Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT03333915
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03333915
Recruitment Status : Active, not recruiting
First Posted : November 7, 2017
Last Update Posted : June 2, 2020
Sponsor:
Information provided by (Responsible Party):
BeiGene

Tracking Information
First Submitted Date  ICMJE November 1, 2017
First Posted Date  ICMJE November 7, 2017
Last Update Posted Date June 2, 2020
Actual Study Start Date  ICMJE December 21, 2016
Actual Primary Completion Date February 2, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 27, 2019)
  • 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) ]
  • 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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: November 2, 2017)
Number of participants with adverse events [ Time Frame: From first dose to within 30 days of last dose of BGB-290 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 29, 2020)
  • 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 ]
  • 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 ]
  • 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 ]
  • Phase I: Area under the plasma concentration-time curve from 0 to the last measurable concentration (AUClast) [ Time Frame: During first 7 weeks ]
  • Phase I: Maximum observed plasma concentration (Cmax) [ Time Frame: During first 7 weeks ]
  • Phase I: Time to reach Cmax (Tmax) [ Time Frame: During first 7 weeks ]
  • Phase I: Terminal elimination half-life (t1/2) [ Time Frame: During first 7 weeks ]
  • Phase I: Apparent clearance (CL/F) [ Time Frame: During first 7 weeks ]
  • Phase I: Apparent volume of distribution during terminal phase (Vz/F) [ Time Frame: During first 7 weeks ]
  • 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 ]
  • 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 ]
  • 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 ]
  • Phase II: Overall survival [ Time Frame: From first dose of BGB-290 to death due to any cause,assessed up to 5 years ]
  • 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 ]
  • Phase II: Pharmacokinetics parameters as mentioned above for selected participants [ Time Frame: During first 7 weeks ]
Original Secondary Outcome Measures  ICMJE
 (submitted: November 2, 2017)
  • Area under the plasma concentration-time curve from 0 to the last measureable concentration (AUClast) [ Time Frame: From pre-dose to the end of cycle 3 (Cycle 1 and cycle 2 are 21 days, cycle 3 is 42 days) ]
  • Maximum plasma concentration (Cmax) [ Time Frame: From pre-dose to the end of cycle 3 (Cycle 1 and cycle 2 are 21 days, cycle 3 is 42 days) ]
  • Terminal half-life (t1/2) [ Time Frame: From pre-dose to the end of cycle 3 (Cycle 1 and cycle 2 are 21 days, cycle 3 is 42 days) ]
  • Apparent clearance (CL/F) [ Time Frame: From pre-dose to the end of cycle 3 (Cycle 1 and cycle 2 are 21 days, cycle 3 is 42 days) ]
  • Apparent volume of distribution (Vz/F) [ Time Frame: From pre-dose to the end of cycle 3 (Cycle 1 and cycle 2 are 21 days, cycle 3 is 42 days) ]
  • Objective response rate [ Time Frame: From first dose BGB-290 to first documentation of disease progression, assessed up to 1 year ]
  • Disease control rate [ Time Frame: From first dose BGB-290 to first documentation of disease progression, assessed up to 1 year ]
  • Clinical benefit rate [ Time Frame: From first dose BGB-290 to first documentation of disease progression, assessed up to 1 year ]
  • Progression-free survival [ Time Frame: From first dose BGB-290 to first documentation of disease progression, assessed up to 1 year ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of the Efficacy, Safety and Pharmacokinetics of Pamiparib (BGB-290) in Participants With Advanced Solid Tumors
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Advanced High-grade Ovarian Cancer
  • Triple Negative Breast Cancer
Intervention  ICMJE 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 Name: BGB-290
Study Arms  ICMJE Experimental: High-grade ovarian cancer and triple negative breast cancer
Intervention: Drug: Pamiparib
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: August 23, 2019)
128
Original Estimated Enrollment  ICMJE
 (submitted: November 2, 2017)
85
Estimated Study Completion Date  ICMJE November 30, 2021
Actual Primary Completion Date February 2, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03333915
Other Study ID Numbers  ICMJE BGB-290-102
CTR20160828 ( Registry Identifier: ChiCTR )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Responsible Party BeiGene
Study Sponsor  ICMJE BeiGene
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Xiaohua Wu, MD Fudan University
PRS Account BeiGene
Verification Date May 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP