Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43861   clinical trials with a EudraCT protocol, of which   7284   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2015-005666-37
    Sponsor's Protocol Code Number:ODX-003
    National Competent Authority:Estonia - SAM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-06-16
    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 ConcernedEstonia - SAM
    A.2EudraCT number2015-005666-37
    A.3Full title of the trial
    A randomized, double-blind, dose finding, repeat dose Phase II multicentre study of ODX for the treatment of patients with castration resistant prostate cancer (CRPC) and skeletal metastases
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A double-blind, multi-centre phase II dose finding study of ODX (Osteodex) in for patients with castration resistant prostate cancer and skeletal metastates
    A.4.1Sponsor's protocol code numberODX-003
    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 SponsorDexTech Medical AB
    B.1.3.4CountrySweden
    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 supportDexTech Medical AB
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDexTech Medical AB
    B.5.2Functional name of contact pointPublic Relations Director
    B.5.3 Address:
    B.5.3.1Street AddressBox 389
    B.5.3.2Town/ cityUppsala
    B.5.3.3Post code75106
    B.5.3.4CountrySweden
    B.5.4Telephone number+46733242782
    B.5.6E-mailarh@telia.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 nameOsteodex
    D.3.2Product code ODX
    D.3.4Pharmaceutical form Concentrate and solvent for solution for injection/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 INNOsteodex
    D.3.9.2Current sponsor codeODX
    D.3.9.3Other descriptive namedextran-guanidine-bisphosphonate conjugate
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number20 to 30
    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
    Metastatic Castration Resistant Prostate Cancer (CRPC) and skeletal metastases
    E.1.1.1Medical condition in easily understood language
    Metastatic Prostate Cancer
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level PT
    E.1.2Classification code 10036909
    E.1.2Term Prostate cancer metastatic
    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
    The primary objective is to evaluate the relative change from baseline in response markers related to bone metabolism (B-ALP and S P1NP) at 12 weeks of three different doses of ODX (3.0, 6.0 and 9.0 mg/kg ODX).
    E.2.2Secondary objectives of the trial
    The secondary objectives of this study are to compare the effects of three different doses of ODX plus best standard of care on the following:
    • progression free survival
    • overall survival
    • change in response markers related to bone metabolism (B-ALP and S-P1NP) at each timepoint except 12 weeks.
    • change in response markers related to bone metabolism (S-CTX and osteocalcin) at each timepoint sampled.
    • change in PSA
    • time to PSA, ALP and P1NP progression
    • pain (FACT-P and EQ-5D-5L questionnaire)
    • analgesic consumption
    • therapy response based on changes in tumor cell metabolism according to RECIST measured with CT.
    • changes from baseline in bone metastasis by means of bone scan at each time point examined.
    • occurrence of symptomatic skeletal events (SSEs; clinically significant pathological fracture, radiation therapy to bone, surgery to bone, or spinal cord compression)
    • safety, tolerability and quality of life (FACT-P and EQ-5D-5L questionnaire)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Age ≥18 years at the time of signing the informed consent form
    2. Histologically or cytologically confirmed diagnosis of adenocarcinoma of the prostate
    3. Evidence of disease progression based on changes in metastatic bone disease (≥ 2 bone lesions compared to a prior examination) in bone scan and/or other imaging modality
    4. Evidence of PSA progression in three consecutive determinations at minimum 1 week intervals
    5. Castrate level of serum testosterone ≤1.7 nmol/L
    6. Performance status ECOG 0-2
    7. Laboratory requirements:
    Haematology:
    Neutrophils ≥ 1.5 x 109/l
    Haemoglobin ≥ 90 g/l
    Platelets ≥ 100 x 109/l
    Hepatic function:
    Total S-bilirubin ≤ 1.5 times the upper limit of normal (ULN)
    AST (SGOT) / ALT (SGPT) ≤ 2.5 times ULN or ≤ 5 times ULN in patients with known liver metastases
    Renal function:
    S-creatinine (S-Cr)≤ 1.5 times ULN
    8. No evidence (≤ 5 years) of prior malignancies (except successfully treated basal cell or squamous cell carcinoma of the skin)
    9. Able to adhere to the study visit schedule and other protocol requirements
    10. Life expectancy ≥6 months
    E.4Principal exclusion criteria
    1. Concurrent use of other anti-cancer agents or treatments, with the following exception: a stable dose of LHRH agonist/antagonist or polyestradiol phosphate. Washout period: bicalutamide 6 weeks; flutamide 4 weeks; abiraterone / enzalutamide 6 weeks, chemotherapy 4 weeks; Radium-223 4 weeks; Strontium-89 or Samarium-153 6 months.
