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    Summary
    EudraCT Number:2018-003584-53
    Sponsor's Protocol Code Number:Debio1347-201
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2018-12-07
    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 ConcernedFrance - ANSM
    A.2EudraCT number2018-003584-53
    A.3Full title of the trial
    A Phase II basket study of the oral selective pan-FGFR inhibitor Debio 1347 in subjects with solid tumors harboring a fusion of FGFR1, FGFR2 or FGFR3
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    An efficacy study of the oral drug Debio 1347 in patients with solid tumors having an alteration of FGFR 1-3 (fusion)
    A.3.2Name or abbreviated title of the trial where available
    The FUZE Clinical Trial
    A.4.1Sponsor's protocol code numberDebio1347-201
    A.5.4Other Identifiers
    Name:IND numberNumber:118244
    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 SponsorDebiopharm International SA
    B.1.3.4CountrySwitzerland
    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 supportDebiopharm International SA
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDebiopharm International SA
    B.5.2Functional name of contact pointClinical department
    B.5.3 Address:
    B.5.3.1Street AddressChemin Messidor 5-7
    B.5.3.2Town/ cityLausanne
    B.5.3.3Post code1002
    B.5.3.4CountrySwitzerland
    B.5.4Telephone number0041 21 3210111
    B.5.5Fax number0041 21 3210169
    B.5.6E-mailClinicalTrials@debiopharm.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 numberEU/3/17/1916
    D.3 Description of the IMP
    D.3.2Product code Debio 1347
    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.3.9.1CAS number 1265231-80-8
    D.3.9.2Current sponsor codeDebio 1347
    D.3.9.3Other descriptive nameDEBIO 1347, Debio 1347 malate, FF284, CH5183284, C-025675
    D.3.9.4EV Substance CodeSUB120700
    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.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
    Three cohorts will be included consisting of subjects with biliary tract cancer (Cohort 1), urothelial cancer (Cohort 2) and all other solid tumor histologies not included in Cohorts 1-2 such as NSCLC, head and neck cancer, thyroid cancer, oral cancer, breast cancer, prostate cancer and others but excluding primary brain tumors (Cohort 3).
    E.1.1.1Medical condition in easily understood language
    Solid Tumors (Cancer)
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    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 assess the efficacy of Debio 1347 in terms of ORR in subjects with solid tumors harboring FGFR1-3 gene fusion/rearrangement.
    E.2.2Secondary objectives of the trial
    1. To evaluate the efficacy of Debio 1347 in terms of DoR, DCR, PFS and OS.
    2. To assess the safety of Debio 1347.
    3. To assess exposure-response relationships vs efficacy and safety (notably QTcF).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Written informed consent given according to ICH/GCP guidelines and local regulations.
    2. Cytologically or histologically confirmed advanced solid tumor.
    3. Radiographic progression on prior systemic therapy; prior localized therapy (i.e., radiation, ablation, embolization) is allowed provided radiographic progression out-of-field or in the treatment field is shown.
    4. Male or female ≥18 years of age.
    5. Locally-advanced (unresectable) or metastatic disease harboring an FGFR1-3 gene fusion/rearrangement potentially leading to a functional FGFR aberrant protein, identified through local and/or central molecular assay.
    6. At least one prior standard therapy appropriate for tumor type and stage of disease. In particular:
    a. Biliary tract cancer subjects must have progressed on/after gemcitabine-based chemotherapy (including subjects who progressed within 6 months of gemtabicine-based adjuvant chemotherapy). Subjects can have received additional chemotherapy after documented intolerance to gemcitabine.
    b. Urothelial cancer subjects must have progressed on/after cisplatin-based or carboplatinbased chemotherapy either given for advanced disease or within 12 months from completion if given as neoadjuvant or adjuvant therapy and anti-PD1/PDL1 therapy (unless not available, contraindicated for some reasons or refused by the patient).
    c. NSCLC subjects must have progressed on chemotherapy and anti PD1/PDL1 therapy (unless contraindicated for some reasons). Subjects with known EGFR mutations, ALK rearrangement or BRAF V600E mutation must have received the relevant target therapy (unless not available).
    d. For all other tumor types, subjects must have progressed on/after appropriate SOC therapy (evidence-based level 1). Subjects who harbor genomic aberrations for which approved target therapy is available must have received such therapy. HER2+ or ER/PR+ breast cancer subjects should have received at least one line of HER2-targeted or ER-targeted, respectively.
