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    Summary
    EudraCT Number:2013-000522-58
    Sponsor's Protocol Code Number:NPM001
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2014-06-18
    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 ConcernedGermany - BfArM
    A.2EudraCT number2013-000522-58
    A.3Full title of the trial
    A randomized, double blind, phase II trial of pazopanib versus placebo as maintenance therapy in patients with retroperitoneal and visceral high-risk soft tissue sarcomas following prior- and/or adjuvant doxorubicin / ifosfamide chemotherapy with regional hyperthermia
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    In the study it will be analyzed if treatment with pazopanib, which is given after primary therapy (e.g. surgery, radiation, chemotherapy and hyperthermia), is able to decrease the risk of recurrence of the tumor in comparison to placebo.
    A.3.2Name or abbreviated title of the trial where available
    NEOPAMAIN
    A.4.1Sponsor's protocol code numberNPM001
    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 SponsorKlinikum der Universität München
    B.1.3.4CountryGermany
    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 supportGlaxoSmithKline GmbH & Co. KG
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationKlinikum derUniversität München
    B.5.2Functional name of contact pointMed. Klinik und Poliklinik III
    B.5.3 Address:
    B.5.3.1Street AddressMarchioninistr. 15
    B.5.3.2Town/ cityMunich
    B.5.3.3Post code81377
    B.5.3.4CountryGermany
    B.5.4Telephone number004989440074768
    B.5.5Fax number004989440074776
    B.5.6E-maillars.lindner@med.uni-muenchen.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 Yes
    D.2.1.1.1Trade name Votrient
    D.2.1.1.2Name of the Marketing Authorisation holderGlaxo Group 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 namePazopanib
    D.3.2Product code GW786034
    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 INNPAZOPANIB HYDROCHLORIDE
    D.3.9.1CAS number 635702-64-6
    D.3.9.4EV Substance CodeSUB31270
    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.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 Votrient
    D.2.1.1.2Name of the Marketing Authorisation holderGlaxo Group 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 namePazopanib
    D.3.2Product code GW786034
    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 INNPAZOPANIB HYDROCHLORIDE
    D.3.9.1CAS number 635702-64-6
    D.3.9.4EV Substance CodeSUB31270
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number400
    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 placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    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
    E.1.1.1Medical condition in easily understood language
    Patient with high risk soft tissue cancer
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 15.1
    E.1.2Level HLGT
    E.1.2Classification code 10041299
    E.1.2Term Soft tissue sarcomas
    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
    Primary objective:
    To compare the effectiveness, as measured by PFS according to RECIST v 1.1, of maintenance pazopanib
    given as a continuous daily dose over maximally 24 months versus placebo maintenance in patients with
    high-risk retroperitoneal or visceral soft tissue sarcomas who show no evidence of disease after multimodal
    treatment including neo- and/or adjuvant doxorubicin / ifosfamide chemotherapy with regional hyperthermia,
    tumor resection and radiotherapy, if indicated.
    E.2.2Secondary objectives of the trial
    Secondary objectives:
    Key secondary objectives:
    · To describe the toxic effects of pazopanib given in a continuous daily schedule
    · To determine LPFS, DPFS and OS of treated patients
    Other secondary objectives are to assess health related quality of life (QOL) as assessed by EORTC QLQC30,
    and to investigate predictive biomarkers.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subjects must provide written informed consent prior to performance of study-specific procedures or
    assessments and must be willing to comply with treatment and follow up.
    Note: Informed consent may be obtained prior to start of the specified screening window.