    2. Any treatment modalities involving palliative radiation therapy or major surgery within 4 weeks prior to treatment in this study
    3. Simultaneous participation in any other study involving investigational drugs or having participated in a study less than 4 weeks prior to start of study treatment
    4. Any condition, including the presence of laboratory abnormalities, which confounds the ability to interpret data from the study or places the patient at unacceptable risk if he participates in the study
    5. Known brain metastases
    6. Dental surgery (dental extraction), periodontal disease, local trauma including poorly fitting dentures within 6 months prior to the first dose of study drug
    7. Treatment with bisphosphonates or denosumab within 4 weeks prior to first dose of study medication
    E.5 End points
    E.5.1Primary end point(s)
    Relative change from baseline in response markers related to bone metabolism (B-ALP and S-P1NP) at 12 weeks of three different doses of ODX (3.0, 6.0, 9.0 mg/kg ODX).
    E.5.1.1Timepoint(s) of evaluation of this end point
    A DMC (Data Monitoring Committee) will be established to review unblinded study information during the conduct of the study. Based on its review the DMC will provide the sponsor with recommendations regarding study modification, continuation or termination.

    E.5.2Secondary end point(s)
    • Progression free survival, defined as time from randomization until disease progression or death from any cause
    • Overall survival, defined as the time from randomization to the date of death from any cause
    • Change from baseline in response markers related to bone metabolism (B-ALP and S-P1NP) at each time point sampled (except 12 weeks)
    • Change from baseline in response markers related to bone metabolism (S-CTX and osteocalcin) at each time point sampled
    • Change from baseline in PSA at each time point sampled
    • Time to PSA progression (defined as ≥25% increase from baseline and an absolute value increase ≥2 ng/mL at ≥12 weeks [in patients with no PSA decline from baseline] or ≥25% increase and an absolute value increase ≥2 ng/mL above nadir which is confirmed by a second value 3 or more weeks later [in patients with an initial PSA decline from baseline])
    • Time to ALP progression (defined as ≥25% increase from baseline at ≥12 weeks from baseline [in patients with no total ALP decline from baseline] or ≥25% increase above the nadir value which is confirmed by a second value 3 or more weeks later [in patients with an initial total ALP decline from baseline])
    • Time to P1NP progression (defined as ≥25% increase from baseline at ≥12 weeks from baseline [in patients with no total P1NP decline from baseline] or ≥25% increase above the nadir value which is confirmed by a second value 3 or more weeks later [in patients with an initial total P1NP decline from baseline])
    • Time to progression in bone
    • Time to progression in soft tissue
    • Pain (FACT-P and EQ-5D-5L questionnaire)
    • Analgesic consumption
    • Therapy response based on changes from baseline according to RECIST criteria based on diagnostic CT in patients with measurable soft tissue metastases
    • Change from baseline in bone metastasis by means of bone scan (progression in bone will be defined as at least two or more new lesions on bone scan compared with prior scan at trial entry with a confirmatory bone scan performed 6 or more weeks later showing ≥ 2 additional new lesions (27); therapy response will be assessed based on the difference in BSI from baseline and a threshold of 0.3 BSI-units (28)).
    • Occurence of symptomatic skeletal events (SSEs; symptomatic pathological fracture, palliative radiation therapy to bone, surgery to bone, or spinal cord compression)
    • Safety, tolerability and quality of life (FACT-P and EQ-5D-5L questionnaire)
    E.5.2.1Timepoint(s) of evaluation of this end point
    The study starts with parallel double-blind randomization of 3 mg/kg and 6 mg/kg. After a minimum number of 12 patients have been randomized to each of the two doses, an unblinded Data Monitoring Committee (DMC) will assess whether or not the study can proceed with enrolment of further patients. The DMC will also assess whether or not the dose level of 9 mg/kg can be included into the randomization. If there should be any concerns, the DMC may recommend a third dose level lower than 9 mg/kg or even lower than 6 mg/kg, i.e., an intermediate dose between 3 and 6 mg/kg.
    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 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) 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 Yes
    E.8.1.7.1Other trial design description
    Study is a dose-finding study divided into three arms with 3, 6 and 9 mg/kg ODX.
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Three different doses of ODX (3, 6 and 9 mg/kg)
    E.8.2.4Number of treatment arms in the trial3
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA10
    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 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 years1
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    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: 60
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 60
    F.2 Gender
    F.2.1Female No
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 60
    F.4.2.2In the whole clinical trial 60
    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 Decision2016-08-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-06-28
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-04-29
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Thu Apr 25 22:18:39 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA