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    Summary
    EudraCT Number:2022-003460-24
    Sponsor's Protocol Code Number:82914
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2022-11-21
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2022-003460-24
    A.3Full title of the trial
    Pilot study to determine the intraTUMORal OsImertinib concentration in patients with peritoneal metastasizeD colorectal cancer (TUMOROID study)
    Pilotstudie om de intraTUMORale OsImertinib-concentratie te bepalen bij patiënten met peritoneaal gemetastaseerde colorectale kanker (TUMOROID-studie)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Investigation of the tumor concentrations of the anticancer drug osimertinib in tumor resection material of patients with colorectal cancer.
    Onderzoek naar de tumorconcentraties van het antikankermedicijn osimertinib in tumor operatieweefsel van patienten met darmkanker.
    A.3.2Name or abbreviated title of the trial where available
    TUMOROID
    A.4.1Sponsor's protocol code number82914
    A.5.4Other Identifiers
    Name:PaNaMaNumber:113817
    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 SponsorRadboud University Medical Center
    B.1.3.4CountryNetherlands
    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 supportRadboud University Medical Center
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationRadboud University Medical Center
    B.5.2Functional name of contact pointNielka van Erp
    B.5.3 Address:
    B.5.3.1Street AddressGeert Grooteplein-Zuid 10
    B.5.3.2Town/ cityNijmegen
    B.5.3.3Post code6525 GA
    B.5.3.4CountryNetherlands
    B.5.4Telephone number+31243617744
    B.5.5Fax number+31243668755
    B.5.6E-mailnielka.vanerp@radboudumc.nl
    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 Tagrisso
    D.2.1.1.2Name of the Marketing Authorisation holderAstrazeneca
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    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
    Colorectal cancer
    E.1.1.1Medical condition in easily understood language
    Colorectal cancer
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level PT
    E.1.2Classification code 10061451
    E.1.2Term Colorectal cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    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 intratumoral concentration of osimertinib in peritoneal metastasis upon 2 weeks of treatment of patients who are candidate for CRS-HIPEC treatment (group 1), and in liver metastasis of patients who are candidate for primary liver resection (group 2). These clinical determined intratumoral osimertinib concentrations will be compared with the effective tissue concentrations in PDTOs from PM of CRC from the PDO-CRPM study.
    E.2.2Secondary objectives of the trial
    • To assess inter- and intrapatient variability in intratumoral osimertinib concentrations
    • To measure osimertinib concentration in ascites (if present at surgery) and plasma
    • Correlation between plasma, ascites, healthy tissue and intratumoral concentration
    • To determine differences in intratumoral TKI concentrations between PM and liver metastasis
    • To assess the safety and tolerability of pre-operative osimertinib treatment for 2 weeks in patients who will undergo CRS-HIPEC for PM of CRC (group 1) and in patients who will undergo primary liver resection or liver metastasis of CRC (group 2)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Group 1
    • Diagnosed with PM of CRC
    • Candidate for CRS-HIPEC according to the multidisciplinary gastrointestinal tumor board
    • 18 years or older
    • WHO performance status 0 or 1
    • Adequate haematologic and organ function defined as:
    o ALAT and AST ≤ 5x upper limit of normal (ULN)
    o Alkaline phosphatase ≤ 5x ULN
    o Total bilirubin ≤ 1.5x ULN; ≤ 3x ULN in the presence of documented Gilbert’s Syndrome (unconjugated hyperbilirubinaemia) or liver metastasis
    o Haemoglobin ≥ 5.6 mmol/L
    o Absolute Neutrophil count (ANC) ≥ 1.5 x 10*9/L
    o Platelet count ≥ 100 x 10*9/L
    • Written informed consent
    • Able to swallow oral medication

    Group 2
    • Diagnosed with liver metastasis of CRC
    • Candidate for primary resection of at least one liver metastasis according to the multidisciplinary gastrointestinal tumor board
    • 18 years or older
    • WHO performance status 0 or 1
    • Adequate haematologic and organ function defined as:
    o ALAT and AST ≤ 5x upper limit of normal
    o Alkaline phosphatase ≤ 5x ULN
    o Total bilirubin ≤ 3x ULN
    o Haemoglobin ≥ 5.6 mmol/L
    o Absolute Neutrophil count (ANC) ≥ 1.5 x 10*9/L
    o Platelet count ≥ 100 x 10*9/L
    • Written informed consent
    • Able to swallow oral medication
    E.4Principal exclusion criteria
    • Not fit to undergo surgery
    • Concurrent participation in another clinical trial using any medicinal product
    • The use of concomitant drugs that interact with osimertinib according to the Summary of Product Characteristics (SPC) including:
    o Strong and moderate CYP3A4 inducers
    o St. John’s Wort
    o Substrates of breast cancer resistant protein (BCRP) and P-glycoprotein (P-gp) substrates, including rosuvastatin, fexofenadine, digoxin, dabigatran and aliskiren.
    • An active contraindication for the use of osimertinib or a situation in which use of osimertinib is not recommended according to the SPC
    • Mean resting corrected QT interval (QTc) > 470 msec at screening
    • Medical history of interstitial lung disease (ILD), drug-induced ILD, radiation pneumonitis that requires steroid treatment, or any evidence of clinically active ILD
    • Inability to comply with protocol or study procedures
    • Women who are pregnant, plan to become pregnant or are lactating during the study or for up to 3 months after the last dose of the study drug
    • Substance abuse, medical, psychological or social conditions that may interfere with the subject’s participation in the study or evaluation of the study results
    • Minors or incapacitated subjects
    • Any condition that is unstable or could jeopardize the safety of the subject and their compliance in the study.
    E.5 End points
    E.5.1Primary end point(s)
    Intratumoral osimertinib concentration in peritoneal metastasis and liver metastasis.
    E.5.1.1Timepoint(s) of evaluation of this end point
    At the end of the study period.
    E.5.2Secondary end point(s)
    Intra- and interpatient variability in intratumoral osimertinib concentrations. Relation between osimertinib concentration in ascites, plasma and healthy tissue vs intratumoral osimertinib concentration. Safety and tolerability of pre-operative osimertinib treatment.
    E.5.2.1Timepoint(s) of evaluation of this end point
    At the end of the study period.
    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 No
    E.6.6Pharmacokinetic Yes
    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) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 Yes
    E.8.1.7.1Other trial design description
    Multi-center, non-randomized, interventional pilot study
    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 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 concerned2
    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 years1
    E.8.9.1In the Member State concerned months0
    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: 8
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 2
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state10
    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, patients will follow routine clinical care after trial completion
    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 Decision2022-11-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2023-02-23
    P. End of Trial
    P.End of Trial StatusOngoing
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