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    Summary
    EudraCT Number:2015-005488-18
    Sponsor's Protocol Code Number:8628-006
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-03-31
    Trial results View 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 number2015-005488-18
    A.3Full title of the trial
    A Phase IB Dose Exploration Trial with MK-8628, a Small Molecule Inhibitor of the Bromodomain and Extra-Terminal (BET) Proteins, in Subjects with Selected Advanced Solid Tumors
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    MK-8628 Solid Tumor Trial
    A.3.2Name or abbreviated title of the trial where available
    MK-8628 Solid Tumor Trial
    A.4.1Sponsor's protocol code number8628-006
    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 SponsorOncoethix GmbH, a wholly owned subsidiary of Merck Sharp & Dohme Corp.
    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 supportOncoethix GmbH, a wholly owned subsidiary of Merck Sharp & Dohme Corp
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationOncoethix GmbH, a wholly owned subsidiary of Merck Sharp & Dohme Corp.
    B.5.2Functional name of contact pointSusan Perez
    B.5.3 Address:
    B.5.3.1Street AddressOne Merck Drive, P.O. Box 100
    B.5.3.2Town/ cityWhitehouse Station, New Jersey
    B.5.3.3Post code08889-0100
    B.5.3.4CountryUnited States
    B.5.4Telephone number+17325941414
    B.5.5Fax number+17325943690
    B.5.6E-mailsusan.perez@merck.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 nameMK-8628 (formerly known as OTX015)
    D.3.2Product code MK-8628 (formerly known as OTX015)
    D.3.4Pharmaceutical form Capsule
    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 INNOTX015
    D.3.9.1CAS number 204587-26-8
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 nameMK-8628 (formerly known as OTX015)
    D.3.2Product code MK-8628 (formerly known as OTX015)
    D.3.4Pharmaceutical form Capsule
    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 INNOTX015
    D.3.9.1CAS number 204587-26-8
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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 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 nameMK-8628 (formerly known as OTX015)
    D.3.2Product code MK-8628 (formerly known as OTX015)
    D.3.4Pharmaceutical form Capsule
    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 INNOTX015
    D.3.9.1CAS number 204587-26-8
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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
    NUT Midline Carcinoma
    Non-Small Cell Lung Cancer
    Triple-Negative Breast Cancer
    Castration-Resistant Prostate Cancer
    E.1.1.1Medical condition in easily understood language
    Advanced Solid Tumors
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level PT
    E.1.2Classification code 10061873
    E.1.2Term Non-small cell lung cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level LLT
    E.1.2Classification code 10076506
    E.1.2Term Castration-resistant prostate cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level PT
    E.1.2Classification code 10006187
    E.1.2Term Breast 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 Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine the recommended phase II dose for single-agent MK-8628 administered orally to subjects with selected solid tumors.
    E.2.2Secondary objectives of the trial
    For single-agent MK-8628 administered orally to subjects with selected solid tumors:
    (1)To assess the safety and tolerability;
    (2)To characterize pharmacokinetic and pharmacodynamic parameters;
    (3)To evaluate antitumor activity using objective response rate, duration of response and disease control rate by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or Prostate Cancer Clinical Trials Working Group (PCWG2) as assessed by investigator radiologic review.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    In order to be eligible for participation in this trial, the subject must:
    1.Have signed informed consent/assent prior to initiation of any study-specific procedures and treatment. For study subjects who are legal minors, the parent or legal guardian must also sign the consent/assent form. The subject may also provide consent/assent for Future Biomedical Research. However, the subject may participate in the main trial without participating in Future Biomedical research.
    2.Have histologically or cytologically confirmed diagnosis of one of the following advanced or metastatic solid tumors for which standard therapy either does not exist or has proven ineffective, intolerable or inacceptable for the subject:
    a)NUT midline carcinoma (NMC)(ectopic expression of NUT protein as determined by IHC and/or detection of BRD-NUT gene translocation as determined by FISH)
    b)Non-small cell lung cancer (NSCLC): all comers without gene rearrangement or mutational restrictions
    c)Triple negative breast cancer (TNBC) defined according to ASCO recommendations
    d)Castration-resistant prostate cancer (CRPC)
    3.Have at least one measurable lesion as per RECIST version 1.1., except for CRPC subjects who may be enrolled with objective evidence of disease as per Prostate Cancer Clinical Trials Working Group (PCWG2) criteria.
    4.For NSCLC, TNBC and CRPC subjects, be age ≥ 18 years at the time of informed consent; for NMC subjects, be age ≥ 16 years at the time of informed consent.
    5.Have a life expectancy ≥ 3 months.
    6.Have an Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) ≤ 1.
