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    The EU Clinical Trials Register currently displays   43209   clinical trials with a EudraCT protocol, of which   7151   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2021-006276-16
    Sponsor's Protocol Code Number:CTRIAL-IE-20-27
    National Competent Authority:Ireland - HPRA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2022-01-11
    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 ConcernedIreland - HPRA
    A.2EudraCT number2021-006276-16
    A.3Full title of the trial
    PaTcH Trial: A phase 2 study to explore primary and emerging
    resistance mechanisms in patients with metastatic refractory pancreatic cancer treated with trametinib and hydroxychloroquine.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A phase 2 clinical research study to examine if trametinib and hydroxychloroquine will improve outcomes for patients with advanced pancreatic cancer.
    A.3.2Name or abbreviated title of the trial where available
    PaTcH Trial.
    A.4.1Sponsor's protocol code numberCTRIAL-IE-20-27
    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 SponsorCancer Trials Ireland
    B.1.3.4CountryIreland
    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 supportCancer Trials Ireland
    B.4.2CountryIreland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCancer Trials Ireland
    B.5.2Functional name of contact pointHead of Clinical Operations
    B.5.3 Address:
    B.5.3.1Street AddressRCSI House, 121 St. Stephen's Green
    B.5.3.2Town/ cityDublin
    B.5.3.3Post codeD02 H903
    B.5.3.4CountryIreland
    B.5.4Telephone number+35316677211
    B.5.6E-mailinfo@cancertrials.ie
    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 Mekinist®
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Europharm Limited
    D.2.1.2Country which granted the Marketing AuthorisationIreland
    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 nameTrametinib
    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.3.8INN - Proposed INNTrametinib
    D.3.9.3Other descriptive nameTRAMETINIB DIMETHYL SULFOXIDE
    D.3.9.4EV Substance CodeSUB167251
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number0.5 to 2
    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.IMP: 2
    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 Hydroxychloroquine sulfate
    D.2.1.1.2Name of the Marketing Authorisation holderAccord-UK Ltd
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 nameHydroxychloroquine sulfate
    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.3.8INN - Proposed INNHydroxychloroquine sulfate
    D.3.9.3Other descriptive nameHydroxychloroquine sulfate
    D.3.9.4EV Substance CodeSUB02587MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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
    Metastatic refractory pancreatic cancer.
    E.1.1.1Medical condition in easily understood language
    Advanced pancreatic cancer.
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10033605
    E.1.2Term Pancreatic cancer metastatic
    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
    To determine the 12-week progression free survival (PFS) of trametinib and hydroxychloroquine in patients with metastatic refractory pancreatic cancer.
    E.2.2Secondary objectives of the trial
    SECONDARY OBJECTIVES:
    1. To determine the response rate, duration of response& overall survival in patients with metastatic refractory pancreatic cancer treated with trametinib & hydroxychloroquine.
    2. To assess the safety & tolerability of this regimen.

    EXPLORATORY/TRANSLATIONAL OBJECTIVES:
    1. To establish patient-derived organoids from biopsies of patients with pancreatic cancer being treated with trametinib & hydroxychloroquine before treatment & on treatment.
    2. To assess efficiency of treatment&potential emerging resistance mechanisms in patient derived organoid cultures from patients with pancreatic cancer treated with trametinib &hydroxychloroquine.
    3. To deeply characterise resistance mechanisms&design &test potential rescue therapies in patient-derived organoid cultures from patients with pancreatic cancer treated with trametinib&hydroxychloroquine.
    4. To further refine the computational resistance models using new methods of multi-omics data integration.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    The sub-study is part of the main protocol.
    This sub-study will include a translational component exploring primary and emerging resistance mechanisms to treatment with trametinib and hydroxychloroquine.

    The aims of the sub-study are as follows:

    Aim 1: Establish organoids.
    Aim 2: Assessment of mechanisms of emerging resistance.
    Aim 3: Evaluating potential rescue of resistance.
    Aim 4: Refinement of resistance models.
    E.3Principal inclusion criteria
    1. Patients must have pathologically confirmed advanced metastatic pancreatic adenocarcinoma or poorly differentiated pancreatic adenocarcinoma that is amenable to tumour biopsy.

    2. Patients have received at least one line of systemic therapy for metastatic disease and not be amenable to surgical resection.

    3. Patients must have measurable disease by RECIST 1.1 criteria.

    4. Age ≥18 years.

    5. ECOG performance status ≤ 1

    6. Patients must have normal organ and marrow function as defined below:

    a. Serum creatinine ≤ 1.5 x ULN.

    b. Adequate hepatic function defined by:
    o total bilirubin level ≤ 1.5 × ULN,
    o an AST, level ≤ 2.5 × ULN, and an ALT level ≤ 2.5 × ULN (or, for subjects with documented metastatic disease to the liver, AST and ALT levels ≤ 5 × ULN)

    c. Hematological eligibility parameters:
    o Absolute Neutrophil count ≥ 1.5 x 10^9/L
    o Platelet count ≥100 x10^9/L
    o Hemoglobin ≥ 9 g/dL

    7. Ability of subject to understand and the willingness to sign a written informed consent document.

    8. Women of child-bearing potential or sexually active males must agree to use highly effective contraceptive measures. This applies from starting treatment until at least 16 weeks after the last study drug administration. The investigator or a designated associate is required to advise the patient how to achieve an adequate birth control. Highly effective contraception is defined in the study as methods that achieve a failure rate of less than 1% per year when used
    consistently and correctly. Such methods include:

    I. Combined (oestrogen and progestogen containing) hormonal contraception
    associated with inhibition of ovulation (oral, intravaginal, transdermal).
    II. Progestogen-only hormonal contraception associated with inhibition of ovulation
    (oral, injectable and implantable).
    III. Intrauterine device (IUD).
    IV. Intrauterine hormone-releasing system (IUS).
    V. Bilateral tubal occlusion.
    VI. Successfully vasectomised partner.
    VII. Sexual abstinence.
    E.4Principal exclusion criteria
    1. Persisting toxicity related to prior therapy (CTCAE Grade > 1); however alopecia, sensory neuropathy Grade ≤ 2, or other Grade ≤2 AEs not constituting a safety risk based on
    investigator's judgment are acceptable.

