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    Summary
    EudraCT Number:2017-004522-14
    Sponsor's Protocol Code Number:CRC2017_02
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2019-01-30
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2017-004522-14
    A.3Full title of the trial
    A phase II trial of the FGFR inhibitor INCB054828 in patients with advanced esophageal-gastric junction (EGJ)/Gastric cancer Trastuzumab Resistant: the FiGhTeR trial
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study on the activity and safety of the FGFR inhibitor drug, INCB054828, in patients with advanced gastric adenocarcinoma, resistant to trastuzumab
    A.3.2Name or abbreviated title of the trial where available
    FiGhTeR Study
    A.4.1Sponsor's protocol code numberCRC2017_02
    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 SponsorCentro Ricerche Cliniche di Verona
    B.1.3.4CountryItaly
    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 supportIncyte Biosciences International Sàrl
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCentro Ricerche Cliniche di Verona
    B.5.2Functional name of contact pointCentro Ricerche Cliniche di Verona
    B.5.3 Address:
    B.5.3.1Street AddressP.le L.A. Scuro 10
    B.5.3.2Town/ cityVerona
    B.5.3.3Post code37134
    B.5.3.4CountryItaly
    B.5.4Telephone number+390458126618
    B.5.5Fax number+390458126669
    B.5.6E-mailstefano.milleri@crc.vr.it
    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 namepemigatinib
    D.3.2Product code INCB054828
    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 INNpemigatinib
    D.3.9.1CAS number 1513857-77-6
    D.3.9.2Current sponsor codeINCB054828
    D.3.9.3Other descriptive nameINCB054828
    D.3.9.4EV Substance CodeSUB183791
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number2 to 4.5
    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 esophageal-gastric junction (EGJ)/Gastric cancer Trastuzumab resistant
    E.1.1.1Medical condition in easily understood language
    patients with advanced gastric adenocarcinoma, resistant to trastuzumab
    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 determine the 12-weeks progression free survival (PFS-12w) rate in patients with advanced EGJ/gastric cancer HER2-positive at diagnosis and progressed to a first line therapy with trastuzumab receiving INCB0544828 as second-line monotherapy.
    E.2.2Secondary objectives of the trial
    Efficacy
    •To determine median progression free survival (PFS) in patient treated with INCB054828 as second line monotherapy.
    •To determine overall survival (OS) in patient treated with INCB054828 as second line monotherapy.
    •To determine disease control rate (DCR), number of patient achieving DC (RC/RP/SD).
    •To determine overall response rate (ORR), including confirmed and unconfirmed, complete and partial response, per Responsive Evaluation Criteria in Solid Tumors (RECIST) 1.1
    Safety
    •To assess immediate mortality and morbidity associated with INCB054828 as second-line monotherapy.
    •To estimate frequency and severity of adverse events associated with INCB054828 as second-line monotherapy. Quality of life and cost
    •To determine changes on QoL (daily life activities, nutritional state and weight loss) in patients treated with INCB054828 as second-line therapy.

    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Exploratory: Conservation of biological samples for future research
    •To collect and bank serial serum and plasma specimens from subjects for future correlative biomarker studies.
    •To collect and bank tumor tissue from subjects prior to treatment and optional on-treatment disease progression for future correlative biomarker studies.
    •To correlate, in particular, FGFR3 expression levels with mPFS.
    E.3Principal inclusion criteria
    •Histologically confirmed advanced or metastatic adenocarcinoma of the stomach and the gastroesophageal junction.
    •Disease progression within 3 months of the last dose of first-line trastuzumab containing therapy.
    •Patients must have performed a fresh biopsy (at least 8-10 slides with >20% tumor content) at the baseline of study enrollment.
    •At least one measurable and evaluable disease site based on response evaluation criteria in solid tumors (RECIST v1.1).
    •Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0-1.
    •Age ≥18, no age upper limit unless patient would be unable to tolerate chemotherapy.
    •An expected survival of more than 3 months.
    •Duration from the last therapy is more than 4 weeks for other cytotoxic agents, operation or radiotherapy.
    •Major organ function has to meet the following criteria
    o Hemoglobin (Hb)>8 g/dL
    o PLT >75 X 109/L
    o ANC >1.5 X 109/L
    •Absence of pregnacy or breastfeeding.
