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    Summary
    EudraCT Number:2019-004987-23
    Sponsor's Protocol Code Number:RAS-Triplet
    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:2020-04-21
    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 number2019-004987-23
    A.3Full title of the trial
    A Dose-Escalating Phase I/II Study in Patients with RAS-Mutated Metastatic Colorectal Cancer to Investigate Safety and Clinical Activity of the Triple Combination of: MEK-inhibitor binimetinib, Pan-EGFR inhibitor lapatinib and the Microtubule Targeting Agent (MTA) vinorelbine.
    Een dosis-escalatie fase I/II studie bij patiënten met RAS-gemuteerde, gemetastaseerde colorectale kanker om de veiligheid en klinische activiteit van de drievoudige combinatie te onderzoeken van MEK-remmer binimetinib, pan-EGFR-remmer lapatinib en de microtuble targeting agent (MTA) vinorelbine.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    RASTRIC-trial: investigating the safety and efficacy of a new three drug treatment combination for RAS-mutated metastastic colorectal cancer.
    RASTRIC-studie: onderzoek naar de veiligheid en effectiviteit van een nieuwe behandeling met drie middelen voor RAS-gemuteerde uitgezaaide dikke darmkanker.
    A.3.2Name or abbreviated title of the trial where available
    RASTRIC Trial
    RASTRIC studie
    A.4.1Sponsor's protocol code numberRAS-Triplet
    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 SponsorUMC Utrecht
    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 supportONCODE institute
    B.4.2CountryNetherlands
    B.4.1Name of organisation providing supportUMC Utrecht
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUMC Utrecht
    B.5.2Functional name of contact pointtrial manager
    B.5.3 Address:
    B.5.3.1Street AddressHeidelberglaan 100, Postbus 85500
    B.5.3.2Town/ cityUtrecht
    B.5.3.3Post code3508 GA
    B.5.3.4CountryNetherlands
    B.5.4Telephone number+31(0)887556263
    B.5.6E-mailoncology-trials-secretariat@umcutrecht.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 Mektovi
    D.2.1.1.2Name of the Marketing Authorisation holderPierre Fabre Medicament
    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.3.1Product nameMektovi
    D.3.2Product code EMEA/H/C/004579
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.11 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 Tyverb
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Europharm Limited
    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.3.1Product nameTyverb
    D.3.2Product code EMEA/H/C/000795
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.11 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: 3
    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 vinorelbine
    D.2.1.1.2Name of the Marketing Authorisation holderAurobindo
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 namevinorelbine
    D.3.2Product code RVG 35294
    D.3.4Pharmaceutical form Concentrate and solvent for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNVINORELBINE TARTRATE
    D.3.9.3Other descriptive namevinorelbine
    D.3.9.4EV Substance CodeSUB20777
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10 mg/ml
    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
    colorectaal carcinoom
    E.1.1.1Medical condition in easily understood language
    colorectal cancer
    dikkedarmkanker
    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
    Phase I
    The main objective of the phase I part is to determine safety and the recommended phase II dose (RP2D) of the triple combination.

    Phase II
    The main objective of the phase II part is to determine efficacy of the triplet combination defined by objective response rate according to RECIST 1.1.

    E.2.2Secondary objectives of the trial
    Secondary Objectives:

    Phase I dose escalation
    - To describe safety and tolerability of the triplet combination
    - To describe the pharmacokinetic profile of vinorelbine, lapatinib and binimetinib.


    Phase II
    - To describe safety and tolerability of the triplet combination
    - To evaluate additional antitumor activity parameters including clinical benefit rate and progression-free survival.
    - To describe the pharmacokinetic profile of vinorelbine, lapatinib and binimetinib.


