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    The EU Clinical Trials Register currently displays   43874   clinical trials with a EudraCT protocol, of which   7293   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).

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    Summary
    EudraCT Number:2014-001074-34
    Sponsor's Protocol Code Number:HS-12-460
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-06-02
    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 ConcernedHungary - National Institute of Pharmacy
    A.2EudraCT number2014-001074-34
    A.3Full title of the trial
    A Phase II, Open Label, Active Control, Multi-National, Multi-Centre, Randomized, Parallel Group Study Assessing Pharmacokinetics, Pharmacodynamics, Efficacy and Safety of CAM2032 q1m (Leuprolide Acetate FluidCrystal® Injection Depot once monthly) after Repeat Doses of 3.75 mg and 7.5 mg of Leuprolide Acetate vs. Eligard® 7.5 mg in Patients with Prostate Cancer
    II-es fázisú, nyílt, aktív kontrollú, multinacionális, multicentrikus, randomizált, párhuzamos csoportú klinikai vizsgálat a CAM2032 q1m (leuprolid acetát FluidCrystal® Depot Injekció havonkénti egyszeri adagolásban) készítmény farmakokinetikai, farmakodinamikai, hatékonysági és biztonságossági vizsgálatára, megismételt adagolás során 3,75 mg vagy 7,5 mg leuprolid acetát, illetve 7,5 mg-os Eligard® kontroll készítmény adásakor, prosztata karcinómában szenvedő betegek esetében
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study of efficacy and safety of CAM2032 q1m compared to Eligard® in patients with prostate cancer
    A.3.2Name or abbreviated title of the trial where available
    N/A
    A.4.1Sponsor's protocol code numberHS-12-460
    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 SponsorCamurus 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 supportCamurus AB
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationTFS Trial Form Support Kft
    B.5.2Functional name of contact pointCRA
    B.5.3 Address:
    B.5.3.1Street AddressÁrpád Fejedelem útja 26-28.
    B.5.3.2Town/ cityBudapest
    B.5.3.3Post codeH-1023
    B.5.3.4CountryHungary
    B.5.4Telephone number+36307902818
    B.5.5Fax number+3617826830
    B.5.6E-maileszter.forizs@tfscro.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 nameCAM2032 q1m
    D.3.4Pharmaceutical form Injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLEUPRORELIN ACETATE
    D.3.9.1CAS number 74381-53-6
    D.3.9.2Current sponsor codeCAM2032 q1m
    D.3.9.4EV Substance CodeSUB02900MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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 RoleComparator
    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 Eligard
    D.2.1.1.2Name of the Marketing Authorisation holderAstellas Pharma Kft.
    D.2.1.2Country which granted the Marketing AuthorisationHungary
    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.3.4Pharmaceutical form Powder and solvent for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLEUPRORELIN ACETATE
    D.3.9.1CAS number 74381-53-6
    D.3.9.4EV Substance CodeSUB02900MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number7.5
    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
    Prostate cancer
    E.1.1.1Medical condition in easily understood language
    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 17.0
    E.1.2Level PT
    E.1.2Classification code 10060862
    E.1.2Term Prostate cancer
    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
    To characterize the PK profiles after repeated administration of CAM2032 q1m, at doses of 3.75 mg and 7.5 mg leuprolide acetate, in patients with prostate cancer
    E.2.2Secondary objectives of the trial
    - To assess and compare the PK profiles after repeat subcutaneous injections of CAM2032 q1m 3.75 mg and 7.5 mg vs. Eligard 7.5 mg
    - To assess the relative bioavailability of leuprolide when administered as repeat doses of CAM2032 q1m 3.75 mg and 7.5 mg vs. when administered as the active comparator Eligard® 7.5 mg
    - To assess and compare the PD profiles of s-T levels after repeat doses of CAM2032 q1m 3.75 mg and 7.5 mg vs. Eligard 7.5 mg
    - To assess time to T recovery after the last dose of CAM2032 q1m 3.75 mg and 7.5 mg vs. Eligard 7.5 mg
    - To assess the effect of repeat doses of CAM2032 q1m 3.75 mg and 7.5 mg vs. Eligard 7.5 mg, on serum prostate specific antigen (s-PSA) levels
    - To assess and compare safety of repeat doses of CAM2032 q1m, 3.75 mg and 7.5 mg vs. Eligard 7.5 mg
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Men ≥40 and ≤85 years of age
    2. Histological or cytological proven adenocarcinoma of the prostate requiring hormone therapy (Classification of Malignant Tumours [TNM] stages: T3-4 NX M0, T1-4N1-3 M0 and T1-4 NX-3 M1 equivalent to the American Urology Association stages : C1/C2 and D1/D2)
    3. Life expectancy over 12 months
    4. World Health Organisation/ The Eastern Cooperative Oncology Group (WHO/ECOG) performance status of 0, 1 or 2
    5. Adequate and stable renal function i.e. serum creatinine ≤1.6 times the upper limit of normal (ULN) at Screening visit
    6. Adequate and stable hepatic function i.e. serum bilirubin ≤1.5 times the ULN, and aspartate aminotransferase/serum glutamate oxaloacetate transaminase (ASAT/SGOT) and alanine aminotransferase/serum glutamate pyruvate transaminase (ALAT/SGPT) ≤2.5 times the ULN at Screening visit
    7. Able to provide written informed consent to participate in the study and able to understand the procedures and study requirements
