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    Summary
    EudraCT Number:2013-004810-16
    Sponsor's Protocol Code Number:TPU-TAS-120-101
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2017-12-12
    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 ConcernedGermany - BfArM
    A.2EudraCT number2013-004810-16
    A.3Full title of the trial
    PHASE 1/2 STUDY OF TAS-120 IN PATIENTS WITH ADVANCED SOLID TUMORS HARBORING FGF/FGFR ABERRATIONS
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study of TAS-120 in patients with advanced cancer with genetic abnormalities
    A.4.1Sponsor's protocol code numberTPU-TAS-120-101
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02052778
    A.5.4Other Identifiers
    Name:IND NumberNumber:121062
    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 SponsorTaiho Oncology 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 supportTaiho Oncology Inc
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationTaiho Oncology, Inc
    B.5.2Functional name of contact pointHead of Clinical Development
    B.5.3 Address:
    B.5.3.1Street Address101 Carnegie Center, Suite 101
    B.5.3.2Town/ cityPrinceton
    B.5.3.3Post codeNJ 08540
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1609750-5300
    B.5.5Fax number+1609 750-7450
    B.5.6E-mailjhuang@taihooncology.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 Yes
    D.2.5.1Orphan drug designation numberC(2019) 2662
    D.3 Description of the IMP
    D.3.1Product nameTAS-120
    D.3.2Product code TAS-120
    D.3.4Pharmaceutical form 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 INNNot yet assigned
    D.3.9.1CAS number 1448169-71-8
    D.3.9.2Current sponsor codeTAS-120
    D.3.9.3Other descriptive nameTAS-120
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4
    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
    Advanced solid tumors
    E.1.1.1Medical condition in easily understood language
    Advanced solid tumors
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10065147
    E.1.2Term Malignant solid 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
    Phase 1 Dose Escalation: completed
    Phase 1 Expansion
    •To evaluate ORR in cholangiocarcinoma patients with tumors harboring FGFR2 gene fusions or other FGFR abnormalities
    • To evaluate ORR and EPR (defined as progression-free rate at the end of Cycle 2) in patients with primary CNS tumors harboring FGFR gene fusions or FGFR1 activating mutations
    • To evaluate ORR in a basket of tumor types with tumors harboring FGFR2 amplifications
    •To evaluate ORR in a basket of tumor types with tumors harboring any FGFR gene fusions or activating mutations

    Phase 2: • To confirm ORR in iCCA patients with FGFR2 gene fusions or other FGFR2 rearrangements based on independent central radiology review.
    E.2.2Secondary objectives of the trial
    Phase 1 Dose Escalation: completed
    Phase 1 Expansion
    •To investigate the safety of TAS-120.
    •To evaluate disease control rate (DCR), DOR, PFS and OS in each treatment group.

    Phase 2:
    Key secondary
    •To evaluate DOR
    Other secondary
    •To evaluate the safety and tolerability of TAS-120
    •To evaluate DCR, PFS, and OS
    •To evaluate Patient-Reported Outcomes (PROs)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Provide written informed consent.
    2. Is ≥ 18 years
    3. Has histologically or cytologically confirmed, locally advanced,
    metastatic cancer meeting the following criteria:
    a. Phase 1 Expansion
    i. Patient has failed all standard therapies or standard therapy does not
    exist or is not tolerated.
    ii. Patient is eligible for 1 of the following enrollment groups, based on
    diagnosis, prior therapy, and FGF/FGFR aberrations as shown:
    Group 1 (Enrollment Suspended as of Amendment 7): Patient has
    intrahepatic or extrahepatic cholangiocarcinoma harboring FGFR2 gene
    fusions.
    Group 2: Patient has intrahepatic or extrahepatic cholangiocarcinoma
    harboring FGFR2 gene fusions, and has not received or received less
    than 1 cycle of prior chemotherapy (due to intolerance or patient
    refusal).
    Group 3 (Enrollment Suspended as of Amendment 7): Patient has
    intrahepatic or extrahepatic cholangiocarcinoma harboring FGFR2 gene
    fusions and has received prior treatment with FGFR inhibitors.
    Group 4 (Enrollment suspended as of Amendment 7): Patient has
    intrahepatic or extrahepatic cholangiocarcinoma harboring FGFR
    abnormalities other than FGFR2 gene fusions
    Group 5: Patient has a primary CNS tumor harboring FGFR gene fusion or
    FGFR1 activating mutation and fulfills the criteria (i and ii).