    Exploratory objectives:
    Exploratory pharmacodynamics (inhibition of downstream targets and apoptosis) and the use of organoids as predictive biomarker will be assessed.
    Furthermore a sub study will be performed on the correlation between cardiotoxicity (LVEF decline) and the release of cardiac biomarkers. Finally, blood samples will be stored to allow the analyses of additional biomarkers including circulating tumor DNA (ctDNA).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Histological or cytological proof of CRC.
    2. After failure of a minimum of 2 lines of standard of care regimens. Prior lines of treatment must include: a minimum of 2 lines of prior systemic treatment for metastatic disease, including at least fluoropyrimidine, oxaliplatin and irinotecan based treatment (unless contra-indications for either oxaliplatin and/or irinotecan). Adjuvant treatment completed < 6 months before development of metastatic disease will be counted as 1st line for metastatic disease.
    3. Written documentation of a known pathogenic RAS mutation.
    4. Age  18 years.
    5. Able and willing to give written informed consent.
    6. Measurable disease according to RECIST 1.1
    7. WHO performance status of 0 or 1.
    8. Able to swallow and retain orally administered medications and does not have clinically significant gastrointestinal abnormalities that may alter absorption (e.g. malabsorption syndrome or major resection of the stomach or bowel)
    9. Able and willing to undergo blood sampling.
    10. Able and willing to undergo a tumor biopsy prior to start and after two weeks on therapy. Tumor biopsy should be histological. Cytological biopsies are not accepted.
    11. All toxicities related to prior treatment should have resolved to CTCAE grade 1 or less (excluding alopecia)
    12. Life expectancy  3 months allowing adequate follow up of toxicity evaluation and antitumor activity.
    13. Women of childbearing potential must have a negative serum pregnancy test within 14 days prior to registration and agree to use effective contraception, throughout the treatment period, and for 4 months after the last dose of study treatment.
    14. Adequate organ functions as defined by table 2.


    Table 2 Definitions for adequate baseline organ function
    Absolute neutrophil count ≥ 1.5 x 109/L
    Hemoglobin ≥ 6.0 mmol/L
    Platelets ≥ 100 x 109/L
    PT/INR and aPTT within normal limits (unless anti-coagulant treatment)
    Hepatic:
    Total bilirubin ≤ 1.5 x ULN
    AST and ALT ≤ 2.5 x ULN
    Renal:
    Serum creatinine ≤ 1.5 x ULN
    Or Calculated creatinine clearance
    by Cockcroft-Gault formula: ≥ 50 mL/min

    Cardiac:
    Left Ventricular Ejection Fraction (LVEF) by ECHO or MUGA ≥ 50%

    E.4Principal exclusion criteria
    1. Any treatment with investigational drugs within 30 days or 5 half-lives prior to receiving the first dose of investigational treatment.
    2. History of another malignancy. Exceptions: Patients who have been disease-free for at least 3 years after treatment with curative intent, or patients with a history of completely resected non-melanoma skin cancer, in situ carcinoma of the cervix and/or patients with indolent completely resected second malignancies are eligible.
    3. Symptomatic or untreated leptomeningeal disease.
    4. Symptomatic brain metastases. Patients previously treated or untreated for these conditions that are asymptomatic in the absence of corticosteroid and anticonvulsant therapy (for at least 6 weeks) are allowed to enrol. Radiotherapy for brain metastases must have been completed at least 6 weeks prior to start of study treatment. Brain metastasis must be stable with verification by imaging (e.g. brain MRI or CT completed at screening demonstrating no current evidence of progressive brain metastases). Patients are not permitted to receive anti-epileptic drugs or corticosteroids.
    5. Patients previously treated with combination treatment of drugs known to interfere with EGFR, HER-2, HER-3, HER-4 or MAPK- and PI3K-pathway components, including inhibitors of PTEN, PI3K, AKT, mTOR, BRAF, MEK and ERK. Single agent targeted therapies interfering with these pathways are allowed.
    6. History of interstitial lung disease or pneumonitis
    7. Women who are pregnant or breast feeding.
    8. Unreliable contraceptive methods. Both men and women enrolled in this trial must agree to use a reliable contraceptive method throughout the study (adequate contraceptive methods are: condom, sterilization, other barrier contraceptive measures preferably in combination with condoms).
    9. Radio-, immuno- or chemotherapy within the last 4 weeks prior to receiving the first dose of investigational treatment. Palliative radiation (1x 8Gy) is allowed.
    10. Patients who have undergone any major surgery within the last 3 weeks prior to starting study drug or who would not have fully recovered from previous surgery.
    11. Uncontrolled infectious disease or known Human Immunodeficiency Virus HIV-1 or HIV-2 type patients.
    12. Patients with known, active, hepatitis B (HBV) or C virus (HCV).
    13. Patients with retinal degenerative disease (hereditary retinal degeneration or age-related macular degeneration), or with a history of uveitis, retinal vein occlusion, central serous retinopathy, or retinal detachment.
    14. Patients with left ventricular ejection fraction (LVEF) < 50%.
    15. History or evidence of cardiovascular risk including any of the following:
    • A QT interval corrected for heart rate using the Bazett’s formula (QTcB; Appendix X) 480 msec;
    • History or evidence of current clinically significant uncontrolled arrhythmias. Exception: Subjects with controlled atrial fibrillation for >30 days prior to randomization are eligible.
    • History of acute coronary syndromes (including myocardial infarction and unstable angina), coronary angioplasty, or stenting within 6 months prior to randomization.
    • History of or evidence of current congestive heart failure ≥ Class class II congestive heart failure as defined by the New York Heart Association.
    • Treatment refractory hypertension defined as a blood pressure of systolic > 150 mmHg and/or diastolic > 90 mm Hg which cannot be controlled by one maximally dosed anti-hypertensive therapy;
    • Patients with intra-cardiac defibrillators;
    16. Other severe, acute, or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration or that may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for the study.
    17. Known hypersensitivity to one of the study drugs.
    18. Use of any live vaccines against infectious diseases (e.g. varicella, pneumococcus or yellow fever) within 4 weeks of initiation of study treatment.
    19. Use of prohibited co-medication or herbs and inability to discontinue this treatment or switch to an alternative drug at least 7 days prior to starting study treatment. (see paragraph 8.8.1.
    E.5 End points
    E.5.1Primary end point(s)
    For the phase I dose-escalation trial:
    The primary endpoint is the incidence of DLTs leading to a RP2D. The RP2D of the triplet will be the MTD which is defined as the dose level that can be given to 6 subjects such that not more than 1 subject experiences a DLT.