    7. Measurable disease according to RECIST criteria version 1.1.

    For further Inclusion Criteria please refer to the Protocol.
    E.4Principal exclusion criteria
    1. History of hypersensitivity to any of the excipients in the Debio 1347 formulation.
    2. Prior treatment with a FGFR1-3 selective inhibitor.
    3. History and/or current evidence of ectopic mineralization/calcification, including but not limited to soft tissue, kidneys, intestine, myocardia, or lung, excepting calcified lymph nodes, lung nodules and asymptomatic vascular or cartilage/tendon calcifications.
    4. Current evidence of clinically significant corneal or retinal disorder confirmed by ophthalmologic examination.
    5. Chemotherapy or radiotherapy within 2 weeks prior to initial dosing with Debio 1347.
    6. Administration of any investigational agent within 2 weeks prior to initial dosing with Debio 1347 (3 weeks for immune checkpoint inhibitors).
    7. Surgery requiring general anesthesia, except diagnostic biopsy or local procedure, within 3 weeks prior to initial dosing with Debio 1347 and/or if the subject has not fully recovered from the surgery.
    8. Grade > 1 NCI-CTCAE v5.0 AEs or toxicities from previous treatments except:
    a. Albumin (≥ 2.5 g/dL is allowed).
    b. AST and ALT in subjects with liver metastases.
    c. ALP in subjects with bone metastases .
    d. Any grade of alopecia is allowed.
    e. Other Grade 1-2 clinically insignificant laboratory abnormalities are allowed.

    For further Exclusion Criteria please refer to the Protocol.
    E.5 End points
    E.5.1Primary end point(s)
    ORR (defined as the proportion of subjects with a BOR of partial or complete response) as centrally measured by RECIST 1.1 criteria.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Throughout the study
    E.5.2Secondary end point(s)
    1. DoR (defined as the time from the date of the initial partial or complete response to date of the first documented progression or death due to any cause).
    2. DCR (defined as the proportion of subjects with a BOR of CR or PR or SD).
    3. PFS (defined as the time from the start date of treatment to date of the first documented progression or death due to any cause).
    4. OS (defined as the time from the start date of treatment to date of death due to any cause).
    5. Proportion of subjects with TEAEs assessed by NCI-CTCAE v5.0 and SAEs.
    6. Debio 1347 plasma exposure (Ctrough, AUCī´ and any other PK parameters as deemed appropriate) and relationships with efficacy and safety endpoints; Debio 1347 plasma concentration (C)-QTcF relationship based on ECG and PK matching time-points.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Throughout the study
    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 No
    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) 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.8.2.4Number of treatment arms in the trial1
    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 concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA44
    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
    Austria
    Brazil
    Bulgaria
    Canada
    Croatia
    Czech Republic
    Denmark
    Finland
    France
    Germany
    Greece
    Korea, Republic of
    Mexico
    Netherlands
    Norway
    Philippines
    Poland
    Romania
    Russian Federation
    Singapore
    Spain
    Taiwan
    Thailand
    Turkey
    Ukraine
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee Yes
    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
    The study will be considered as completed 2 years at the most after the last subject discontinued treatment.
    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: 65
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 60
    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 state4
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 40
    F.4.2.2In the whole clinical trial 125
    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)
    N/A
    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 Decision2019-01-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-02-05
    P. End of Trial
    P.End of Trial StatusCompleted
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