    Group 6 (Enrollment Suspended as of Amendment 7): Patient has
    advanced urothelial carcinoma harboring FGFR3 fusions or FGFR3
    activating mutations.
    Group 7: Patient has any tumor type not included in one of the prior
    groups, harboring FGFR2 amplification (no minimum number of copies).
    Group 8 (Enrollment Suspended as of Amendment 7): Patient has any
    tumor type not included in one of the prior groups, harboring FGFR gene
    fusions or activating mutations.
    b. Phase 2
    i. Patient has histologically or cytologically confirmed, locally advanced,
    metastatic, unresectable iCCA harboring FGFR2 gene fusions or other
    FGFR2 rearrangements based on results from either of the following
    a. Testing by Foundation Medicine:
    i. As part of study pre-screening; or
    ii. Previously tested by Foundation Medicine; in this case, it is requested
    that tumor tissue should be provided to Foundation Medicine if available.
    b. Local laboratory testing using next generation sequencing [NGS],
    fluorescence in situ hybridization [FISH], or other assays that can
    determine FGFR2 gene fusions or other FGFR2 rearrangements on tumor
    tissues or from ctDNA; it is requested that patients enrolled on this basis
    provide tumor tissues to Foundation Medicine if available from either
    archival samples or fresh tumor biopsy.
    ii. Patient has been treated with at least one prior systemic gemcitabine
    and platinum-based chemotherapy. Patients with prior adjuvant
    gemcitabine-platinum chemotherapy are eligible if the patient had
    recurrence within 6 months of the last dose of the regimen.
    iii. Patient has documentation of radiographic disease progression on
    the most recent prior therapy
    4. Patient has measurable disease as defined by Response Evaluation
    Criteria in Solid Tumors (RECIST) guidelines (version 1.1, 2009) for
    advanced solid tumors or RANO criteria (2010) for brain tumors.
    5. Eastern Cooperative Oncology Group (ECOG) performance status 0 or
    1 on Day 1 of Cycle 1
    6. Able to take medications orally
    7. Adequate organ function as defined by the following criteria:
    a. Aspartate aminotransferase (AST) and alanine aminotransferase
    (ALT) ≤ 3.0 ×upper limit of normal (ULN); if liver function abnormalities
    are due to underlying liver metastasis, AST and ALT ≤ 5 × ULN.
    b. Total bilirubin ≤ 1.5 × ULN, or ≤ 3.0 mg/dL for patients with Gilbert's
    syndrome.
    c. International normalized ratio (INR) <1.3 (or < 3.0 on
    anticoagulants)
    d. Absolute neutrophil count ≥ 1000/mm3 (i.e., ≥ 1.0 × 109/L by
    International Units [IU])
    e. Platelet count ≥ 75,000/mm3 (IU: ≥ 75 × 109/L)
    f. Hemoglobin ≥ 9.0 g/dL
    g. Phosphorus ≤ ULN.
    8. Creatinine clearance (calculated* or measured value**): ≥ 40
    mL/min
    9. Women of child-bearing potential (WOCBP) must have a negative
    pregnancy test (urine or serum) within 7 days prior to administration of
    the first dose of TAS 120. Female patients are not considered to be of
    child bearing potential if they have a history of hysterectomy or are post
    menopausal defined as no menses for 12 months without an alternative
    medical cause. Both males and females of reproductive potential must
    agree to use effective birth control during the study prior to the first
    dose and for 6 months after the last dose.
    10. Willing and able to comply with scheduled visits and study
    procedures
    E.4Principal exclusion criteria
    1. History and/or current evidence of clinically significant non-tumor related alteration of calcium-phosphorus homeostasis.
    2. History and/or current evidence of clinically significant ectopic mineralization/calcification.
    3. History and/or current evidence of clinically significant retinal disorder confirmed by retinal examination.
    4. History or current evidence of serious uncontrolled ventricular arrhythmias
    5. Fridericia’s corrected QT interval (QTcF) > 470 ms on ECG conducted during Screening.
    6. Treatment with any of the following within the specified time frame prior to the first dose of TAS-120:
    a. Major surgery within the previous 4 weeks (the surgical incision should be fully healed prior to the first dose of TAS 120).
    b. Radiotherapy for extended field within 4 weeks or limited field radiotherapy within 2 weeks.
    c. Patients with locoregional therapy, e.g., transarterial chemoembolization (TACE), selective internal radiotherapy (SIRT) or ablation within 4 weeks.
    d. Any noninvestigational anticancer therapy within 3 weeks or have not recovered from side effects of such therapy prior to TAS 120 administration (mitomycin within prior 5 weeks).