    7.Demonstrate adequate organ function (adequate bone marrow reserve, renal and liver function)
    8.Have an interval of ≥ 3 weeks since chemotherapy (≥ 6 weeks for nitrosoureas or mitomycin C), immunotherapy, hormone therapy or any other anticancer therapy (including investigational) or surgical intervention resection, or ≥ 3 half-lives for monoclonal antibodies, or ≥ 5 half-lives for other non-cytotoxic agents (whichever is longer).
    9.CRPC subjects must maintain ongoing androgen deprivation therapy with a gonadotropin releasing hormone (GnRH) analogue, antagonist or orchiectomy providing serum testosterone is < 50 ng/dL (<1.7 nmol/L).
    10.Subjects receiving bisphosphonate or denosumab therapy must be on stable doses for at least 4 weeks before initiating study treatment
    11.Female subjects of childbearing potential must have a negative urine or serum pregnancy test within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
    12.Female subjects of childbearing potential should be willing to use an adequate method of contraception as outlined in section 5.7.3– Contraception, for the course of the study through 60 days after the last dose of study medication. Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject.
    13.Male subjects of childbearing potential must agree to use an adequate method of contraception as outlined in Section 5.7.3 – Contraception, starting with the first dose of trial treatment through 60 days after the last dose of study medication. Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject.
    E.4Principal exclusion criteria
    The subject must be excluded from participating in the trial if the subject:
    1.Has inability to swallow oral medications or presence of a gastrointestinal disorder (e.g. malabsorption) deemed to jeopardize intestinal absorption of MK-8628.
    2.Has persistent grade >1 clinically significant toxicities related to prior antineoplastic therapies (except for alopecia); stable sensory neuropathy ≤ grade 2 National Cancer Institute (NCI)-CTCAE v. 4.0 is accepted.
    3.Has known primary CNS malignancy or symptomatic or untreated CNS metastases.
    4.Has a history of prior or concomitant malignancies (other than excised non-melanoma skin cancer or cured in situ cervical carcinoma) within 3 years of signing informed consent.
    5.Has other serious illness or medical condition, such as active infection, unresolved bowel obstruction, psychiatric disorders, or cerebrovascular accident (within 1 year of study entry).
    6.Has known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies).
    7.Has known active Hepatitis B (e.g. hepatitis B surface antigen [HBsAg] reactive) or Hepatitis C (e.g. hepatitis C viral [HCV] RNA [qualitative] is detected).
    8.Has any of the following cardiac-related conditions:
    a.Congestive heart failure or angina pectoris (except if medically controlled)
    b.Previous history of myocardial infarction (within 1 year of study entry)
    c.Uncontrolled hypertension (defined as systolic blood pressure > 140 mmHg, and/or diastolic blood pressure > 90 mmHg, and not adequately managed by anti-hypertensive medication)
    d.Uncontrolled arrhythmias
    9.Has participated in another clinical trial or treatment with any investigational drug (excluding anticancer treatments) within 30 days prior to study entry.
    10.Has other concomitant anticancer treatment, except the use of anti-androgens in CRPC subjects.
    11.Has concomitant therapy with strong CYP3A4 inhibitors or inducers.
    12.Is currently using anticoagulants (e.g. warfarin, heparin) at therapeutic levels within 7 days prior to the first dose of MK-8628. Low-dose (prophylactic) low molecular weight heparin (LMWH) is permitted.
    13.Has a history or current evidence of any condition, therapy, lab abnormality or other circumstance that might expose the subject to risk by participating in the trial, confound the results of the trial, or interfere with the subject’s participation for the full duration of the trial.
    14.Is pregnant or breast-feeding.
    E.5 End points
    E.5.1Primary end point(s)
    The primary objective of this trial is to determine the recommended phase II dose (RP2D) of MK-8628. Selecting the RP2D will involve a multi-faceted decision taking into account safety, tolerability, early efficacy signal, PK exposure and PD markers. The primary endpoint driving dose selection is the DLT rate, with weight given to the highest DL tolerated (<25% DLT rate). All other facets will be considered supportive. It is important to note that dose selection in this study aims to assess a RP2D range, with other factors aside from those mentioned above, such as target engagement, contributing to refining the dose selection for phase 2. This will be further evaluated in subsequent clinical investigations in either monotherapy or combination trials.
    E.5.1.1Timepoint(s) of evaluation of this end point
    DLTs are monitored continuously during the first cycle of treatment (21 days) for each dose level.
    E.5.2Secondary end point(s)
    1.Secondary Safety Endpoints
    A secondary objective of this trial is to determine the safety and tolerability of MK-8628 across subjects with selected advanced solid tumors (NMC, NSCLC, TNBC and CRPC) included in this trial. Safety will be assessed in subjects who have received MK-8628 by determining the RP2D and quantifying and grading reported Adverse Events (AEs) using Common Terminology Criteria for Adverse Events (CTCAE), Version 4.0. Attribution to drug, time-of-onset, duration of the event, resolution, and any concomitant medications administered will be recorded. AEs to be analyzed include but are not limited to all AEs, events of clinical interest (ECI), serious adverse events (SAE), fatal SAEs, and laboratory changes.
