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    Summary
    EudraCT Number:2018-001437-40
    Sponsor's Protocol Code Number:KO-TIP-007
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2019-01-22
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2018-001437-40
    A.3Full title of the trial
    The AIM-HN and SEQ-HN Study: A 2 Cohort, Non-comparative, Pivotal Study Evaluating the Efficacy of Tipifarnib in Patients with Head and Neck Squamous Cell Carcinoma (HNSCC) with HRAS Mutations (AIM-HN) and the Impact of HRAS Mutations on Response to First Line Systemic Therapies for HNSCC (SEQ-HN)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The AIM-HN and SEQ-HN Study: A 2 Cohort Study to Evaluate the Safety and Efficacy of Tipifarnib in Patients with Head and Neck Cancer with HRAS Mutations (Cohort 1) and the Impact of HRAS Mutations on Response to Treatment (Cohort 2)
    A.4.1Sponsor's protocol code numberKO-TIP-007
    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 SponsorKura Oncology, Inc.
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportKura Oncology, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationKura Oncology, Inc.
    B.5.2Functional name of contact pointClinical Trials Mailbox
    B.5.3 Address:
    B.5.3.1Street Address12730 High Bluff Drive, Suite 400
    B.5.3.2Town/ citySan Diego
    B.5.3.3Post codeCA 92130
    B.5.3.4CountryUnited States
    B.5.6E-mailprivacy@kuraoncology.com
    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 nameTipifarnib 300 mg
    D.3.2Product code R115777
    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 INNTipifarnib
    D.3.9.1CAS number 192185-72-1
    D.3.9.2Current sponsor code089408
    D.3.9.3Other descriptive nameTIPIFARNIB
    D.3.9.4EV Substance CodeSUB22236
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number300
    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 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 nameTipifarnib 100 mg
    D.3.2Product code R115777
    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 INNTipifarnib
    D.3.9.1CAS number 192185-72-1
    D.3.9.2Current sponsor code089408
    D.3.9.3Other descriptive nameTIPIFARNIB
    D.3.9.4EV Substance CodeSUB22236
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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
    Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC) with HRAS Mutations
    E.1.1.1Medical condition in easily understood language
    Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC) with HRAS Mutations
    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 PT
    E.1.2Classification code 10063569
    E.1.2Term Metastatic squamous cell carcinoma
    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 objective response rate (ORR) of tipifarnib in subjects with Head and Neck Squamous Cell Carcinoma (HNSCC) with HRAS mutations with a VAF≥20% (High VAF population), as assessed by Independent Review Facility (IRF).
    E.2.2Secondary objectives of the trial
    To determine the objective response rate (ORR) of tipifarnib in subjects with Head and Neck Squamous Cell Carcinoma (HNSCC) with HRAS mutations of any VAF (All VAF population), as assessed by IRF.
    To determine the Duration of Response (DOR) of tipifarnib in subjects with Head and Neck Squamous Cell Carcinoma (HNSCC) with HRAS mutations with a VAF≥20% (High VAF population), as assessed by IRF.
    To determine the Duration of Response (DOR) of tipifarnib in subjects with Head and Neck Squamous Cell Carcinoma (HNSCC) with HRAS mutations of any VAF (All VAF population), as assessed by IRF.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Observational cohort SEQ-HN. Study title:
    The AIM-HN and SEQ-HN Study: A 2 Cohort, Non-comparative, Pivotal Study Evaluating the Efficacy of Tipifarnib in Patients with Head and Neck Squamous Cell Carcinoma (HNSCC) with HRAS Mutations (AIM-HN) and the Impact of HRAS Mutations on Response to First Line Systemic Therapies for HNSCC (SEQ-HN).
    Objective for SEQ-HN study and HRAS mutant population:
    To determine if HRAS mutational status is predictive of ORR on first line systemic treatment in patients with recurrent/metastatic HNSCC.
    To determine if treatment outcomes differ (PFS, DOR) with first line systemic therapy in patients with recurrent/metastatic HNSCC with and without HRAS mutations.
    To describe demographic characteristics in patients with HNSCC with and without HRAS mutations.
    E.3Principal inclusion criteria
    AIM-HN
    1.At least 18 years of age
    2.Histologically confirmed head and neck cancer (oral cavity, pharynx, larynx, sinonasal, nasopharyngeal, or unknown primary) of squamous histology not amenable to local therapy with curative intent (surgery or radiation therapy with or without chemotherapy). Enrollment may proceed with local diagnosis but all subj. must consent to provide tumor tissue for a central pathology review.