    •Pregnancy test (serum or urine) has to be performed for woman of childbearing age within 7 days before enrolment and the test result must be negative. They shall take appropriate methods for contraception during the study until the 8th week post the last administration of study drug. For men shall agree to take appropriate methods of contraception during the study until the 8th week post the last administration of study drug.
    •Patients must be accessible to follow-up and management in the treatment center.
    •Patient has to voluntarily join the study and sign the Informed Consent Form for the study
    E.4Principal exclusion criteria
    •Current evidence of corneal disorder/keratopathy, including but not limited to bullous/band keratopathy, corneal abrasion, inflammation/ulceration, keratoconjuntivitis etc, confirmed by ophthalmologic examination.
    •Any active malignancies except cured basal cell carcinoma of skin and carcinoma in situ of uterine cervix.
    •Poor-controlled arterial hypertension (sistolic blood pressure >140 mmHg and diastolic blood pressure >90 mmHg) despite standard medical management.
    •Serious cardiovascular disease: II level myocardial ischemia or myocardial infarction, arrhytmia (including QT interval prolongation, for man > 450ms, for woman > 470 ms); III-IV level cardiac function insufficiency, or echocardiography showed that left ventricular ejection fraction (LVEF) < 50%.
    •Positive urinary protein (urine protein detection of 2 or more, or 24 hour urine protein >1.0 g).
    •Total bilirubin ≥ 1.5 × upper limit of normal (ULN; ≥ 2.5 × ULN if Gilbert syndrome or metastatic disease involving liver).
    •AST and ALT > 2.5 × ULN (AST and ALT > 5 × ULN in the presence of liver metastases).
    •Creatinine clearance ≤ 30 mL/min based on Cockroft-Gault
    •Factors that could have an effect on oral medication (such as inability to swallow, chronic diarrhea and intestinal obstruction).
    •Serum phosphate > institutional ULN.
    •Serum calcium outside of the institutional normal range or serum albumin-corrected calcium outside of the institutional normal range when serum albumin is outside of the institutional normal range.
    •History of calcium/phosphate homeostasis disorder.
    •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 and asymptomatic arterial or cartilage/tendon calcification.
    •Current evidence of significant corneal disorder/keratopathy or retinal disorder, confirmed by ophthalmologic examination.
    •Factors of high gastrointestinal bleeding risk, including the following conditions: local active ulcer lesions with positive fecal occult blood test (++); history of black stool, or vomiting blood in the past 2 months; unresected primary lesion in stomach with positive fecal occult blood test (+), ulcerated gastric carcinoma with massive alimentary tract bleeding risk judged by Pis based on gastric endoscopy result.
    •Abnormal Coagulation (INR >1.5 APTT >1.5 UNL), with tendency of bleed.
    E.5 End points
    E.5.1Primary end point(s)
    •12-weeks progression free survival rate, the probability of being progression-free (loco-regional or distant) or death due to any cause at 12-weeks from trial enrollment.
    E.5.1.1Timepoint(s) of evaluation of this end point
    At 12 weeks
    The efficacy evaluations will take place at screening (this will be considered the reference scan), every 2 cycles (every 6 weeks) for the first 4 cycles and subsequently every 3 cycles (every 9 weeks). For patients who stop treatment for reasons other than disease progression, every effort will be made to continue monitoring the disease by radiographic imaging up to 1) initiation of a new anti-tumor therapy, 2) progression of the documented disease, 3) death, or 4) end of the study, whichever occurs first.
    E.5.2Secondary end point(s)
    •OS, time from enrollment to death from any cause. It will be estimated with Kaplan Meier curves.
    •DCR, number percentage of patients achieving DC (RC/RP/SD). It will be calculated as a binary outcome. Exact 95% confidence intervals will be calculated for binary outcomes.
    •Incidence of toxicity gratergreater than grade 4, using Common Terminology Criteria for Adverse Events version 4.0 (time frame every two weeks during treatment). Toxicity evaluation will be enumeration of all major toxicity, with proportions calculated for each.
    E.5.2.1Timepoint(s) of evaluation of this end point
    From enrollment to death
    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 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
    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 months
    E.8.9.1In the Member State concerned days
    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: 12
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 6
    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 Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state18
    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)
    Once a subject has received the last dose of study drug, confirmed disease progression, or starts a new anticancer therapy, the subject moves into the survival follow-up period and should be contacted by telephone, email, or visit at least every 12 weeks to assess for survival status until death.
    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 Decision2019-03-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-05-08
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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