    Note: Procedures conducted as part of the subject’s routine clinical management (e.g., blood count,
    imaging study such as bone scan) and obtained prior to signing of informed consent may be utilized
    for screening or baseline purposes provided these procedures are conducted as specified in the
    protocol
    2. Age ≥ 18 years
    3. Patients must have histological evidence of high-grade soft tissue sarcoma (grade 2 – 3) according
    to the FNLCC grading system, tumor size ≥ 5 cm and deep localization, excluding the following
    tumor types:
    · Embryonal rhabdomyosarcoma
    · Chondrosarcoma (excluding extraskeletal myxoid chondrosarcoma)
    · Osteosarcoma (excluding extraskeletal osteosarcoma)
    · Ewing tumors / primitive neuroectodermal tumor (PNET)
    · Gastro-intestinal stromal tumors (GIST)
    · Dermatofibrosarcoma protuberans
    4. Patients who had undergone previous surgery with inadequate margins (tumour-free margins ≤1 cm
    or margins contaminated) are eligible if thermochemotherapy has been started within 8 weeks of
    surgery. The decision of a re-resection after 4 cycles of thermochemotherapy will be made by the multidisciplinary tumor board.
    5. Unstained slides and ideally tumour blocks must be available for histological central review
    6. Completed 4 to 8 cycles of thermochemotherapy with doxorubicin and ifosfamide at least 21 days
    but no more than 42 days prior to study entry
    7. No evidence of disease following completion of first-line thermochemotherapy and within ≤ 21 days
    of study entry
    8. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
    9. No other prior chemotherapy except thermochemotherapy with doxorubicin and ifosfamide
    10. Adequate organ system function as defined in Table 2
    11. Women of childbearing potential must have a negative serum pregnancy test within 14 days of first
    dose of study treatment and agree to use effective contraception as defined in section 7.1.11 Inclusion criteria during the study and for 14 days following the last dose of investigational product.
    12. Male patients with female partners of childbearing potential must meet one of the following criteria:
    o At least 6 weeks after surgical sterilization by vasectomy with documentation of azoospermia
    o Correct use of two reliable contraception methods for 14 days before exposure to IMP,
    through the dosing period, and for at least 21 days after the last dose of IMP. This includes
    every combination of a hormonal contraceptive (such as oral, injection, transdermal patch,
    implant, cervical ring) or an IUD/IUS with a barrier method (diaphragm, cervical cap, Lea
    contraceptive, femidom, or condom).
    o Complete sexual abstinence for 14 days before exposure to IMP, through the dosing period,
    and for at least 21 days after the last dose of IMP.
    E.4Principal exclusion criteria
    1. No prior or concurrent second primary malignant tumors (except adequately treated in situ
    carcinoma of cervix, or basal cell carcinoma).
    2. No symptomatic or known Central nervous system (CNS) metastases at baseline.
    3. Clinically significant gastrointestinal abnormalities that may increase the risk for gastrointestinal
    bleeding including, but not limited to:
    · Active peptic ulcer disease
    · Known intraluminal metastatic lesion/s with risk of bleeding
    · Inflammatory bowel disease (e.g. ulcerative colitis, Chrohn’s disease), or other
    gastrointestinal conditions with increased risk of perforation
    · History of abdominal fistula, gastrointestinal perforation, or intra abdominal abscess within
    28 days prior to beginning study treatment.
    4. Clinically significant gastrointestinal abnormalities that may affect absorption of investigational
    product including, but not limited to:
    · Malabsorption syndrome
    · Major resection of the stomach or small bowel.
    5. Corrected QT interval (QTc) > 480 msecs
    Note: Correction method should be reported in CRF
    6. History of any one or more of the following cardiovascular conditions within the past 6 months:
    · Cardiac angioplasty or stenting
    · Myocardial infarction
    · Unstable angina
    · Coronary artery bypass graft surgery
    · Symptomatic peripheral vascular disease
    · Class III or IV congestive heart failure, as defined by the New York Heart Association
    (NYHA) (See Appendix D)
    7. Poorly controlled hypertension (SBP of ≤ 150 mmHg or DBP of ≤95 mmHg is acceptable provided
    that BP will be treated and monitored at least weekly. The goal is to attain controlled hypertension
    within 4 weeks of start of IMP which is defined as grade ≤1 hypertension CTCAE Version 4.0)
    Note: Initiation or adjustment of antihypertensive medication(s) is permitted prior to study entry. BP
    must be re-assessed twice with an interval of at least 1h before start of treatment and should be
    ≤140/90 mmHg for a subject to be eligible for the study. However, BP of ≤150/95 mmHg is
    acceptable provided the above measures are employed.
    8. NYHA II at Screening for Patients > 65 years
    9. History of cerebrovascular accident including transient ischemic attack (TIA), pulmonary embolism or
    untreated deep venous thrombosis (DVT) within the past 6 months.
    Note: Subjects with recent DVT who have been treated with therapeutic anti-coagulating agents for
    at least 6 weeks are eligible
    10. Major surgery or trauma within 28 days prior to first dose of investigational product and/or presence
    of any non-healing wound, fracture, or ulcer (procedures such as catheter placement not considered
    to be major surgery).
    11. Evidence of active bleeding or bleeding diathesis.
    12. Known endobronchial lesions and/or lesions infiltrating major pulmonary vessels that increase the
    risk of pulmonary hemorrhage
    Note: Lesions infiltrating major pulmonary vessels (contiguous tumour and vessels) are excluded;
    however, the presence of a tumor that is touching, but not infiltrating (abutting) the vessels is
    acceptable (CT with contrast is strongly recommended to evaluate such lesions).
    · Large protruding endobronchial lesions in the main or lobar bronchi are excluded; however,
    endobronchial lesions in the segmented bronchi are allowed.
    · Lesions extensively infiltrating the main or lobar bronchi are excluded; however, minor
    infiltrations in the wall of the bronchi are allowed.
    13. Recent hemoptysis (≥½ teaspoon of red blood within 8 weeks before first dose of study drug).
    14. Any serious and/or unstable pre-existing medical, psychiatric, or other condition that could interfere
    with subject’s safety, provision of informed consent, or compliance to study procedures.
    15. Unable or unwilling to discontinue use of prohibited medications listed in section 9.3.3 for at least 14
    days or five half-lives of a drug (whichever is longer) prior to the first dose of study drug and for the
    duration of the study.
    16. Treatment with any of the following anti-cancer therapies:
    · radiation therapy, surgery or tumor embolization within 14 days prior to the first dose of
    pazoapnib OR
    · chemotherapy, immunotherapy, biologic therapy, investigational therapy or hormonal
    therapy within 14 days or five half-lives of a drug (whichever is longer) prior to the first dose
    of pazopanib
    17. Administration of any non-oncologic investigational drug within 30 days or 5 half lives whichever is
    longer prior to receiving the first dose of study treatment
    18. Any ongoing toxicity from prior anti-cancer therapy that is >Grade 1 and/or that is progressing in
    severity, except alopecia.
    E.5 End points
    E.5.1Primary end point(s)
    Primary efficacy endpoint:
    PFS calculated as time from date of randomization until the date of first objective documentation of disease
    progression, treatment failure, or death due to any cause, whichever occurs first.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Date of first objective documentation of disease
    progression, treatment failure, or death due to any cause, whichever occurs first.
    E.5.2Secondary end point(s)
    Secondary endpoints:

    Key secondary endpoints:
    · Rates of grade 3 or 4 toxicities during pazopanib or placebo maintenance
    · Local progression-free survival (LPFS), defined as time from randomization to the date of local tumor
    relapse or death, whichever occurred first and irrespective of any occurrence of distant metastases
    · Distant progression-free survival (DPFS), defined as time from randomization to the date of
    metastasis formation whichever occurred first.
    · Overall survival (OS) will be calculated from date of randomization to date of death (from any cause).
    Patients alive will be censored at time of last follow-up.

    Further secondary endpoints:
    · QoL: Quality of life questionnaire (QLQ-C30; Appendix B) will be collected at baseline (day -21 to 1),
    after 3, 6, 9, 12, 15, 18, 21 and 24 months from date of randomization and 3 months after last dose
    (end of treatment (EOT)).
    · Biomarker assessment to predict PFS at 2 years from date of randomization
    E.5.2.1Timepoint(s) of evaluation of this end point
    Please refer to E.5.2 Secondary Endpoints
    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 No
    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 Yes
    E.6.13.1Other scope of the trial description
    - Biomarker assessment
    - QoL assessment
    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) Yes
    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 concerned4
    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 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 years5
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned 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: 100
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    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 state150
    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 Decision2014-07-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-10-02
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2016-07-29
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
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