    • Targeted therapy or immunotherapy within 3 weeks or within 5 half-lives (whichever is shorter)
    e. Any investigational agent received within 5 half-lives of the drug or 4 weeks, whichever is shorter. Concurrent participation in an observational study may be allowed after review by the Sponsor’s Medical Monitor.
    f. Patients with prior FGFR-directed therapy.
    7. A serious illness or medical condition(s) including, but not limited to, the following:
    a. Known brain metastasis (not including primary brain tumors) unless patient is clinically stable for ≥ 1 month.
    b. Known acute systemic infection.
    c. Myocardial infarction, severe/unstable angina, symptomatic congestive heart failure (New York Heart Association [NYHA] Class III or IV (see Appendix D, New York Heart Association [NYHA] Classification) within the previous 2 months; if > 2 months, cardiac function must be within normal limits and the patient must be free of cardiac-related symptoms.
    d. Chronic nausea, vomiting, or diarrhea considered to be clinically significant in the opinion of the investigator.
    e. Congenital long QT syndrome, or any known history of torsade de pointes, or family history of unexplained sudden death.
    f. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that in the judgment of the investigator would make the patient inappropriate for entry into this study.
    8. Patients with a history of another primary malignancy that is currently clinically significant, and has potential for metastases or currently requires active intervention (except for gonadotropin-releasing hormone (GnRH) or luteinizing hormone-releasing hormone (LH-RH) agonists in prostate cancer or adjuvant hormonal therapy in breast cancer).
    9. Pregnant or lactating female.
    E.5 End points
    E.5.1Primary end point(s)
    For Phase 1 Expansion, the primary endpoint is ORR in each treatment group (and EPR for primary CNS tumors).
    For Phase 2, the primary endpoint is ORR.
    Primary endpoints will be based on the independent review of images by the Core Imaging Laboratory. In addition, for the Phase 2 part of the study, sensitivity analyses for some key efficacy endpoints (e.g., ORR, and PFS) will be performed based on investigators or local radiologist assessments.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The endpoint is based on Overall response rate (ORR).

    E.5.2Secondary end point(s)
    For Phase 1 Expansion, secondary endpoints of DOR, DCR, PFS, and OS in each treatment group.
    For Phase 2, secondary endpoints of DOR, DCR, PFS, PROs and OS.
    Primary endpoints will be based on the independent review of images by the Core Imaging Laboratory. In addition, for the Phase 2 part of the study, sensitivity analyses for some key efficacy endpoints (e.g., ORR, and PFS) will be performed based on investigators or local radiologist assessments.
    E.5.2.1Timepoint(s) of evaluation of this end point
    The assessment of DCR will parallel that of ORR, with DCR defined as the proportion of patients with objective evidence of CR, PR, or SD, except that there is no requirement for a confirmation of an SD response, if it is maintained for at least 6 weeks post treatment initiation.
    Disease control rate will be analyzed using the same methodology as ORR.
    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 Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    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 Yes
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    dose-escalation and dose-expansion
    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 EEA25
    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
    Canada
    France
    Germany
    Hong Kong
    Italy
    Japan
    Korea, Republic of
    Netherlands
    Portugal
    Spain
    Taiwan
    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
    For the Phase 1 Expansion part of the study, patients in each treatment group should be followed for survival for up to 12 months after the last patient enrolled in that group.
    For Phase 2, patients should be followed for survival for up to 18 months after the last patient enrolled in this phase of the study.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months8
    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: 352
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 233
    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 Yes
    F.3.3.7.1Details of other specific vulnerable populations
    Patients have incurable disease - advanced metastatic solid tumor(s)
    F.4 Planned number of subjects to be included
    F.4.1In the member state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 200
    F.4.2.2In the whole clinical trial 385
    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)
    None.
    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 Decision2018-04-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-09-20
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2024-10-22
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