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    Summary
    EudraCT Number:2016-001193-15
    Sponsor's Protocol Code Number:FASTERCC-001
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2016-05-18
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2016-001193-15
    A.3Full title of the trial
    Folic acid supplement versus placebo for treating mucositis adverse events in metastatic renal cell carcinoma patients receiving targeted therapy (FASTERCC).

    A randomized, double-blind, phase II trial from the Danish renal cancer group (DARENCA study-4).
    Folinsyretilskud versus placebo som behandling af slimhindebivirkninger ved metastatisk renalcellecarcinom (FASTERCC).
    Et randomiseret, placebo-kontrolleret, dobbelt-blændet, fase II-studie omhandlende effekten af folinsyretilskud på slimhindeforandringer hos patienter i behandling med tyrolinkinasehæmmer eller mTOR-hæmmer for metastatisk renalcellecarcinom.
    Et DARENCA-4 studie.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Folic acid supplement versus placebo for treating side effects due to cancer treatment in metastatic renal cell carcinoma (FASTERCC).
    A Danish renal cancer group study (DARENCA-4).
    Folinsyretilskud som behandling af bivirkninger ved behandling af metastatisk renalcellecarcinom (FASTERCC).
    Et studie fra den danske nyrecancergruppe (DARENCA-4 studiet).
    A.3.2Name or abbreviated title of the trial where available
    Folic Acid Supplement for Treating adverse Events in metastatic Renal Cell Carcinoma (FASTERCC).
    Folinsyretilskud som behandling af bivirkninger ved metastatisk renalcellecarcinom (FASTERCC).
    A.4.1Sponsor's protocol code numberFASTERCC-001
    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 SponsorDepartment of Oncology, Aarhus University Hospital
    B.1.3.4CountryDenmark
    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 supportNovartis
    B.4.2CountryDenmark
    B.4.1Name of organisation providing supportMediLink
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDepartment of Oncology, Aarhus University Hospital
    B.5.2Functional name of contact pointNiels Fristrup MD PhD
    B.5.3 Address:
    B.5.3.1Street AddressPalle Juul-Jensens Blvd 99
    B.5.3.2Town/ cityAarhus N
    B.5.3.3Post code8200
    B.5.3.4CountryDenmark
    B.5.4Telephone number004520914161
    B.5.5Fax number004589492530
    B.5.6E-mailniels.fristrup@rm.dk
    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 Yes
    D.2.1.1.1Trade name Folimet
    D.2.1.1.2Name of the Marketing Authorisation holderMediLink A/S Gammelmosevej 176A DK-2800 Kgs. Lyngby Danmark
    D.2.1.2Country which granted the Marketing AuthorisationDenmark
    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 nameFolimet
    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 INNpteroylglutamate
    D.3.9.3Other descriptive nameFOLIC ACID
    D.3.9.4EV Substance CodeSUB07774MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Mucositis (nasal, oral, pharyngeal, anal, or genital) is often experienced in relation to TKI and mTOR inhibitor treatment of metastatic renal cell carcinoma patients. The present trial will assess whether a complementary treatment with folic acid in patients displaying mucositis ≥2 based on the Common Terminology Criteria for Adverse Events v. 4.0 (CTCAE) can reduce the degree of mucositis, compared to PLACEBO.
    Mucositis (nasal, oral, pharyngeal, anal eller genital) ses ofte som bivirkning ved behandling med TKI eller mTOR-hæmmer hos metastatiske renalcellecarcinom-patienter. Dette studie vil undersøge om folinsyretilskud kan reducere graden af mucositis målt med CTCAE bivirkningsscoring, sammenlignet med PLACEBO.
    E.1.1.1Medical condition in easily understood language
    Mucositis due to cancer treatment of metastatic renal cell carcinoma.
    Slimhindepåvirkning som følge af den medicinske behandling af metastatisk nyrecancer.
    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 10064282
    E.1.2Term Vaginal mucositis
    E.1.2System Organ Class 100000004872
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10028130
    E.1.2Term Mucositis oral
    E.1.2System Organ Class 100000004856
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10065721
    E.1.2Term Anal mucositis
    E.1.2System Organ Class 100000004856
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10028127
    E.1.2Term Mucositis
    E.1.2System Organ Class 100000004867
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10065881
    E.1.2Term Pharyngeal mucositis
    E.1.2System Organ Class 100000004855
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of the trial is to evaluate the effectiveness of folic acid supplement versus PLACEBO on reducing mucositis (nasal, oral, pharyngeal, anal, or genital) according to CTCAE v. 4.0.