    8. Willing and able to comply with the study requirements and complete the study assessments
    E.4Principal exclusion criteria
    1. Evidence of brain metastasis, spinal cord compression, or urinary tract obstruction
    2. S-T levels below 150 ng/dL at Screening visit
    3. Medical or radiological prostate cancer treatments within 2 months prior to the Screening visit
    4. Surgical treatment of prostate cancer within 2 weeks prior to the Screening visit
    5. Known hypersensitivity to luteinizing hormone releasing hormone (LHRH) agonists or other components of CAM2032 q1m or Eligard 7.5 mg
    6. Prior orchiectomy, hypophysectomy, or adrenalectomy
    7. Prior use of LHRH agonists within 12 months prior to the Screening visit and during the study
    8. Proven lack of efficacy when treated with LHRH agonists
    9. Use of finasteride within 3 months prior to the Screening visit
    10. Anticipated need of any other concomitant therapy for prostate cancer for the duration of the study
    11. Use of alternative medicinal therapies with estrogenic, androgenic or anti-androgenic effects within 3 months prior to the Screening visit
    12. Ketoconazole or corticoids, oral/parenteral formulations within 2 months prior to the Screening visit
    13. Diagnosis of any other cancer without a history of stability/remission within 5 years prior to the Screening visit, with the exception of non-metastatic basal and/or squamous cell carcinoma of the skin
    14. Clinically significant laboratory test result that, in the opinion of the investigator, could compromise the patient’s welfare, or otherwise contraindicate study participation
    15. Clinically significant unstable cardiac, respiratory, neurological, immunological, endocrinological, haematological, hepatic, bile duct, urological, or renal disease or any other condition that, in the opinion of the investigator, could compromise the patient’s welfare, or otherwise contraindicate study participation
    16. Tested positive for human immunodeficiency virus (HIV), Hepatitis B or C
    17. History of drug and/or alcohol abuse within 1 year prior to the Screening visit and/or positive urine drug test at Screening visit
    18. Considered by the investigator, for any reason (including, but not limited to, the risks described as precautions, warnings, and contraindications in the current version of the Investigator’s Brochure (IB) for CAM2032 q1m) to be an unsuitable candidate to receive the study medication
    19. Likely to be of poor protocol compliance, as judged by the investigator
    20. Any other condition or deviation that, in the investigator’s opinion, makes the patient unsuitable for participation in the study
    21. Participation in another study of investigational drugs or devices parallel to, or less than 30 Days before the Screening visit, or previous enrolment in this study
    22. Employee of the investigator or the study site, with direct involvement in the proposed study or other studies under the direction of the investigator or study site, or is a family member of an employee or of the investigator
    E.5 End points
    E.5.1Primary end point(s)
    PK parameter estimates for characterizing the PK-profiles after first injection of study medication are: Cmax, Ctrough, Cmin, tmax, λz, t½, AUClast, AUCtau, AUCinf, AUC24h, AUC7d, Cavg and %Fluctuation, and after the third injection of study medication: Cmax, Ctrough, Cmin, tmax, λz, t½, AUClast, AUCtau, Cavg and %Fluctuation
    E.5.1.1Timepoint(s) of evaluation of this end point
    After first injection of study medication and after the third injection of study medication (see E.5.1).
    E.5.2Secondary end point(s)
    - The profiles of s-T concentration (ng/dL), following each injection of the study medication.
    - Proportion of patients with s-T below 50 ng/dL from day 28 to 84, i.e. during the second and third dose periods.
    - Time to s-T recovery: the end of s-T suppression below 50 ng/dL after last injection of the study medication.
    - Time to s-T suppression below 50 ng/dL.
    - Duration of suppression of s-T below 50 ng/dL after injection of the study medication.
    - Days of suppression of s-T below 50 ng/dL after repeated injection of the study medication.
    - Number of occasions when the s-T exceeds 50 ng/mL and percentage of patients with s-T control escapes after injection of study medication.
    - S-PSA (ng/ml) response to study medication.
    E.5.2.1Timepoint(s) of evaluation of this end point
    See E.5.2
    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 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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other No
    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 concerned6
    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 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 years0
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months9
    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: 20
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 35
    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 state27
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 55
    F.4.2.2In the whole clinical trial 55
    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)
    At the discretion of the investigator, standard of care.
    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 Decision2014-07-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-06-30
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-11-10
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