted:
    Jun 18, 2021
    Last Verified:
    Jun 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Breast Neoplasms
    Ovarian Neoplasms
    Carcinoma, Ovarian Epithelial
    Triple Negative Breast Neoplasms

    Study Results

    No Results Posted as of Jun 18, 2021