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    Summary
    EudraCT Number:2019-002393-31
    Sponsor's Protocol Code Number:OTL-2019-OTL78-001
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2019-06-25
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2019-002393-31
    A.3Full title of the trial
    A phase 1a/1b/2a study to assess the safety, tolerability and pharmacokinetics of OTL78, a PSMA-targeted fluorescent agent, for the intraoperative imaging of prostate cancer
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study for intra-operative imaging of prostate cancer using OTL78
    A.4.1Sponsor's protocol code numberOTL-2019-OTL78-001
    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 SponsorOnTarget Laboratories
    B.1.3.4CountryUnited States
    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 supportOnTarget Laboratories
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCentre for Human Drug Research
    B.5.2Functional name of contact pointJ. Burggraaf
    B.5.3 Address:
    B.5.3.1Street AddressZernikedreef 8
    B.5.3.2Town/ cityLeiden
    B.5.3.3Post code2333 CL
    B.5.3.4CountryNetherlands
    B.5.6E-mailclintrials@chdr.nl
    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 nameOTL78
    D.3.2Product code OTL78
    D.3.4Pharmaceutical form 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 INNOTL0078
    D.3.9.2Current sponsor codeOTL0078
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1.6
    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 Yes
    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 placeboInfusion
    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
    Prostate cancer
    E.1.1.1Medical condition in easily understood language
    Prostate cancer
    E.1.1.2Therapeutic area Diseases [C] - Male diseases of the urinary and reproductive systems [C12]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    - To assess the safety and tolerability of a single IV dosage of OTL78
    E.2.2Secondary objectives of the trial
    Concordance between fluorescent signal and tumor status of resected tissue (PSA and PSAP and AMACR staining on tissue sections according to standard pathology protocol and assessment).
    • To assess the pharmacokinetics of a single IV dose of OTL78
    • To estimate the Sensitivity (or True Positive rate, TP/TP+FN) of OTL78 for
    detection of tissues expressing PSMA during near infrared imaging (NIR)
    • To estimate the Sensitivity (or True Positive rate, TP/TP+FN) of OTL78 for
    detection of prostate cancer cells during near infrared imaging (NIR)
    • To estimate the False Positive rate (FP/FP+TP) of OTL78 for detection of
    tissues expressing PSMA during near infrared imaging (NIR)
    • To estimate the False Positive rate (FP/FP+TP) of OTL78 for detection of
    prostate cancer cells during near infrared imaging (NIR)
    • To evaluate the tumor to background ratio (TBR)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Healthy volunteers
    1) Male and 18-65 years old at screening.
    2) Able and willing to comply with study procedures, with signed and dated informed consent obtained before any study-related procedure is performed.
    3) Agree to use an effective method of contraception for 90 days after administration.
    4) A body mass index is ≤30 kg/m2.
    5) The subject is healthy with no acute or chronic medical illnesses, has a normal physical examination, and normal vital signs findings at screening.
    6) The subject’s screening 12-lead ECG and clinical laboratory test results are within normal limits, or if any are outside of normal limits they are considered clinically insignificant at the discretion of the Investigator
    7) Negative screening test results for hepatitis B, hepatitis C, and human immunodeficiency virus.
    8) Negative test results for drug and alcohol screening.
    9) Absence of any psychological, familial, sociological or geographical condition that at the
    discretion of the investigator could potentially hamper compliance with the study protocol and follow-up schedule; such conditions should be discussed with the patient during the
    prescreening period.

    Patients
    1) Male patients > 18 years of age and older at screening
    2) Able and willing to comply with study procedures, and signed and dated informed consent is
    obtained before any study-related procedures are performed.
    3) Known or high clinical suspicion of primary prostate cancer (Gleason score 7+)
    planned for a prostatectomy
    4) Known or high clinical suspicion of prostate cancer scheduled to undergo a pelvic lymph node dissection
    5) The 12-lead ECG and clinical laboratory test results are within normal limits, or if any are outside of normal limits they are considered clinically insignificant at the discretion of the investigator
    6) Absence of any psychological, familial, sociological or geographical condition that at the
    discretion of the investigator could potentially hamper compliance with the study
    protocol and follow-up schedule; such conditions should be discussed with the patient during the prescreening period.
    7) Chronic or acute medical illness that in the discretion of the investigator may confound or complicate the findings in this study
    8) Patients are clinically fit for surgery
    9) Agree to use an effective method of contraception for 90 days after administration
    10) Absence of any psychological, familial, sociological or geographical condition that at the
    discretion of the investigator could potentially hamper compliance with the study protocol and follow-up schedule; such conditions should be discussed with the patient during the
    prescreening period.
    E.4Principal exclusion criteria
    Healthy volunteers
    1) Female subjects
    2) Known acute or chronic disease, abnormal physical examination or blood tests
    3) The subject has previously been included in an OTL study.
    4) Use of prescription drugs within 30 days of screening and during study participation
    5) Participation in a clinical trial within 90 days of screening or more than 4 times in the previous year.
    6) History of clinically significant allergies or anaphylactic reactions.
    7) History of allergy to any of the components of OTL78 or excipients (see Section 3.2 IB).

    Patients
    1) Any condition that in the opinion of the investigators could potentially jeopardize the health status of the patient
    2) History of clinically significant allergies or anaphylactic reactions.
    3) History of allergy to any of the components of OTL78 or excipients (see Section 3.2 IB)
    4) Impaired renal function defined as eGFR<50 ml/min/1.73m2
    5) Impaired liver function defined as values greater than 3x the upper limit of normal (ULN) for ALT, AST, or 2x the upper limit of normal for total bilirubin (unless due to Gilbert Syndrome)
    6) Previous participation in an OTL study
    E.5 End points
    E.5.1Primary end point(s)
    - To assess the safety and tolerability of a single IV dosage of OTL78
    - To assess the pharmacokinetics of a single IV dosage of OTL78
    E.5.1.1Timepoint(s) of evaluation of this end point
    Safety = at the end of each cohort
    Pharmacokinetics = at the end of each cohort
    E.5.2Secondary end point(s)
    Concordance between fluorescent signal and tumor status of resected tissue (PSA and PSAP and AMACR staining on tissue sections according to standard pathology protocol and assessment).
    • To assess the pharmacokinetics of a single IV dose of OTL78
    • To estimate the Sensitivity (or True Positive rate, TP/TP+FN) of OTL78 for
    detection of tissues expressing PSMA during near infrared imaging (NIR)
    • To estimate the Sensitivity (or True Positive rate, TP/TP+FN) of OTL78 for
    detection of prostate cancer cells during near infrared imaging (NIR)
    • To estimate the False Positive rate (FP/FP+TP) of OTL78 for detection of
    tissues expressing PSMA during near infrared imaging (NIR)
    • To estimate the False Positive rate (FP/FP+TP) of OTL78 for detection of
    prostate cancer cells during near infrared imaging (NIR)
    • To evaluate the tumor to background ratio (TBR)
    E.5.2.1Timepoint(s) of evaluation of this end point
    At the end 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 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) Yes
    E.7.1.1First administration to humans Yes
    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 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 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 years1
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    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: 24
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 24
    F.2 Gender
    F.2.1Female No
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    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 state24
    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 Decision2019-06-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-07-19
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-05-18
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