    For the phase II trial:
    The primary endpoint is best overall response (OR), defined as complete response (CR) + partial response (PR) within 6 months, based on RECIST 1.1.
    E.5.1.1Timepoint(s) of evaluation of this end point
    - evaluation of DLTs during first cycle (= 21 days)
    - determining respons based on CT-scans every 6 weeks.
    E.5.2Secondary end point(s)
    Secondary study endpoints
    • Safety and tolerability assessed by:
    o Incidence and severity of adverse events (AEs) graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 5.0
    o Incidence of dose interruptions, dose modifications and discontinuations due to AEs
    • The pharmacokinetic (PK) profile of vinorelbine, lapatinib and binimetinib.
    • Clinical benefit, defined as CR + PR + stable disease (SD) for at least 6 months.
    • Progression-free survival (PFS), defined as the time from the date of randomization until the date of the investigator-assessed radiological disease progression (RECIST 1.1) or death due to any cause.


    Exploratory endpoints
    The following exploratory endpoints will be evaluated:
    • Predictive value of organoid cultures at baseline for response to therapy.
    • To explore the pharmacodynamics (PD) profile of the lapatinib-binimetinib-vinorelbine combination as measured by expression levels of downstream targets (e.g. pERK, pMEK) and markers of apoptosis (e.g. caspase-3) in tumor tissue taken prior to treatment, while on treatment and upon progression.
    • To correlate the PK with the PD and response.
    • To evaluate the treatment response in different clinical subgroups including different types of RASmutation and left versus right sided primary tumors.
    • To correlate cardiac biomarkers with the occurrence of a decline in LVEF
    • Circulating biomarkers may be measured, including but not limited to ctDNA in order to predict response/resistance, investigate the mechanisms of resistance by evaluating the development of novel mutations in the ctDNA.
    E.5.2.1Timepoint(s) of evaluation of this end point
    - evaluation of adverse events, continuous
    - determining respons and progression-free survival based on CT-scans every 6 weeks.
    - determining the pharmacokinetic profile in the first week of administration
    - determining the pharmacodynamics based on tumor and skin biopsies obtained at baseline and on cycle 1 day 12.
    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 Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic Yes
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    evaluation of a novel combination of drugs
    onderzoek van een nieuwe combinatie van geneesmiddelen
    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 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
    last visit last subject
    laatste visite van de laatste patient
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months36
    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: 26
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 state36
    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
    geen
    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 Decision2020-04-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-05-22
    P. End of Trial
    P.End of Trial StatusOngoing
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