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    Summary
    EudraCT Number:2017-001553-14
    Sponsor's Protocol Code Number:BGB-290-103
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:GB - no longer in EU/EEA
    Date on which this record was first entered in the EudraCT database:2017-11-08
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedUK - MHRA
    A.2EudraCT number2017-001553-14
    A.3Full title of the trial
    A Phase 1b Study to Assess the Safety, Tolerability, and Clinical Activity of BGB-290 in Combination with Temozolomide (TMZ) in Subjects with Locally Advanced or Metastatic Solid Tumors
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A safety and efficacy study of the drug BGB-290 in combination with Temozolomide (TMZ) in patients with ovarian, breast, prostate, lung and stomach cancer.
    A.4.1Sponsor's protocol code numberBGB-290-103
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03150810
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorBeiGene USA, Inc.
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportBeiGene USA, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBeiGene USA, Inc.
    B.5.2Functional name of contact pointClinical Trial Information Email
    B.5.3 Address:
    B.5.3.1Street Address2115 Linwood Avenue
    B.5.3.2Town/ cityFort Lee
    B.5.3.3Post codeNJ 07024
    B.5.3.4CountryUnited States
    B.5.6E-mailclinicaltrials@beigene.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.2Product code BGB-290
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 1446261-44-4
    D.3.9.3Other descriptive nameBGB-290
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Temozolomide Accord 20 mg hard capsules
    D.2.1.1.2Name of the Marketing Authorisation holderAccord Healthcare Limited
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameTemozolomide Accord 20 mg hard capsules
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNtemozolomide
    D.3.9.1CAS number 85622-93-1
    D.3.9.3Other descriptive nameTEMOZOLOMIDE
    D.3.9.4EV Substance CodeAS2
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 3
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Temozolomide Accord 100 mg hard capsules
    D.2.1.1.2Name of the Marketing Authorisation holderAccord Healthcare Limited
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameTemozolomide Accord 100 mg hard capsules
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNtemozolomide
    D.3.9.1CAS number 85622-93-1
    D.3.9.3Other descriptive nameTEMOZOLOMIDE
    D.3.9.4EV Substance CodeAS3
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Locally Advanced or Metastatic Solid Tumors (ovarian cancer, triple negative breast cancer (TNBC), metastatic castration-resistant prostate cancer (mCRPC), small cell lung cancer (SCLC), and gastric cancer)
    E.1.1.1Medical condition in easily understood language
    Ovarian, breast, prostate, lung , stomach cancer
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    • To determine the safety and tolerability of pamiparib (also known as
    BGB-290)when given orally in combination with temozolomide (TMZ) (pulsed and continuous)
    • To determine the maximum tolerated dose (MTD) or maximum administered dose (MAD) for pamiparib combined with TMZ (pulsed and continuous)
    • To select the recommended Phase 2 dose (RP2D) and schedule of BGB-290 in combination with TMZ
    • To determine the preliminary antitumor activity of pamiparib in
    combination with TMZ
    E.2.2Secondary objectives of the trial
    • To characterize the pharmacokinetics (PK) of BGB-290 and TMZ
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    All subjects:
    1.Age ≥18 years old.
    2.Confirmed malignancy at advanced or metastatic stage.
    3.ECOG status ≤ 1.
    4.Adequate bone marrow function.
    5.Adequate renal and hepatic function.
    6. Agree to provide tumor archival tissue

    Additional inclusion criteria 8 - 12 are specific to tumor types in dose expansion phase:
    Ovarian cancer:
    1.Previously received at least 1 line of platinum containing chemotherapy.
    2.No progression or recurrent disease in 6 months from last platinum containing regimen.

    Triple-Negative Breast Cancer
    0 - 1 prior platinum-containing regimen (any treatment setting) and received ≤ 3 prior regimens (advanced or metastatic setting).

    Metastatic Castration-Resistant Prostate cancer
    1.Documented progressive disease.
    2.Chemotherapy-naïve or previously received ≤2 taxane-based regimens.
    3.May be pre-or post-treatment with a novel androgen receptor targeted agent.
    4.Completed in ≥ 2 weeks radiation or treatment with anti-androgen agents.

    Ovarian, breast and prostate cancer (BRCA+ or HRD+): If homologous recombinant deficiency (HRD) or BRCA status unknown, need pre-screening for eligibility.

