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    Summary
    EudraCT Number:2013-001033-40
    Sponsor's Protocol Code Number:VS-6063-202
    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:2013-05-06
    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 number2013-001033-40
    A.3Full title of the trial
    A Phase II Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of VS 6063 in Subjects with Malignant Pleural Mesothelioma
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase II Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of VS 6063 in Subjects with Malignant Pleural Mesothelioma
    A.3.2Name or abbreviated title of the trial where available
    VS-6063 Phase II Mesothelioma study
    A.4.1Sponsor's protocol code numberVS-6063-202
    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 SponsorVerastem 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 supportVerastem Inc
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationTMC Pharma Services Ltd
    B.5.2Functional name of contact pointAllison Gillespie
    B.5.3 Address:
    B.5.3.1Street AddressLodge Farm Barn, Elvetham Park Estate, Fleet Road
    B.5.3.2Town/ cityHartley Wintney, Hampshire
    B.5.3.3Post codeRG27 8AS
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number4401252842255
    B.5.5Fax number4401252842277
    B.5.6E-mailallison.gillespie@tmcpharma.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 Yes
    D.2.5.1Orphan drug designation numberEU/3/13/1132
    D.3 Description of the IMP
    D.3.1Product nameVS-6063
    D.3.2Product code VS-6063
    D.3.4Pharmaceutical form 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 INNVS-6063
    D.3.9.1CAS number 1073160-26-5
    D.3.9.2Current sponsor codeVS-6063
    D.3.9.3Other descriptive nameVS-6063
    D.3.9.4EV Substance CodeSUB121676
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    MPM is a rare but aggressive tumour of the serosal surfaces (specifically the pleura and peritoneum) that is highly invasive and progresses rapidly. The main risk factor is exposure to carcinogenic silicate fibres found in asbestos, although genetic factors may also contribute. Tumours usually arise 30 or more years after exposure, and 80% occur in men.
    E.1.1.1Medical condition in easily understood language
    Malignant pleural mesothelioma
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level PT
    E.1.2Classification code 10059518
    E.1.2Term Pleural mesothelioma malignant
    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 compare the overall survival (OS) in subjects with malignant pleural mesothelioma receiving VS-6063 or placebo.
    • To compare the progression free survival (PFS) in subjects with malignant pleural mesothelioma receiving VS-6063 or placebo.
    E.2.2Secondary objectives of the trial
    Secondary Efficacy Objective
    • To assess Quality of Life (QoL) in subjects treated with VS-6063 or placebo using the Lung Cancer Symptom Scale modified for mesothelioma (LCSS-Meso).
    • To determine the objective response rate (ORR) in subjects receiving VS 6063 or placebo.

    Exploratory Objectives
    • To determine the time to new lesion in subjects receiving VS 6063 or placebo.
    • To evaluate the relationship of VS 6063 pharmacokinetics and outcome.
    • To evaluate the population pharmacokinetics of VS 6063 in subjects with malignant pleural mesothelioma.
    • To collect EuroQol 5-Dimensional Health Questionnaire (EQ-5D) for health economics purposes.

