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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 : Unknown
Verified June 2021 by BeiGene.
Recruitment status was:  Active, not recruiting
First Posted : November 7, 2017
Last Update Posted : June 18, 2021
Sponsor:
Information provided by (Responsible Party):
BeiGene

Study Description
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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
Advanced High-grade Ovarian Cancer Triple Negative Breast Cancer Drug: Pamiparib Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
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 : December 21, 2016
Actual Primary Completion Date : February 2, 2020
Estimated Study Completion Date : November 30, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 Name: BGB-290


Outcome Measures
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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 participants [ Time Frame: During first 7 weeks ]

Eligibility Criteria
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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

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
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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


Locations
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Sponsors and Collaborators
BeiGene
Investigators
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Principal Investigator: Xiaohua Wu, MD Fudan University
More Information
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Responsible Party: BeiGene
ClinicalTrials.gov Identifier: NCT03333915    
Other Study ID Numbers: BGB-290-102
CTR20160828 ( Registry Identifier: ChiCTR )
First Posted: November 7, 2017    Key Record Dates
Last Update Posted: June 18, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Triple Negative Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Endocrine Gland Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
 Urogenital Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Genital Diseases
Endocrine System Diseases
Gonadal Disorders
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Pamiparib
Poly(ADP-ribose) Polymerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents