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    Summary
    EudraCT Number:2012-002957-42
    Sponsor's Protocol Code Number:EMR200592-001
    National Competent Authority:Slovakia - SIDC (Slovak)
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-05-21
    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 ConcernedSlovakia - SIDC (Slovak)
    A.2EudraCT number2012-002957-42
    A.3Full title of the trial
    A Randomized, Double-Blind, Phase III Study of the Efficacy and Safety of Gemcitabine in Combination With TH-302 Compared With Gemcitabine in Combination With Placebo in Previously Untreated Subjects With Metastatic or Locally Advanced Unresectable Pancreatic Adenocarcinoma
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical Trial testing TH-302 in combination with gemcitabine in combination in previously untreated patients with pancreatic cancer
    A.4.1Sponsor's protocol code numberEMR200592-001
    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 SponsorMerck KGaA
    B.1.3.4CountryGermany
    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 supportMerck KGaA
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMerck KGaA
    B.5.2Functional name of contact pointCommunication Center
    B.5.3 Address:
    B.5.3.1Street AddressFrankfurter Straße 250
    B.5.3.2Town/ cityDarmstadt
    B.5.3.3Post code64293
    B.5.3.4CountryGermany
    B.5.4Telephone number+496151725200
    B.5.5Fax number+496151722000
    B.5.6E-mailservice@merck.de
    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 nameTH-302
    D.3.2Product code TH-302
    D.3.4Pharmaceutical form Concentrate 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 INNnot available
    D.3.9.1CAS number 918633-87-1
    D.3.9.2Current sponsor codeTH-302
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Locally advanced unresectable pancreatic adenocarcinoma
    E.1.1.1Medical condition in easily understood language
    Advanced Pancreatic Cancer
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.1
    E.1.2Level LLT
    E.1.2Classification code 10033606
    E.1.2Term Pancreatic cancer non-resectable
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of the trial is to evaluate efficacy, as measured by overall survival (OS), of gemcitabine in combination with TH-302 compared to gemcitabine in
    combination with placebo in subjects with previously untreated locally advanced unresectable or metastatic pancreatic adenocarcinoma.
    E.2.2Secondary objectives of the trial
    To assess efficacy with resepct to:
     progression free survival (PFS), and
     objective response (OR) and disease control.
    To assess patient reported outcomes (PROs) with respect to quality of life (QoL) measured with EORTC QLQ-C30 (Version 3) and EQ-5D-5L, and pain measured by a Numerical Rating Scale (NRS).
    To investigate levels of carbohydrate antigen 19-9 (CA19-9),
    To assess the safety and tolerability of gemcitabine in combination with TH-302 compared with gemcitabine in combination with placebo.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - At least 18 years of age.
    - Locally advanced unresectable or metastatic pancreatic ductal adenocarcinoma proven by
    histology or cytology and previously untreated with chemotherapy or systemic therapy
    - Measurable disease (at least one target lesion outside of previous radiation fields) or
    non-measurable disease by RECIST 1.1 criteria (see Appendix III).
    - Documentation of disease progression since any prior therapy.
    - Life expectancy of at least 3 months.
    - Acceptable liver function.
    - Acceptable renal function.
    - Acceptable hematologic status.
    - See protocol for fulll list of inclusion criteria
    E.4Principal exclusion criteria
    1. New York Heart Association (NYHA) Class III or IV congestive heart failure, myocardial
    infarction within 6 months prior to the date of randomization, unstable arrhythmia or
    symptomatic peripheral arterial vascular disease.
    2. Symptomatic ischemic heart disease.
    3. Known brain, leptomeningeal or epidural metastases (unless treated and well controlled for at
    least 3 months).
    4. Previous malignancy other than pancreatic cancer in the last 5 years, except for adequately
    treated non-melanoma skin cancer or pre-invasive cancer of the cervix.
    5. Severe chronic obstructive or other pulmonary disease with hypoxemia
    6. Major surgery, other than diagnostic surgery, ≤28 days prior to the date of randomization.
    Subject must have completely recovered from surgery.
    7. Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy.
    8. Treatment of pancreatic cancer with radiation therapy or surgery ≤28 days prior to the date of
    randomization.
    9. Prior therapy with a hypoxic cytotoxin.
    10. Subjects who participated in an investigational drug or device trial ≤28 days prior to Day 1 of
    the first cycle.
    11. Known infection with HIV, or an active infection with hepatitis B or hepatitis C.
    12. Subjects who have exhibited allergic reactions to a structural compound similar to TH-302 or
    the drug product excipients or to gemcitabine or its excipients.
    13. See protocol for full list of exclusion criteria.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is Overall Survival (OS) time.
    E.5.1.1Timepoint(s) of evaluation of this end point
    OS will be evaluated when 508 events (deaths) of randomized patients are reported.
    E.5.2Secondary end point(s)
    - Progression-freee Survival (PFS) Time.
    - Best Overall Respose Rate according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
    - Disease control Rate according to Response Evaluation Criteria in solid Tumors (RECIST) version 1.1.
    - Quality of Life (QOL) EuroQuol-5D (EG-5D) Health Outcome questionnaire.
    - Pain intensitiy using a visual analogue scale (VAS).
    - Serum CA 19-9 response rate.
    - Number of participants with treatment-emergent adverse events (TEAE) graded according to National Cancer Institute Common Terminology Criteria for Adverse Eents (NCI CTCAE v.4.03).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Secondary endpoints will be evaluated at the same timepoint as OS data is mature.
    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 No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 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) Yes
    E.8.2.2Placebo Yes
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Gemcitabine
    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 EEA125
    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
    Bulgaria
    Canada
    France
    Ireland
    Italy
    Austria
    Netherlands
    New Zealand
    Romania
    Slovakia
    European Union
    Czech Republic
    Finland
    Germany
    Hungary
    Spain
    Israel
    Poland
    Russian Federation
    South Africa
    Ukraine
    United Kingdom
    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
    Once the event-driven unblinding and final analysis is complete (unblinding and final analysis occurs after 508 events [deaths]), the Sponsor will initiate activities towards execution of an extension protocol, if appropriate, based on study outcomes, so that this Phase III study can be closed.
    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 months4
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months4
    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: 260
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 400
    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 state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 400
    F.4.2.2In the whole clinical trial 660
    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 a subject has completed the trial or has withdrawn early, usual treatment will be administered, if required, in accordance with the trial site’s standard of care and generally accepted medical practice and depending on the subject’s individual medical needs.
    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 Decision2013-07-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-02-27
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-05-04
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