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    Summary
    EudraCT Number:2013-003865-32
    Sponsor's Protocol Code Number:TOK-200-11
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2013-10-15
    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 ConcernedUK - MHRA
    A.2EudraCT number2013-003865-32
    A.3Full title of the trial
    A Pharmacokinetic and Pharmacodynamic Translational Investigation of Galeterone in Patients with Metastatic Castration Resistant Prostate Cancer
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical trial of galeterone for the treatment of castrate resistant prostate cancer
    A.3.2Name or abbreviated title of the trial where available
    A Phase 2 Study of the Pharmacokinetics and Pharmacodynamics of galeterone for treatment of CRPC
    A.4.1Sponsor's protocol code numberTOK-200-11
    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 SponsorTokai Pharmaceuticals, Inc.
    B.1.3.4CountryUnited States
    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 supportTokai Pharmaceuticals, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationTokai Pharmaceuticals, Inc.
    B.5.2Functional name of contact pointClinical Trial Enquiries
    B.5.3 Address:
    B.5.3.1Street AddressOne Broadway, 14th floor
    B.5.3.2Town/ cityCambridge
    B.5.3.3Post codeMA 02142
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1617225 4305
    B.5.5Fax number+1617812 2650
    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 nameGaleterone
    D.3.2Product code TOK-001
    D.3.4Pharmaceutical form 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 INNGALETERONE
    D.3.9.1CAS number 851983-85-2
    D.3.9.3Other descriptive nameGALETERONE
    D.3.9.4EV Substance CodeSUB124320
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number425
    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
    E.1.1.1Medical condition in easily understood language
    Prostate cancer which is spreading
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10066489
    E.1.2Term Progression of prostate cancer
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    a. To evaluate efficacy of galeterone in terms of changes from baseline in PSA concentration
    b. To fully evaluate the pharmacokinetic profile of galeterone at steady state
    E.2.2Secondary objectives of the trial
    a. To further evaluate the safety profile of galeterone
    b. To determine efficacy of galeterone in terms of radiographic findings (DW-MRI)
    c. To assess changes in specific bone markers from baseline
    d. To correlate changes in circulating tumor cell (CTC) counts to outcome, and expression of (androgen receptor) AR in tumor biopsies and CTCs.
    e. To assess the changes in specific markers in steroidogenic pathways
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Signed informed consent form (ICF) providing agreement to adhere to the dosing schedule, report for all trial visits and authorization, use and release of health and research trial information
    2. Male age ≥ 18 years
    3. Histologically or cytologically confirmed adenocarcinoma of the prostate (excluding neuroendocrine differentiation or small cell histology)
    4. Ongoing androgen blockade (therapy with gonadotropin-releasing hormone (GnRH) analogues, or orchiectomy) demonstrated by serum testosterone concentration of less than 50 ng/dL
    5. Demonstration of progression while on androgen blockade (based upon PCWG2 guidelines).
    • Patients must have PSA levels that have risen on at least two successive occasions, at least 1 week apart, with the most recent PSA level ≥2 ng/mL with or without the following:
    a. Nodal spread with no evidence of bone or visceral disease
    b. Bone disease with or without nodal disease and no evidence of visceral spread
    c. Visceral metastases with or without nodal or bone disease
    6. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤2
    7. Life expectancy of > 12 weeks
    8. Able to swallow multiple tablets whole without crunching or breaking
    9. Must have tumor deposits accessible for biopsy
    E.4Principal exclusion criteria
    1. Participation in another clinical trial involving experimental therapy < 4 weeks prior to enrollment.

    2. The following medications :
    a. Prior treatment with CYP17 inhibitors or AR antagonists (e.g. abiraterone, TAK-700, ARN-509, ketoconazole*, enzalutamide, or galeterone)
    * In some cases of prior ketoconazole treatment, patients may be allowed to participate based upon discussion of the individual details between the PI and the Tokai Medical Representative.
    b. Prior treatment of CRPC with chemotherapy agents (including but not limited to taxanes, anthracyclines, mitoxantrone, platinators, etc.)
    c. Treatment with non-steroidal oral antiandrogens (e.g. flutamide, bicalutamide or nilutamide), 5-alpha reductase inhibitors, (e.g. dutasteride, finasteride) within 4 weeks of enrollment
    Note: Patients must show a continued rise in PSA (two consecutive measures at least 2 weeks apart) after the cessation of these therapies
    d. Use of herbal products that may decrease PSA levels (e.g., saw palmetto) within 4 weeks of enrollment or plans to initiate treatment with any of these herbal products during the trial
    e. Prior use of any chronic systemic glucocorticoids within the last 6 months (short course use at Tokai Medical Representative discretion) or plans to initiate treatment with chronic systemic glucocorticoids during the trial
    f. Prior external beam radiation therapy within 3 weeks (if single fraction of radiotherapy within 2 weeks)
    g. Prior treatment with radium 223-dichloride (Xofigo®) or any other therapeutic radionuclide
    h. Treatment with anti arrhythmia therapy for ventricular arrhythmia ≤ 4 weeks prior to enrollment
    i. Treatment with Coumadin® (warfarin sodium) or other anti-coagulant therapy (except aspirin) ≤ 4 weeks prior to enrollment
    j. Ongoing treatment or plans to initiate treatment with spironolactone