    3.Documented treatment failure from most recent prior therapy (e.g. tumor progression, clinical deterioration, or recurrence), and from at least one prior platinum-containing regimen, in any treatment setting. The most recent prior and platinum-based therapy may be the same regimen. Those subj., who, at the judgment of the investigator, are considered clinically unsuitable to receive standard platinum-containing regimen may also be enrolled and the reason for clinical unsuitability recorded. There is no limit on the number of prior lines of therapy.
    4.Known tumor missense HRAS mutation detected by Next Generation Sequencing (NGS) or any other methodology approved by the Sponsor. Variant allele frequency (VAF) needs to be determined and must be available. HRAS status should be assessed on tumor tissue obtained subsequent to the most recent prior therapy so that the most accurate tumor biology is evaluated. If tumor tissue that does not meet this criterion must be used (e.g.risk of new biopsy is too high,patient refuses new biopsy), the investigator should document the reason. Enrollment may proceed with the identification of a missense HRAS mutation using a test preferred by the Investigator and approved by the Sponsor during pre-screening, but all subj. must consent to provide tumor tissue for central HRAS confirmation.
    a) At least 59 per protocol subj. must have a VAF ≥20%
    b) No more than approx. 21 per protocol subj. may have a VAF of <20%.
    5.Measurable disease by RECIST v1.1 that meets the criteria for selection as a target lesion according to RECIST v1.1.
    6.At least 2 weeks or 5 half-lives, whichever is longer, since the last systemic therapy regimen prior to C1D1. Last dose of any prior checkpoint inhibitor therapy must have been administered at least 2 weeks prior to C1D1.
    7.At least 2 weeks since last radiotherapy. Subj. must have recovered from all acute toxicities from radiotherapy.
    8.ECOG perform. status of 0-1.
    9.Acceptable liver function:
    a)Bilirubin less or equal 1.5 times upper limit of normal (x ULN);
    b)AST (SGOT) and ALT (SGPT) less or equal 1.5 x ULN. The subject must meet/continue to meet these criteria at the time of first dosing, as confirmed by analysis within 72 hours of C1D1.
    10.Acceptable renal function with either serum creatinine less or equal 1.5 x ULN or a calculated creatinine clearance ≥ 60 mL/min using the Cockcroft-Gault or Modification of Diet in Renal Disease (MDRD) formulas. The subj. must meet/continue to meet these criteria at the time of first dosing, as confirmed by analysis within 72 hours of C1D1.
    11.Acceptable hematologic status:
    a)ANC ≥ 1000 cells/μL.
    b)Platelet count ≥ 75,000/μL.
    c)Hemoglobin ≥ 8.0 g/dL.
    The subject must meet/continue to meet these criteria at the time of first dosing, as confirmed by review of analysis performed within 72 hours of C1D1.
    12.Female subj. must be:
    a)Of non-child-bearing potential (surgically sterilized or at least 2 years post-menopausal); or
    b)If of child-bearing potential, subj. must use a highly effective method of contraception or sexual abstinence. Both females and male subj. with female partners of child-bearing potential must agree to use a highly effective method of contraception from the first dose of tipifarnib, during tipifarnib treatment, and at least 28 days after last dose of tipifarnib for females and 90 days for males. Female subj. must have a negative serum or urine pregnancy test within 72 hours prior to start of trial medication.
    c)Not breast feeding at any time during the study.
    13.Written and voluntary informed consent understood, signed and dated.
    SEQ-HN
    1.At least 18 years of age
    2.Histologically confirmed head and neck cancer (oral cavity, pharynx, larynx, sinonasal, nasopharyngeal, or unknown primary) of squamous histology.
    3.HRAS wildtype (i.e. have no identified tumor missense HRAS mutation) determined by a test preferred by the Investigator and approved by the Sponsor or through central HRAS testing.
    4.Will or has received at least one systemic anti-cancer therapy for recurrent or metastatic HNSCC for which there is available outcome information in terms of ORR, or can be determined based on the subject’s records. Subj. who have not yet received or completed at least one systemic anti-cancer therapy for recurrent or metastatic HNSCC must consent to the collection of treatment outcome information and additional f-u contact in order to participate in the SEQ-HN portion of the study.
    5.Written and voluntary informed consent understood, signed and dated.
    E.4Principal exclusion criteria
    AIM-HN
    1.Has disease that is suitable for local therapy administered with curative intent.