    Mucositis (nasal, oral, pharyngeal, anal, or genital) is often experienced in relation to TKI and mTOR inhibitor treatment of mRCC patients. The present trial will assess whether 12 weeks complementary treatment with folic acid in mRCC-patients receiving TKI- or mTOR inhibitor-treatment and displaying CTCAE mucositis grade ≥2 can reduce the degree of mucositis, compared to PLACEBO.
    Det primære mål ved studiet er at evaluere hvor effektivt folinsyretilskud kan reducere mucositis (nasalt, oralt, pharyngealt, analt eller genitalt) sammenlignet med PLACEBO, ved scoring med CTCAE v. 4.0.

    Mucositis (nasal, oral, pharyngeal, anal eller genital) ses ofte sammen med TKI eller mTOR-hæmmer behandling ved RCC patienter. Dette studie vil undersøge om folinsyretilskud vil mindske mucositisgener hos patienter med mucositis-grad ≥2 scoret med CTCAE, sammenlignet med PLACEBO.
    E.2.2Secondary objectives of the trial
    • To evaluate mucositis according to patient reported outcomes (PRO) by self assessment questionnaire (the NCCN-FKSI-19, and an extended version of the M.D. Anderson Symptom Inventory).
    • To evaluate the median time to effect of study drug according to CTCAE v 4.0 and PRO.
    • To evaluate the frequency of dose reductions in the two groups.
    • To evaluate the frequency of treatment discontinuations in the two groups.
    • To evaluate the frequency of treatment withdrawals in the two groups.
    • To evaluate the frequency and degree of GI adverse events according to CTCAE v 4.0 and PRO.
    • To evaluate the frequency and degree of hand-foot according to CTCAE v 4.0 and PRO.
    • To evaluate the quality of life according to CTCAE v 4.0 and PRO.
    • To evaluate the degree of TKI- and mTOR inhibitor-specific adverse events according to CTCAE v 4.0 and PRO.
    • At evaluere mucositis vha patient-rapportede spørgeskemaundersøgelser (PRO) (NCCN-FKSI-19, og en udvidet version af M.D. Anderson Symptom Inventory).
    • At evaluere den mediane tid til effekt af det undersøgte præparat ifølge CTCAE v 4.0 PRO.
    • At evaluere frekvensen af dosisreduktioner i de to grupper i studiet.
    • At evaluere frekvensen af behandlingspauser i de to grupper i studiet.
    • At evaluere frekvensen af behandlingsskift i de to grupper i studiet.
    • At evaluere frekvensen af gastrointestinale bivirkninger i de to grupper i studiet vha CTCAE v 4.0 and PRO.
    • At evaluere frekvensen af hånd-fod-syndrom i de to grupper i studiet vha CTCAE v 4.0 and PRO.
    • At evaluere livskvaliteten i de to grupper i studiet vha CTCAE v 4.0 and PRO.
    • At evaluere graden af TKI- og mTOR hæmmer-specifikke bivirkninger vha CTCAE v 4.0 and PRO.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patients displaying CTCAE ≥2 mucositis during TKI or mTOR inhibitor treatment.
    2. Signed written informed consent obtained prior to any study specific procedures.
    3. Patient must be willing and able to comply with the protocol.
    4. Age > 18.
    5. Biopsy proven locally advanced or metastatic renal cell carcinoma.
    6. Females with a negative serum pregnancy test unless childbearing potential can be otherwise excluded (postmenopausal, hysterectomy or oophorectomy) and not lactating.
    7. Fertile women of childbearing potential (<2 years after last menstruation) and men must use effective means of contraception (oral contraceptives, intrauterine contraceptive device, barrier method of contraception in conjunction with spermicidal jelly or surgical sterilization).
    8. Karnofsky Performance status > 60%.
    1. Patienter med CTCAE mucositis grad ≥2 under TKI eller mTOR-hæmmer behandling.
    2. Skriftligt samtykke opnået før studiestart.
    3. Patienterne skal være villige og i stand til at følge studieprotokollen.
    4. Alder > 18 år.
    5. Biopsiverificeret lokalt-avanceret eller metastatisk renalcellecarcinom.
    6. Kvinder med negativ graviditetstest, medmindre de ikke er i stand til at få børn (postmenopausale, hysterektomerede eller oophorektomerede) og ikke ammende.
    7. Fertile kvinder og mænd skal bruge effektive kontraceptive midler.
    8. Karnofsky Performance status > 60%.
    E.4Principal exclusion criteria
    Known hypersensitivity to folic acid
    Kendt overfølsomhed for folinsyre.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is change from baseline mocositis score according to CTCAE v. 4.0.
    Degree of CTCAE scored mucositis (oral, pharyngeal, anal, or genital) scored on schedules visits at baseline, day 28, day 56, and day 84 using the Common Terminology Criteria for Adverse Events v. 4.0 (CTCAE). Mean difference in change from baseline will be presented for the two groups, using a mean-comparison test on paired data.