    2. Prior treatment with a MEK inhibitor.

    3. Known history of testing positive for Human Immunodeficiency Virus (HIV) or known acquired
    immunodeficiency syndrome.

    4. Any significant disease that, in the opinion of the investigator, may impair the patient’s tolerance of study treatment.

    5. Patients who are receiving any other investigational agents within 28 days before start of study treatment.

    6. Prior organ transplantation including allogenic stem-cell transplantation.

    7. Patients with known central nervous system metastases.

    8. Active uncontrolled infection, requiring systemic therapy.

    9. Clinically significant (i.e., active) cardiovascular disease: cerebral vascular accident/stroke (< 6 months prior to enrollment), myocardial infarction (< 6 months prior to enrollment), unstable angina, congestive heart failure (≥ New York Heart Association Classification Class II), or serious
    cardiac arrhythmia requiring medication.

    10. Severe left ventricular dysfunction as defined by ejection fraction < 45%.

    11. Other severe acute or chronic medical conditions including colitis, inflammatory bowel disease, pneumonitis, pulmonary fibrosis or psychiatric conditions including recent (within the past year) or active suicidal ideation or behaviour; or laboratory abnormalities that may increase the risk associated with study participation or study treatment administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study.

    12. Known maculopathy of the eye.

    13. Known history or current evidence of retinal vein occlusion (RVO) or current risk factors for RVO (e.g. uncontrolled glaucoma or ocular hypertension, history of hyperviscosity or hypercoagulability syndromes).

    14. Screening corrected QT interval by Fridericia (QTcF) > 500 msec.

    15. Pregnant women and breastfeeding mothers are excluded due to unknown impact on embryos or infants.

    16. Known prior severe hypersensitivity to investigational products or any component in its formulation.

    17. Concurrent use of medicines known to induce retinal toxicity (e.g. tamoxifen) or QT interval prolonging agents.

    18. Known congenital or documented acquired QT prolongation.

    19. Uncorrected hypokalemia and/or hypomagnesemia.
    E.5 End points
    E.5.1Primary end point(s)
    Anti-tumour efficacy of treatment will be primarily measured as 12-week progression free survival (PFS): that is, the percentage of patients free of progression at 12 weeks from starting treatment into the study as determined by radiographic disease assessments per RECIST version 1.1. Planned efficacy assessments will occur by Computed Tomography Thorax, Abdomen and Pelvis (CT TAP) at baseline, 6 weeks, 12 weeks post starting treatment and then q-8 weekly until disease progression or consent withdrawal.
    E.5.1.1Timepoint(s) of evaluation of this end point
    An Interim Analysis will be performed after the first 10 patients have been enrolled and evaluated for radiological/clinical progression.

    A Final Analysis will be performed when the trial has been completed.
    E.5.2Secondary end point(s)
    SECONDARY ENDPOINTS:

    1. Confirmed tumour response rate and duration of response as assessed by RECIST version 1.1.

    2. Overall survival

    3. To evaluate the safety and tolerability of this regimen as measured by incidence of adverse events reported and toxicity evaluation as per the National Cancer Institute’s Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0.

    EXPLORATORY ENDPOINTS

    1. To establish patient-derived organoids from biopsies of patients with pancreatic cancer being treated with trametinib and hydroxychloroquine before treatment and on treatment.

    2. To assess efficiency of treatment and potential emerging resistance mechanisms in patient-derived organoid cultures from patients with pancreatic cancer treated with trametinib and hydroxychloroquine.

    3. To deeply characterise resistance mechanisms and design and test potential rescue therapies in patient-derived organoid cultures from patients with pancreatic cancer treated with trametinib and hydroxychloroquine.

    4. To further refine the computational resistance models using new methods of multi-omics data integration.
    E.5.2.1Timepoint(s) of evaluation of this end point
    A risk assessment will be performed at the beginning of the study and reviewed on an ongoing basis.

    The study will be reviewed on a regular basis by the Cancer Trials Ireland Safety Monitoring Committee while patients are on treatment or in the immediate follow-up period (30 days post last dose).

    The analysis of the secondary exploratory endpoints will be performed after the required number of tissue samples are available.

    An Interim Analysis will be performed after the first 10 patients have been enrolled and evaluated for radiological/clinical progression.

    A Final Analysis will be performed when the trial has been completed.
    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 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 Yes
    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 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
    The end of study is defined as whichever occurs first, when all enrolled patients have completed treatment and follow-up on the study or when the last patient registered has been followed up for 1 year from registration.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months6
    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: 11
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 11
    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 state22
    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)
    After their participation in the trial has ended, patients will receive the expected normal treatment for their condition.
    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 Decision2022-03-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-03-09
    P. End of Trial
    P.End of Trial StatusOngoing
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