    2.Histologically confirmed salivary gland, thyroid, (primary) cutaneous squamous or nonsquamous histologies (e.g. mucosal melanoma).
    3.Known additional malignancy that is progressing or requires active treatment (excluding non-melanoma skin cancer, adjuvant hormonal therapy for breast cancer and hormonal treatment for castration sensitive prostate cancer).
    4.Ongoing treatment with an anticancer agent not contemplated in this protocol (excluding adjuvant hormonal therapy for breast cancer and hormonal treatment for castration sensitive prostate cancer).
    5.Prior treatment (at least 1 full treatment cycle) with a farnesyltransferase inhibitor (FTI).
    6.Any use of investigational therapy within 2 weeks of Cycle 1 Day 1(C1D1) or 5 half-lives (whichever is longer).
    Last dose of any prior checkpoint inhibitor therapy must have been administered at least 2 weeks prior to C1D1.
    7.Received treatment for unstable angina within prior year, myocardial infarction within the prior year, cerebro-vascular attack within the prior year, history of New York Heart Association grade III or greater congestive heart failure, or current serious cardiac arrhythmia requiring medication except atrial fibrillation.
    8.Non-tolerable Grade 2 or ≥ Grade 3 neuropathy or evidence of unstable neurological symptoms within 4 weeks of Cycle 1 Day 1. Non-tolerable Grade 2 toxicities are defined as those with moderate symptoms that the subject is not able to endure for the conduct of instrumental activities of daily life or that persists ≥ 7 days.
    9.Major surgery, other than diagnostic surgery, within 2 weeks prior to Cycle 1 Day 1, without complete recovery.
    10.Active, uncontrolled bacterial, viral or fungal infections requiring systemic therapy including known history of infection with human immunodeficiency virus or an active infection with hepatitis B or hepatitis C.
    11.Subjects who have exhibited allergic reactions to tipifarnib or structural compounds similar to tipifarnib or to its excipients. This includes hypersensitivity to imidazoles, such as clotrimazole, ketoconazole, miconazole and others in this drug class. Subjects with hypersensitivity to these agents will be excluded from enrollment.
    12.Required use of concomitant medications classified as strong inhibitors or inducers of cytochrome P450 3A4 (CYP3A4, Table 11) or UDP-glucuronosyltransferase (UGT).
    13.Concomitant disease or condition that could interfere with the conduct of the study or that would, in the opinion of the investigator, pose an unacceptable risk to the subject in this study.
    14.Female subjects who are pregnant or lactating.
    15.Unwillingness or inability to comply with the study protocol for any reason.

    SEQ-HN
    1.Histologically confirmed salivary gland, thyroid, (primary) cutaneous squamous or nonsquamous histologies (e.g. mucosal melanoma).
    2.Concomitant disease or condition that could interfere with the conduct of the study or that would, in the opinion of the investigator, pose an unacceptable risk to the subject in this study.
    3.The subject has legal incapacity or limited legal capacity.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the proportion of high VAF subjects with confirmed Objective Response (OR), defined as either Complete Response (CR) or Partial Response (PR), calculated using the mITT analysis set.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Tumor response assessment visit
    E.5.2Secondary end point(s)
    The proportion of all VAF subjects with confirmed Objective Response (OR), defined as either Complete Response (CR) or Partial Response (PR), calculated using the mITT analysis set.
    The duration of response (DOR) in high VAF subjects, calculated using the mITT analysis set.
    The duration of response (DOR) in all VAF subjects, calculated using the mITT analysis set.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Tumor response assessment visit
    End of response assessment visit
    Follow up visit
    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 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 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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA49
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    Austria
    Belgium
    Denmark
    Germany
    Greece
    Italy
    Korea, Republic of
    Malaysia
    Netherlands
    Norway
    Russian Federation
    Spain
    Taiwan
    Thailand
    Ukraine
    United Kingdom
    United States
    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
    The end of this clinical study is defined as 2 years from enrollment of the last enrolled study subject in AIM-HN. If the last enrolled study subject discontinues treatment within 2 years of study enrollment, the End of Study will occur no earlier than the date of the last enrolled subject’s safety follow-up assessment (End of Treatment visit) performed approximately 30 days after treatment discontinuation or until initiation of another anti-cancer therapy, whichever occurs first.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial 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: 84
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 221
    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 state35
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 130
    F.4.2.2In the whole clinical trial 305
    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
    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 Decision2019-02-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-06-25
    P. End of Trial
    P.End of Trial StatusOngoing
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