    Extensive Stage Small cell lung and Gastric/Gastroesophageal Junction
    Cancer cancer: received ≤ 2 prior lines of therapy.

    HRD+ Solid Tumors. Multiple Indications (Expansion Cohort 6)
    a. Patient has histologic or cytologic-confirmed advanced (metastatic and/or unresectable)
    - nonsquamous non-small cell lung cancer (NSCLC)
    - squamous NSCLC
    - esophageal cancer
    - squamous head and neck cancer
    - soft-tissue sarcomas (undifferentiated pleomorphic sarcoma,leiomyosarcoma, malignant peripheral nerve sheath tumor, dedifferentiated liposarcoma, myxofibrosarcoma)
    b. Patients must have tumors with homologous recombination deficiency (HRD+) as centrally determined by the Myriad myChoice® HRD Plus assay irrespective of any known molecular signature
    c. Patients with nonsquamous NSCLC, squamous NSCLC, esophageal cancer and squamous head and neck cancer must have received at least 1 but not more than 3 prior lines of therapy
    d. Patients with soft tissue sarcoma must have received at least 1 but no more than 3 prior lines of therapy. Treatment naïve patients may be allowed if, in the opinion of the investigator, available standard of care first line therapy is not appropriate
    Other protocol-defined inclusion criteria may apply (see protocol for details).
    E.4Principal exclusion criteria
    All subjects
    1.Prior exposure to a PARP inhibitor.
    2.Prior chemotherapy, biologic therapy, immunotherapy or investigational agents within 3 weeks prior to start of study treatment.
    3.Refractory to platinum-based therapy.
    4. Any unresolved toxicity of ≥ Grade 2 from prior therapy.
    5.Major surgery or significant injury ≤ 4 weeks prior to start of study treatment.
    6.History of other active malignancies within 2 years with exception of (i) adequately treated in situ carcinoma of the cervix, (ii) non-melanoma skin cancer, or (iii) localized adequately treated cancer with curative intent or malignancy diagnosed > 2 years ago with no evidence of disease and no treatment ≤ 2 years prior to study treatment.
    7.Untreated leptomeningeal or brain metastasis.
    8.Active infection requiring systemic treatment.
    9.Known human immunodeficiency virus (HIV) or active viral hepatitis.
    10.Active, clinically significant cardiac disease or any Class 3 or 4 cardiac disease, ventricular arrhythmia or CVA ≤ 6 months prior to start of treatment.
    11.Active, clinically significant gastrointestinal disease.
    12.Use of any medications or food known to be strong or moderate cytochrome P450, family 3, subfamily A (CYP3A) inhibitors or strong inducers.
    13.Pregnant or nursing females.
    14. Have hereditary problems of galactose intolerance, the Lapp lactase
    deficiency, or glucose-galactose malabsorption
    E.5 End points
    E.5.1Primary end point(s)
    Expansion: Incidence, nature, and severity of AEs, graded according to the NCI CTCAE v. 4.03
    Objective response rate (ORR), as assessed using RECIST v1.1
    E.5.1.1Timepoint(s) of evaluation of this end point
    during weekly visits; for AE collection: during weekly visits for the first 5 cycles, every 28 days after cycle 5, EOT, safety follow-up visit
    E.5.2Secondary end point(s)
    1) Pharmacokinetic (PK) parameters (Cmax) of pamiparib and TMZ
    2) Pharmacokinetic (PK) parameters (Tmax) of pamiparib and TMZ
    3) Objective response rate (ORR) as assessed using RECIST v 1.1
    4) Duration of response (DOR)
    5) Disease control rate (DCR)
    6) Progression free survival (PFS)
    7) Overall survival (OS)
    E.5.2.1Timepoint(s) of evaluation of this end point
    1,2: Cycle 1 Day 1/7/15
    3, 4, 5, 6: Within 4 weeks prior to Day 1; every 8 weeks; EOT; every 8 weeks during Efficacy Follow-up
    7: Every 3 months post EOT
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    dose escalation
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned9
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA12
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    Spain
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months2
    E.8.9.1In the Member State concerned days15
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 150
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 100
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 40
    F.4.2.2In the whole clinical trial 250
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    At this time, there are no plans to provide further treatment after patients ended their participation in the trial.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2017-12-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-06-29
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
    The status of studies in GB is no longer updated from 1.1.2021
    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
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