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    Summary
    EudraCT Number:2014-000501-13
    Sponsor's Protocol Code Number:EORTC-1317-STBSG
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-10-26
    Trial results View 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 ConcernedHungary - National Institute of Pharmacy
    A.2EudraCT number2014-000501-13
    A.3Full title of the trial
    Phase II study of cabozantinib in patients with metastatic gastrointestinal stromal tumor (GIST) who progressed during neoadjuvant, adjuvant or palliative therapy with imatinib and sunitinib.
    A kabozantinib II. fázisú vizsgálata metasztatikus gastrointestinalis stromalis tumorban (GIST) szenvedő betegeknél, akiknek súlyosbodott az állapota imatinibbel és a szunitinibbel végzett neoadjuváns, adjuváns vagy palliatív terápia során.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase II study of cabozantinib in patients with metastatic gastrointestinal stromal tumor (GIST) who progressed during neoadjuvant, adjuvant or palliative therapy with imatinib and sunitinib.
    A kabozantinib II. fázisú vizsgálata metasztatikus gastrointestinalis stromalis tumorban (GIST) szenvedő betegeknél, akiknek súlyosbodott az állapota imatinibbel és a szunitinibbel végzett neoadjuváns, adjuváns vagy palliatív terápia során.
    A.3.2Name or abbreviated title of the trial where available
    Ph II CABOGIST in GIST
    A.4.1Sponsor's protocol code numberEORTC-1317-STBSG
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02216578
    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 SponsorEuropean Organisation for Research and Treatment of Cancer (EORTC)
    B.1.3.4CountryBelgium
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportExelixis
    B.4.2CountryUnited States
    B.4.1Name of organisation providing supportEuropean Organisation for the Research and Treatment of cancer
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationEuropean Organisation for the Research and Treatment of Cancer (EORTC)
    B.5.2Functional name of contact pointRegulatory Affairs Department
    B.5.3 Address:
    B.5.3.1Street AddressAvenue E. Mounier 83/11
    B.5.3.2Town/ cityBrussels
    B.5.3.3Post code1200
    B.5.3.4CountryBelgium
    B.5.4Telephone number+322774 1074
    B.5.5Fax number+322772 7063
    B.5.6E-mailregulatory@eortc.org
    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.3.1Product nameCabozantinib
    D.3.2Product code XL184
    D.3.4Pharmaceutical form Film-coated tablet
    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 INNCABOZANTINIB
    D.3.9.1CAS number 1140909-48-3
    D.3.9.4EV Substance CodeSUB93452
    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: 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 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.3.1Product nameCabozantinib
    D.3.2Product code XL184
    D.3.4Pharmaceutical form Film-coated tablet
    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 INNCABOZANTINIB
    D.3.9.1CAS number 1140909-48-3
    D.3.9.4EV Substance CodeSUB93452
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number60
    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
    metastatic gastrointestinal stromal tumor (GIST)
    E.1.1.1Medical condition in easily understood language
    gastrointestinal stromal tumour (GIST -, a cancer of the stomach and
    bowel) that has spread
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10062427
    E.1.2Term Gastrointestinal stromal tumor
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The main objective is to assess the safety and activity of cabozantinib in patients with metastatic GIST who have previously progressed on imatinib and sunitinib and have not been exposed yet to other KIT- or PDGFR-directed tyrosine kinase inhibitors such as regorafenib or similar agents.
    E.2.2Secondary objectives of the trial
    Secondary objectives of the trial include:
    ♦To assess the relative efficacy of cabozantinib in different mutational subtypes of GIST based on both archived tumor material derived from the primary tumor or a metastatic site, and mutations detected in circulating cell-free DNA using centralized mutational analysis.
    ♦To explore the use of circulating cell-free DNA (“liquid biopsy”) for centralized mutational analysis in GIST.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    ♦ Histologically confirmed diagnosis of GIST that is metastatic.
    ♦ Presence of at least one non-previously irradiated, measurable metastatic lesion as defined by RECIST 1.1
    ♦ Radiographic absence of a cavitating pulmonary lesion within 28 days prior to the first dose of cabozantinib
    ♦ Consent of the patient
    ♦ Failure on prior therapy with imatinib and sunitinib
    ♦ Male or female patient ≥ 18 years of age
    ♦ ECOG performance status (PS) of 0-1
    ♦ Adequate bone marrow and organ function prior to receiving the first dose of study treatment
    ♦ Clinically normal cardiac function
    ♦ Patients must be able to swallow and retain oral film-coated tablets
    ♦ Recovery to baseline or ≤ Grade 1 CTCAE v.4.0 from toxicities related to any prior treatments
    ♦ Prior radiation therapy patients with clinically relevant ongoing complications from prior radiation therapy are not eligible
    ♦ Prior surgery:
    - Minor surgery within 28 days before the first dose of study treatment with complete wound healing at least 10 days before the first dose of study treatment is permitted
    - Patients with clinically relevant ongoing complications from prior surgery are not eligible
    ♦ Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests and other study procedures.
    ♦ Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
    ♦ Women of child bearing potential (WOCBP) must have a negative serum pregnancy test within 72 hours prior to the first dose of study treatment.