    Safety Objectives
    • To evaluate the safety and tolerability of VS 6063 in subjects with malignant pleural mesothelioma
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Able to understand and give written informed consent and comply with study procedures.
    2) Histologically proven diagnosis of MPM. All subjects must have biopsy material (archival tissue is acceptable) available for immunohistochemistry determination of Merlin status prior to enrollment.
    3) Evaluable disease or measurable disease as assessed by RECIST version 1.1.
    4) Received only one prior chemotherapy regimen consisting of ≥ 4 cycles of pemetrexed/cisplatin or pemetrexed/carboplatin; subjects must have documentation of an ongoing response (confirmed PR or SD) following completion of this regimen. Subjects changing from cisplatin to carboplatin or vice versa within the same course of treatment because of platinum toxicity will be considered to have had first-line chemotherapy. Note: Subjects may have undergone previous surgical resection of their disease providing it was completed prior to initiation of chemotherapy. Refer to Appendix D for additional guidance.
    5) Received last dose of prior chemotherapy within ≤ 6 weeks of first dose of VS-6063.
    6) Have completed baseline quality of life evaluation as assessed by LCSS modified for mesothelioma
    7) Age ≥ 18 years.
    8) Life expectancy ≥ 3 months.
    9) All prior chemotherapy induced toxicities must have resolved to grade ≤ 1 prior to randomization.
    10) Performance status according to Karnofsky Performance Scale ≥ 70% (after palliative measures such as pleural drainage).
    11) Corrected QT interval (QTc) < 470 ms (as calculated by the Fridericia correction formula).
    12) Adequate bone marrow function (hemoglobin ≥ 9.0 g/dL; platelets ≥ 100 x 109/L; absolute neutrophil count ≥ 1.5 x 109/L) without the use of hematopoietic growth factors.
    13) Adequate renal function (creatinine ≤1.5 x ULN [upper limit of normal] and/or glomerular filtration rate of ≥ 50mL/min).
    14) Adequate hepatic function (total bilirubin ≤1.5 x ULN; aspartate transaminase and alanine transaminase ≤ 2.5x ULN).
    15) Men and women of childbearing potential must agree to use adequate contraception (double barrier birth control) for the duration of study therapy and for 3 months after the last dose of VS 6063.
    E.4Principal exclusion criteria
    1) Currently enrolled in (or completed within 30 days before study drug administration) another investigational drug study.
    2) Gastrointestinal (GI) condition that could interfere with the swallowing or absorption of study drug.
    3) History of upper GI bleeding, ulceration, or perforation within 12 months prior to the first dose of study drug.
    4) Known history of Gilbert’s Syndrome.
    5) Known history of stroke or cerebrovascular accident within 6 months prior to the first dose of study drug.
    6) Subjects with known infection with human immunodeficiency virus or Acquired Immune Deficiency Syndrome (AIDS) (testing not required).
    7) Subjects with known infection with hepatitis A, B or C virus (testing not required).
    8) Any evidence of serious active infections.
    9) Major surgery within 28 days prior to the first dose of study drug.
    10) Uncontrolled or severe concurrent medical condition (including uncontrolled brain metastases). Stable brain metastases either treated or being treated with a stable dose of steroids and/or anticonvulsants (no dose change within 28 days prior to the first dose of study drug), will be allowed.
    11) Uncontrolled or severe cardiovascular disease, including myocardial infarct or unstable angina within 6 months prior to study treatment, New York Heart Association (NYHA) Class II or greater congestive heart failure, serious arrhythmias requiring medication for treatment, clinically significant pericardial disease, or cardiac amyloidosis.
    12) Known history of malignant hypertension.
    13) Psychiatric illness or social situations that would limit compliance with study requirements.
    14) History of another invasive malignancy in the last 5 years. Adequately treated non-invasive, non-melanoma skin cancers as well as in situ carcinoma of the cervix within the last 5 years will be allowed.
    15) Prior treatment with a focal adhesion kinase (FAK) inhibitor.
    16) Women who are pregnant or breastfeeding.
    E.5 End points
    E.5.1Primary end point(s)
    Primary Endpoints:
    1) Overall Survival
    For all subjects, OS will be calculated from the date of randomization to the date of death. Subjects who are still alive at the time point of analyses, or who dropout prior to study end, will be censored at the day they were last known to be alive. If the sample is not enriched, the HR and 95% CI for treatment group will be estimated from a stratified Cox proportional hazards model overall and within randomization strata. In the case of enrichment, the HR and 95% CI for treatment group will be estimated from a Cox proportional hazards model including Merlin-negative subjects only. The adequacy of the model will be evaluated, including an assessment of the proportional hazards assumption.
    2) Progression free survival
    For all subjects, PFS will be calculated from the date of randomization to the earliest date of CT scan with a central reading documenting relapse, date of other unambiguous indicator of disease development, or date of death. The primary analysis of PFS will be based on the stratified log-rank test, and will use Kaplan-Meier estimation methods for estimation of summary statistics. P-values will be computed by combining results from the initial and primary PFS analysis as described in Section 11.2.3. of the Protocol. Subjects who have no documented relapse and are still alive prior to the final efficacy analyses, who dropout prior to study completion, or who have nonevaluable disease will be censored at the date of the last radiological evidence documenting absence of relapse. The HR with respect to relapse or death will also be calculated using Cox’s proportional hazard model, stratified by randomization strata. Additional exploratory Cox models will be used to determine the effect of other potential prognostic factors, including at least gender, age, histology, and prior surgery.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Subjects will be treated until disease progression (as confirmed by central review) or other discontinuation criteria are met.

    Each subject’s active participation in this study will last a minimum of approximately 3.5 months, including:
    • Up to 28 day screening period.
    • At least 6 weeks of study treatment. However, subjects may continue to receive additional study treatment until disease progression has been documented or other discontinuation criteria have been met.
    • Follow-up visit performed 30 days after the last dose of study drug.
    Following documentation of non-death related progression, all subjects will be followed for survival by telephone contact every 2 months until death or the close of the study.
    E.5.2Secondary end point(s)
    Secondary Efficacy Endpoints:
    1) Quality of Life using the Lung Cancer Symptom Scale (LCSS) modified for mesothelioma
    2) Objective Response Rate

    Exploratory Endpoints:
    1) Time to New Lesion
    2) EQ-5D Health Assessment Questionnaire
    E.5.2.1Timepoint(s) of evaluation of this end point
    Subjects will be treated until disease progression (as confirmed by central review) or other discontinuation criteria are met.

    Each subject’s active participation in this study will last a minimum of approximately 3.5 months, including:
    • Up to 28 day screening period.
    • At least 6 weeks of study treatment. However, subjects may continue to receive additional study treatment until disease progression has been documented or other discontinuation criteria have been met.
    • Follow-up visit performed 30 days after the last dose of study drug.
    Following documentation of non-death related progression, all subjects will be followed for survival by telephone contact every 2 months until death or the close of the study.
    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 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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    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 Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA50
    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
    Belgium
    Canada
    Denmark
    France
    Italy
    Japan
    Korea, Republic of
    Netherlands
    New Zealand
    Norway
    Poland
    South Africa
    Spain
    Sweden
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    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 years3
    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: 150
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 250
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 250
    F.4.2.2In the whole clinical trial 400
    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)
    Expected normal treatment for the 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 Decision2013-06-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-09-23
    P. End of Trial
    P.End of Trial StatusCompleted
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