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Trial record 1 of 1 for:    NCT03333915
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Study of the Efficacy, Safety and Pharmacokinetics of BGB-290 in Subjects With Advanced Solid Tumors

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ClinicalTrials.gov Identifier: NCT03333915
Recruitment Status : Recruiting
First Posted : November 7, 2017
Last Update Posted : July 19, 2019
Sponsor:
Information provided by (Responsible Party):
BeiGene

Brief Summary:
This study is designed to evaluate the safety, tolerability, PK profile and treatment effect of BGB-290 (pamiparib) in Chinese advanced cancer subjects in phase I, and to evaluate the efficacy and safety of BGB-290 (pamiparib) in Chinese patients with advanced 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
Advanced Solid Tumors Drug: Pamiparib Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 115 participants
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 : November 29, 2016
Estimated Primary Completion Date : February 28, 2020
Estimated Study Completion Date : November 30, 2021


Arm Intervention/treatment
Experimental: Solid Tumor,BGB-290 Drug: Pamiparib
Pamiparib is provided as oral capsules,Three dose levels will be evaluated as 20mg, 40mg, 60mg separately, twice a day.
Other Name: BGB-290




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 [ Time Frame: 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 [ 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 Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. Phase I: Area under the plasma concentration-time curve from 0 to the last measurable concentration (AUClast) [ Time Frame: During first 7 weeks ]
  5. Phase I: Maximum observed plasma concentration (Cmax) [ Time Frame: During first 7 weeks ]
  6. Phase I: Time to reach Cmax (Tmax) [ Time Frame: During first 7 weeks ]
  7. Phase I: Terminal elimination half-life (t1/2) [ Time Frame: During first 7 weeks ]
  8. Phase I: Apparent clearance (CL/F) [ Time Frame: During first 7 weeks ]
  9. Phase I: Apparent volume of distribution during terminal phase (Vz/F) [ Time Frame: 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 [ 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 ]
  11. 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 ]
  12. 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 ]
  13. Phase II: Overall survival [ Time Frame: 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 [ Time Frame: From first dose to within 30 days of last dose of BGB-290 ]
  15. Phase II: Pharmacokinetics parameters as mentioned above for selected patients [ Time Frame: During first 7 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients 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. Patients meet the following eligibility criteria for the corresponding part of the study: 1) In Phase 1 portion: The patients 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: Patients who have histologically or cytologically confirmed high-grade epithelial ovarian cancer (including fallopian cancer or primary peritoneal cancer), harboring germline BRCA1/2 mutation
  4. Patients must have measurable disease as defined per the RECIST, version 1.1.
  5. Eastern Cooperative Oncology Group (ECOG) performance status of ≤1

Exclusion Criteria:

  1. Patients 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. Patients who have undergone major surgery for any cause ≤ 4 weeks prior to starting study drug. Patients must have adequately recovered from the previous treatment and have a stable clinical condition before entering the study.
  3. Patients who have undergone radiotherapy for any cause ≤ 14 days prior to starting study drug. Patients 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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03333915


Contacts
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Contact: Miao Li, MD 1-877-828-5568 ClinicalTrials@beigene.com

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Sponsors and Collaborators
BeiGene
Investigators
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Principal Investigator: Binghe Xu Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Principal Investigator: Xiaohua Wu Fudan University

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Responsible Party: BeiGene
ClinicalTrials.gov Identifier: NCT03333915     History of Changes
Other Study ID Numbers: BGB-290-102
CTR20160828 ( Registry Identifier: Center for drug evaluation, CFDA )
First Posted: November 7, 2017    Key Record Dates
Last Update Posted: July 19, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No