    3. The following laboratory findings:
    a. Testosterone >50 ng/dL
    b. Measured or calculated creatinine clearance ≤50 ml/min (CKD-EPI calculation method)
    c. Bilirubin > 2.5x the ULN
    d. Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) > 5x the ULN
    e. Hemoglobin ≤ 9.0 g/dL
    f. Absolute neutrophil count (ANC) ≤ 1.5 x 109/L
    g. Platelets ≤ 100 x 109/L
    h. Serum potassium (K+) < 3.5 mmol/L

    4. The following medical conditions:
    a. New York Heart Association Class III or IV Congestive Heart Failure
    b. Myocardial infarction/unstable angina (within the 6 months prior to enrollment)
    c. Atrial fibrillation
    d. History of chronic or active Hepatitis B or Hepatitis C or other known chronic liver disease (Note: Positive findings on the hepatitis panel will be reviewed by the Tokai Medical Representative to determine eligibility)
    e. Known human immunodeficiency virus (HIV) infection
    f. Uncontrolled hypertension (defined as systolic blood pressure > 160 mmHg or diastolic blood pressure of > 100 mmHg measured on at least two occasions, two weeks apart) despite acceptable anti-hypertension therapy
    g. History of adrenal insufficiency or hyperaldosteronism
    h. Gastrointestinal disorders or gastric bypass surgery including lap bands that could interfere with the absorption of galeterone
    i. Serious active infections requiring systemic treatment or nonmalignant medical illnesses that are uncontrolled
    j. Any history of (in the past 5 years) second malignancy, other than treated non melanoma skin cancer and superficial transitional cell carcinoma of the bladder
    k. Active or uncontrolled autoimmune disease
    l. Active biliary disorders
    m. History of Gilbert’s syndrome
    n. Brain metastases (unless stable disease >3 mos. by scan without additional CNS-directed therapy)
    o. The patient has known allergy to any of the treatment components
    p. Use of any substance known to cause AME

    5. Any physical or mental condition or social situation that in the opinion of the Investigator may interfere with the patient’s ability to comply with the trial procedures

    6. For men who are unwilling to use an adequate method of birth control if engaging in sexual contact with women of child bearing potential, two forms of effective contraception is required (if double barrier method is used (e.g. condom and occlusion cap, it must be used with a spermicide)

    7. History of alcohol consumption greater than 4 drinks/day (defined as a small beer, small glass of wine, single cocktail or shot) for more than 5 days in any week

    8. History of Kava consumption within 4 weeks of study entry and during the study
    E.5 End points
    E.5.1Primary end point(s)
    Safety
    • Incidence and severity of AEs
    • Change from baseline in the following additional safety parameters: clinical laboratory assessments, physical examination, and vital signs
    • Time matched triplicate ECGs
    • Treatment Compliance

    Efficacy
    Antitumor activity
    • Changes in histology on tumor biopsy samples
    • Changes in number of CTCs, AR status and any variants.
    Changes of CTC enumeration from baseline to Day 14 and end of study (Day 84, Trial Conclusion Visit). AR expression will be semi quantified at each of these time points

    PSA changes
    • Percentage of patients with 90%, 50% and 30% or greater decrease in PSA from baseline at end of treatment or PSA nadir (whichever comes first)
    • Maximal change in PSA response from baseline

    Imaging
    • Changes in magnetic resonance imaging (DW-MRI)
    • Changes in NaF PET uptake or standard PET (optional).

    Pharmacokinetics and Pharmacodynamics Translational Assessments
    • Changes from baseline of specific markers in steroidogenic pathway
    • Assessment of pharmacokinetics (PK)
    • Changes in bone makers (bone alkaline phosphatase, acid phosphatase, sCTX, uNTX, P1NP and TRAP-5b)
    • Changes in AR levels and histology in tumor biopsies from baseline to Day 28 and end of study (Day 84, Trial Conclusion Visit)
    • Assessment of galeterone concentration in serum.
    E.5.1.1Timepoint(s) of evaluation of this end point
    At end of study unless otherwise stated above.
    E.5.2Secondary end point(s)
    None
    E.5.2.1Timepoint(s) of evaluation of this end point
    None
    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 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 No
    E.8.1.1Randomised No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA2
    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 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: 10
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 14
    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 state12
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 24
    F.4.2.2In the whole clinical trial 24
    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 Decision2013-11-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-02-12
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2014-07-01
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