    Pharmacokinetic Endpoints
    Plasma parameters of MK-8628 as appropriate and according to analyses performed (non-compartmental or nonlinear mixed effect modelling) will be determined and may include trough (Cmin) and peak (Cmax) concentrations, time to peak concentration (Tmax), AUC[0-∞], volume of distribution at steady state (Vdss), terminal half-life (t1/2), steady state, and total clearance (CL). PK data for MK-8628 will be interpreted in terms of safety findings and compared with historical data. Incidence and severity of AEs along with PK parameters will be analyzed in relation to the most pertinent biomarker(s), if any.
    Pharmacodynamic Endpoints
    Inhibition of BET proteins by MK-8628 leads to alterations in the transcription of messenger RNA (mRNA) at loci most sensitive to disruption of BET activity. These are considered target genes. Changes in expression, measured via mRNA, of prespecified target genes* will be used as PD biomarkers to assess target engagement of BET proteins by MK-8628. (*Note: the following non-exhaustive list of target genes may be considered for testing: Bcl2, IL7R, and MYC as down-regulated target genes; CSRNP2, HEXIM1, and HIST1H2BK as up-regulated target genes.) A range of PD biomarkers will be explored in surrogate samples from all subjects treated, using appropriate assays to establish target engagement. Rather than rely on gene expression changes in cancer cells, these PD biomarkers will be based on current PD knowledge from translational studies of mouse and human whole blood. Using RNA extracted from whole blood samples collected both prior to and following administration of MK-8628, messenger RNA transcript profiling may be performed to assess gene expression and evaluate whether changes in specific genes or sets of genes may represent a PD biomarker of response. Potential limitations of this assay include patient-to-patient variability and a small effect size of induction or repression upon treatment with MK-8628. Due to these limitations, the PD endpoint is considered to be qualitative given the assay may not be able to differentiate target engagement between the MK-8628 doses examined in this study.
    Secondary Efficacy Endpoints: RECIST or PCWG -based Response Rate
    A secondary efficacy objective of this trial is to evaluate the anti-tumor activity of MK-8628 in subjects with selected advanced solid tumors (NMC, NSCLC, TNBC and CRPC). Secondary efficacy endpoints include (1) Objective Response Rate (ORR), defined as the percentage of subjects who have achieved confirmed complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or Prostate Cancer Clinical Trials Working Group (PCWG2), as assessed by investigator radiologic review; (2) Duration of Response (DOR), defined as the time from first documented evidence of CR or PR until disease progression or death due to any cause, whichever occurs first; and (3) Disease Control Rate (DCR), defined as the percentage of subjects who have achieved stable disease or confirmed CR or confirmed PR according to RECIST v1.1 or PCWG2, by the investigator review.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Secondary Safety Endpoints: AEs are monitored continuously.
    PK Endpoints: Cycle 1 - Day 1; immediately prior to the first dose T0 and 20 min±5min, 1h±10min, 2h15min±10min, 3h15min±10min, 8h±1h, and 12h±2h, Day 8 ±1 days, Day 15 ±2 days, and Day 22 ±3 days.
    Pharmacodynamic Endpoints: Cycle 1 - Day 1: immediately prior to the first dose T0 and 3h15min±10min, 8h±1h, and 12h±2h and Day 8 ±1 day.
    Secondary Efficacy Endpoints: For tumor evaluation, a CT, MRI and/or chest X-ray will be performed on Day 1 ± 3 days of every 2nd cycle A bone scan is mandatory for CRPC subjects and will be performed on Day 1 ± 3 days of every 4th cycle(every 3 months).Prostate Specific Antigen measurements will be performed every 4 cycles on a schedule coinciding with the CRPC subjects’ bone scans.
    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 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 No
    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
    Dose Escalation
    E.7.2Therapeutic exploratory (Phase II) No
    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 Yes
    E.8.5.1Number of sites anticipated in the EEA4
    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
    Belgium
    Canada
    France
    Spain
    Switzerland
    United States
    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 years2
    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 years2
    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 Yes
    F.1.1Number of subjects for this age range: 5
    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) Yes
    F.1.1.6.1Number of subjects for this age range: 5
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 25
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 12
    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 state6
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 24
    F.4.2.2In the whole clinical trial 42
    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 the last treatment administration, subjects will be followed up for safety for 30 days and then until resolution of any AEs. A visit will be performed 30 days(±5 days)after the last MK-8628 intake. In subjects who discontinue study therapy without documented disease progression, continue monitoring their disease status by radiologic imaging every 2 cycles until the start of new anti-cancer treatment, documented disease progression, death, or the end of the study, whichever occurs first.
    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 Decision2016-04-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-07-14
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-04-26
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