    ♦ Patients of childbearing / reproductive potential should use adequate birth control measures, as defined by the investigator, during the study treatment period and for at least 4 months after the last study treatment. A highly effective method of birth control is defined as a method which results in a low failure rate (i.e. less than 1% per year) when used consistently and correctly. Such methods include:
    ♦ Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal)
    ♦ Progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable)
    ♦ Intrauterine device (IUD)
    ♦ Intrauterine hormone-releasing system (IUS)
    ♦ Bilateral tubal occlusion
    ♦ Vasectomized partner
    ♦ Sexual abstinence
    ♦ Before patient registration, written informed consent must be given according to international conference on harmonization/Good clinical practice (ICH/GCP), and national/local regulations.
    E.4Principal exclusion criteria
    ♦ Evidence of tumor or metastatic lesion invading the gastrointestinal tract within 28 days prior to the first dose of cabozantinib
    ♦ Current evidence of endotracheal or endobronchial tumor within 28 days before the first dose of cabozantinib
    ♦ Patient with tumor in contact with, invading or encasing a major blood vessel
    ♦ Prior use of tyrosine kinase inhibitors for the treatment of advanced GIST with the exception of imatinib and sunitinib
    ♦ Other investigational agents within 28 days before the first dose of study treatment
    ♦ History of congenital long QT syndrome
    ♦ QTcF> 500 msec within 1 month before the first dose of study treatment
    ♦ Congestive heart failure
    ♦ History of unstable angina, clinically significant cardiac arrhythmias and myocardial infarction within 6 months prior to the first dose of protocol treatment
    ♦ Poorly controlled hypertension
    ♦ Concomitant anticoagulation at therapeutic doses with oral anticoagulants
    ♦ Specific contraindications for treatment with cabozantinib
    ♦ Stroke and thromboembolic event requiring therapeutic anticoagulation within 6 months before the first dose of study treatment
    ♦ Gastrointestinal disorders associated with a high risk of perforation or fistula formation
    ♦ Other clinically significant disorders that would preclude safe study
    participation
    ♦ Evidence of significant active bleeding or bleeding diathesis within 6 months before the first dose of study treatment
    ♦ Hemoptysis ≥ 0.5 teaspoon of red blood within 3 months before the first dose of study treatment
    ♦ Signs indicative of pulmonary hemorrhage within 3 months before the first dose of study treatment
    ♦ Prior radiation therapy:
    - Radiation therapy for bone metastasis within 2 weeks, or any other external radiation therapy within 4 weeks before the first dose of study treatment.
    - Systemic treatment with radionuclides within 6 weeks before the first dose of study treatment.
    ♦ Prior surgery major surgery or trauma within 12 weeks prior to first dose of study drug and/or presence of any non-healing wound, fracture or ulcer.
    ♦ Active infection requiring systemic treatment within 28 days before the first dose of study treatment.
    ♦ History of organ transplant.
    ♦ Concurrent severe, clinically relevant hypothyroidism or thyroid dysfunction within 7 days before the first dose of study treatment
    ♦ History of other malignancy in the past 5 years with the exception of treated carcinoma in situ of the cervix and non-metastatic, non-melanoma skin cancer
    ♦ Patients requiring chronic concomitant treatment with strong Cytochrome P450 (CYP) 3A4 inducers
    ♦ Lactating females
    E.5 End points
    E.5.1Primary end point(s)
    Progression free survival at 12 weeks (binary) according to RECIST 1.1.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Tumor evaluations for the assessment of PFS will be done every 6 weeks during the first 48 weeks and every 12 weeks thereafter until PD or start of new treatment for GIST after stopping cabozantinib
    E.5.2Secondary end point(s)
    The secondary endpoints include:
    ♦ PFS according to RECIST 1.1.
    ♦ Overall survival (OS).
    ♦ Objective response rate (ORR), defined as a complete or partial response (CR or PR) according to RECIST 1.1.Clinical benefit rate (CBR) defined as CR, PR, or SD according to RECIST 1.1.Total duration of treatment (including treatment beyond RECIST progression).
    ♦ Safety (graded according to the Common Terminology Criteria for Adverse Events, CTC-AE, version 4.0).
    E.5.2.1Timepoint(s) of evaluation of this end point
    - Tumor evaluations for the assessment of PFS will be done every 6 weeks during the first 48 weeks and every 12 weeks thereafter until PD or start of new treatment for GIST after stopping cabozantinib.
    - OS: every 3 weeks during cabozantinib treatment, thereafter every 12 weeks until death
    - Safety: every 3 weeks during cabozantinib treatment + at 30 days after last administration of study drug
    - ORR: Tumor evaluations for the assessment of ORR will be done every 6 weeks during the first 48 weeks and every 12 weeks thereafter until cabozantinib treatment discontinuation
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    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 Yes
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA10
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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
    End of study occurs when all of the following criteria have been satisfied:
    1. Thirty days after all patients have stopped protocol treatment.
    2. The trial is mature for the analysis of the primary endpoint as defined in the protocol
    3. The database has been fully cleaned and frozen for this analysis
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    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.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 15
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 35
    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 state8
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 41
    F.4.2.2In the whole clinical trial 41
    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)
    The treatment will be left to the discretion of the treating physician.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2017-01-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-01-05
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-02-23
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