    Det primære endepunkt er ændring fra baseline mucositis score baseret på CTCAE v. 4.0.
    Graden af CTCAE-mucositis (oral, pharyngeal, anal, eller genital) scoret på de planlagte besøg ved baseline, dag 28, dag 56 og dag 84 vha the Common Terminology Criteria for Adverse Events v. 4.0 (CTCAE). Den mediane ændring ifht baseline CTCAE vil blive præsenteret for de to grupper, vha mean-comparison test på parrede data.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Median time to effect of folic acid supplement will be evaluated, this defined as time to CTCAE ≤1 mucositis. Kaplan-Meier analysis of time to reduction of CTCAE mucositis to ≤1 will be performed, together with a P-value based on log-rank test.
    All reported p-values will be 2-sided.
    Den mediane tid til effekt af folinsyretilskud vil blive udregnet, dette defineret som tid til CTCAE ≤1 for mucositis. Kaplan-Meier analyse af tid til reduction i CTCAE mucositis vil blive udregnet sammen med en p-værdi vha log-rank test.
    All rapporterede p-værdier vil være 2-sidede.
    E.5.2Secondary end point(s)
    Change from baseline GI adverse events based on CTCAE v. 4.0 or PRO.
    Change from baseline hand-foot syndrome based on CTCAE v. 4.0 or PRO.
    Change from baseline Quality of Life (QoL) based on CTCAE v. 4.0 or PRO.
    The median time to effect of study drug will be evaluated based on PRO every week of the 12 weeks study period.
    The frequency of dose reductions in the two groups after the 12 week study period will be evaluated.
    The frequency of treatment discontinuations in the two groups after the 12 week study period will be evaluated.
    The frequency of treatment withdrawals in the two groups after the 12 week study period will be evaluated.
    Ændring af gastrointestinale bivirkninger fra baseline baseret på CTCAE v. 4.0 eller PRO.
    Ændringer af hånd-fod-syndrom fra baseline baseret på CTCAE v. 4.0 eller PRO.
    Ændring i livskvalitet fra baseline baseret på PRO.
    Den mediane tid til effekt af det undersøgte stof vil blive evalueret baseret på PRO udført hver uge.
    Frekvensen af dosisreduktioner i de to grupper efter de 12 uger vil blive evalueret.
    Frekvensen af behandlingspauser i de to grupper efter de 12 uger vil blive evalueret.
    Frekvensen af behandlingsskift i de to grupper efter de 12 uger vil blive evalueret.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Median time to effect of folic acid supplement will be calculated, this defined as time to a 2-point reduced mucositis, scored on a scale from 0-10, adapted from the MD Anderson Symptom Inventory. Kaplan-Meier analysis of time to a 2-point reduction in both mucositis, GI adverse events, and hand-foot syndrome will be calculated, together with a P-value based on log-rank test. The median reduction in 0-10 scoring from baseline will be calculated for the two groups.
    Response rates, rates of CTCAE adverse events, rates of dose reductions, rates of discontinuations, and rates of treatment withdrawals will be compared using χ2 or Fisher’s exact test. Quality of life comparisons will be based on Wilcoxon rank sum test.
    All reported p-values will be 2-sided.
    Den mediane tid til effekt af folinsyretilskud vil blive udregnet, dette defineret som tid til en 2-points reduction af mucositis, scoret på en skala fra 0-10, adapteret fra MD Anderson Symptom Inventory. Kaplan-Meier analyse af tid til en 2-points reduction gældende for både mucositis, gastrointestinale bivirkninger og hånd-fod-syndrom vil blive udregnet sammen med en log-rank test p-værdi.
    Responsrater, rater af CTCAE-bivirkninger i øvrigt, rater af dosisreduktioner, behandlingspauser og behandlingsskift vil blive sammenlignet vha χ2 eller Fisher’s exact test. QoL-sammenligninger vil blive baseret på Wilcoxon rank sum test.
    All rapporterede p-værdier vil være 2-sidede.
    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 No
    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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    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 Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    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 concerned3
    E.8.5The trial involves multiple Member States No
    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
    LVLS
    LVLS. Sidste besøg af den sidst inkluderede patient.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned 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: 50
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    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 state100
    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)
    When the trial is finished, patients in the PLACEBO-arm can be offered folic acid supplement, if it have shown effect.
    Når studiet er ovre kan patienterne i PLACEBO-armen blive tilbud folinsyretilskud, hvis det har vist at have effekt.
    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 Decision2016-07-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-06-13
    P. End of Trial
    P.End of Trial StatusOngoing
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