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Completed

NCT Number: NCT03333915

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

This study is designed to evaluate the safety, tolerability, PKharmacokinetic 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.

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Key information

Conditions

Advanced High-grade Ovarian Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases Triple Negative Breast Cancer Triple Negative Breast Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Beijing Cancer Hospital, Beijing, Beijing Municipality, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 triple-negative breast cancer or epithelial, non-mucinous, high-grade ovarian cancer (including fallopian cancer, or primary peritoneal cancer), for which no effective standard therapy is available.
  • 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.
  • 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.

Treatment and study plan

Pamiparib

Drug

Pamiparib is provided as oral capsules

Other names: BGB-290

Primary outcomes

  1. Phase 1: Number of Participants With Treatment- Emergent Adverse Events (TEAE) and Serious Adverse Events (SAE)

    Time frame: From first dose to within 30 days of last dose of pamiparib (approximately 36 months)

    A TEAE is defined as an adverse event (AE) that had an onset date on or after the first dose of study drug up to 30 days following study drug discontinuation or was worsening in severity from baseline (pretreatment).

  2. Phase 1: Number of Participants With Clinically Significant Abnormalities in Physical Examinations and Electrocardiograms (ECGs)

    Time frame: From first dose to within 30 days of last dose of pamiparib (approximately 36 months)

  3. Phase 2: Objective Response Rate (ORR) in High Grade Ovarian Cancer (HGOC) Both PSOC and PROC as Assessed by Independent Radiology Review Committee (IRC)

    Time frame: Up to approximately 2 years and 8 months

    ORR is defined as the percentage of participants with confirmed Complete Response or Partial Response

Secondary outcomes

  1. Phase I: Maximum Observed Plasma Concentration (Cmax)

    Time frame: Cycle 1 Day 1 and Day 10 of 21-day cycle: pre-dose, 0.5, 1, 2, 4, 6,9 and 12 hours post dose

  2. Phase I: Time to Reach Cmax (Tmax)

    Time frame: Cycle 1 Day 1 and Day 10 of 21-day cycle: pre-dose, 0.5, 1, 2, 4, 6,9 and 12 hours post dose

  3. Phase I: Terminal Elimination Half-life (t1/2)

    Time frame: Cycle 1 Day 1 of 21-day cycle: pre-dose, 0.5, 1, 2, 4, 6,9 and 12 hours post dose

  4. Phase I: Apparent Clearance (CL/F)

    Time frame: Cycle 1 Day 1 of 21-day cycle: pre-dose, 0.5, 1, 2, 4, 6,9 and 12 hours post dose

  5. Phase 1: Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinity (AUCinf)

    Time frame: Cycle 1 Day 1 of 21-day cycle: pre-dose, 0.5, 1, 2, 4, 6,9 and 12 hours post dose

  6. Phase I: Apparent Volume of Distribution During Terminal Phase (Vz/F)

    Time frame: Cycle 1 Day 1 of 21-day cycle: pre-dose, 0.5, 1, 2, 4, 6,9 and 12 hours post dose

  7. Phase I: Confirmed Objective Response Rate (ORR) as Assessed by the Investigator Per RECIST v1.1

    Time frame: Up to approximately 36 months

    ORR is defined as the percentage of participants with confirmed Complete Response (CR) or Partial Response (PR)

  8. Phase 1: Disease Control Rate (DCR) Assessed by the Investigator Per RECIST v1.1

    Time frame: Up to approximately 36 months

    DCR is defined as the percentage of participants with best overall response (BOR) of CR, PR and stable disease (SD)

  9. Phase I: Clinical Benefit Rate (CBR) Assessed by the Investigator Per RECIST v1.1

    Time frame: Up to approximately 36 months

    CBR is defined as percentage of participants with best overall response of CR, PR and stable disease (SD)≥24 weeks

  10. Phase 1: Duration of Response (DOR) as Assessed by Investigator Per RECIST v1.1

    Time frame: Up to approximately 36 months

    DOR is defined as the time from the first determination of a confirmed overall response until the first documentation of progression or death, whichever comes first

  11. Phase I : Progression Free Survival (PFS)

    Time frame: Up to approximately 36 months

    PFS is defined as the time from first dose of study medication to the first documented disease progression or death due to any cause, whichever occurs first

  12. Phase 2: Objective Response Rate (ORR) by Investigator Per RECIST v1.1

    Time frame: Up to approximately 3 years and 8 months

    ORR is defined as the percentage of participants with confirmed Complete Response or Partial Response

  13. Phase 2: Disease Control Rate by Investigator Per RECIST v1.1

    Time frame: Up to approximately 3 years and 8 months

    DCR is defined as the percentage of participants with best overall response (BOR) of CR, PR and stable disease (SD)

  14. Phase 2: Clinical Benefit Rate by Investigator Per RECIST v1.1

    Time frame: Up to approximately 3 years and 8 months

    CBR is defined as percentage of participants with best overall response of CR, PR and stable disease (SD)≥24 weeks

  15. Phase 2: Carcinoma Antigen-125 (C(A-125) Response Rate by Gynecologic Cancer Inter Group (GCIG )Criteria

    Time frame: Up to approximately 3 years and 8 months

    CA-125 response is defined the percentage of participants with at least 50% reduction in CA-125 levels from pre-treatment sample

  16. Phase 2: Duration of Response as Assessed by Investigator Per RECIST v1.1

    Time frame: Up to approximately 3 years and 8 months

    DOR is defined as the time from the first determination of a confirmed overall response until the first documentation of progression or death, whichever comes first

  17. Phase 2: Progression Free Survival as Assessed by the Investigator Per RECIST v1.1

    Time frame: Up to approximately 3 years and 8 months

    PFS is defined as the time from first dose of study medication to the first documented disease progression or death due to any cause, whichever occurs first

  18. Phase 2: Overall Survival (OS) as Assessed by Investigator

    Time frame: Up to approximately 3 years and 8 months

    OS is defined as time from the first dose of study medication to the date of death due to any cause

  19. Phase 2: Number of Participants With Treatment- Emergent Adverse Events and Serious Adverse Events

    Time frame: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)

    A TEAE is defined as an adverse event (AE) that had an onset date on or after the first dose of study drug up to 30 days following study drug discontinuation or was worsening in severity from baseline (pretreatment). All clinically significant abnormalities in physical examinations, laboratory tests and ECGs are reported as adverse events (AE) in the AE section.

  20. Phase 2: Area Under the Plasma Concentration-time Curve From 0 to 12 Hours Post-dose (AUC0-12)

    Time frame: Cycle 1 Day 1 and Cycle 2 Day 1: pre-dose, 0.5, 1, 2, 4, 6,9 and 12 hours post dose

  21. Phase 2: Maximum Observed Plasma Concentration (Cmax)

    Time frame: Cycle 1 Day 1 and Cycle 2 Day 1: pre-dose, 0.5, 1, 2, 4, 6,9 and 12 hours post dose

  22. Phase 2: Time to Reach Cmax (Tmax)

    Time frame: Cycle 1 Day 1 and Cycle 2 Day 1: pre-dose, 0.5, 1, 2, 4, 6,9 and 12 hours post dose

  23. Phase 2: Area Under the Plasma Concentration-time Curve From 0 to the 9 Hours Post-dose (AUC0-9)

    Time frame: Cycle 1 Day 1 and Cycle 2 Day 1: pre-dose, 0.5, 1, 2, 4, 6,9 and 12 hours post dose

Sponsors and collaborators

Lead sponsor

BeiGene

Industry

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2020
Study completion
2021
First posted
Nov 7, 2017
Registry last updated
Feb 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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