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    EudraCT Number:2017-003424-76
    Sponsor's Protocol Code Number:CTX-SPL9111-001
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:GB - no longer in EU/EEA
    Date on which this record was first entered in the EudraCT database:2017-10-25
    Trial results
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    A. Protocol Information
    A.1Member State ConcernedUK - MHRA
    A.2EudraCT number2017-003424-76
    A.3Full title of the trial
    A phase 1/2 dose-escalation study to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of CTX-SPL9111 (a cabazitaxel (CTX)-dendrimer conjugate) in patients with advanced solid tumours
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A phase 1/2 study in which, CTX-SPL9111, the trial medication will be administered to evaluate the safety, tolerability, pharmacokinetics (distribution of CTX-SPL9111 in the body) and efficacy in patients with advanced solid tumours
    A.4.1Sponsor's protocol code numberCTX-SPL9111-001
    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 SponsorStarpharma Pty Ltd
    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 supportStarpharma Pty Ltd
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationTheradex Oncology
    B.5.2Functional name of contact pointTheradex Regulatory
    B.5.3 Address:
    B.5.3.1Street Address2nd Floor, The Pinnacle, Station Way
    B.5.3.2Town/ cityCrawley, West Sussex
    B.5.3.3Post codeRH10 1JH
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number00441293510319
    B.5.5Fax number00441293510322
    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 nameCTX-SPL9111
    D.3.2Product code CTX-SPL9111
    D.3.4Pharmaceutical form Powder for 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 INNCTX-SPL9111
    D.3.9.1CAS number 183133-96-2
    D.3.9.2Current sponsor codeCTX-SPL9111
    D.3.9.3Other descriptive nameCABAZITAXEL
    D.3.9.4EV Substance CodeSUB31282
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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
    Patients with advanced solid tumours
    E.1.1.1Medical condition in easily understood language
    Patients with advanced solid tumours
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10007050
    E.1.2Term 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
    To establish the maximum tolerated dose (MTD) and dose-limiting toxicities (DLT) of CTX-SPL9111 given intravenously (IV).
    E.2.2Secondary objectives of the trial
    - To characterise the safety and tolerability profile of CTX-SPL9111 in patients
    with advanced cancer
    - To characterise the pharmacokinetics (PK) of CTX-SPL9111
    - To define a recommended dose for phase 2 studies of CTX-SPL9111 dosed
    - To explore preliminary anti-tumour efficacy
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Signed informed consent form.
    2. At least 18 years old.
    3. Patients with histologically or cytologically confirmed advanced or
    metastatic cancer for which no curative therapy exists and who, in the
    opinion of the investigator, could potentially benefit from treatment with
    4. Measurable or evaluable disease per RECIST version 1.1., Prostate Cancer
    Working Group 3 (PCWG3) consensus guidelines (i.e. prostate cancer
    patients with bone-only lesions) or Response Assessment in Neuro-
    Oncology working group consensus guidelines (RANO; patients with
    primary central nervous system malignancy).
    5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
    6. Life expectancy of greater than 12 weeks.
    7. Reproductive inclusion criteria:
    a. If of childbearing potential, willing to use an effective form of
    contraception (see below) during chemotherapy treatment and for at
    least six months thereafter.
    Such methods include (if using hormonal contraception this method
    must be supplemented with a barrier method, preferably male condom):
     combined (estrogen and progestogen containing) hormonal
    contraception associated with inhibition of ovulation:
    - oral
    - intravaginal
    - transdermal
     progestogen-only hormonal contraception associated with inhibition
    of ovulation:
    - oral
    - implantable
     intrauterine device (IUD)
     intrauterine hormone-releasing system (IUS)
     bilateral tubal occlusion
     vasectomised partner
     true sexual abstinence when this is in line with the preferred and
    usual lifestyle of the subject. Periodic abstinence (e.g., calendar,
    ovulation, symptothermal, post-ovulation methods), declaration of
    abstinence for the duration of a trial, and withdrawal are not
    acceptable methods of contraception.
    b. Women must have a negative pregnancy test at study entry.
    c. Men who are truly sexually abstinent when this is in line with the
    preferred and usual lifestyle of the subject or vasectomized or willing to
    ensure that their female sexual partners use a highly-effective means of
    contraception (i.e. as outlined in Inclusion criterion 7.a.) for the duration
    of study therapy and 6 months afterwards. In addition, men must be
    willing to use a condom during sexual intercourse from the first dose of
    CTX-SPL9111 until 6 months after their final dose, so as to protect their
    partner from exposure to study drug.
    E.4Principal exclusion criteria
    1. Uncontrolled brain metastases or spinal cord compression. Patients who
    were treated with surgical resection or radiation therapy completing at least
    4 weeks earlier are eligible if they are neurologically stable and have a follow-up MRI scan performed within the previous 4 weeks showing no
    tumour progression.
    2. Inadequate bone marrow reserve as demonstrated by an absolute neutrophil
    count (ANC) < 1.5 × 109/L or platelet count < 100 × 109/L (cannot be post-
    transfusion) or haemoglobin < 10 g/dL (can be post-transfusion).
    3. Serum bilirubin > upper limit of normal (ULN).
    4. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST)
    level > 1.5 × ULN.
    5. Serum creatinine > 1.5 × ULN; however, an exception can be made if the
    calculated (by the Cockcroft-Gault formula) or measured creatinine
    clearance is > 50 mL/min.
    6. History of a bleeding diathesis.
    7. Allergy to cabazitaxel, other components of study therapy or compounds of
    similar chemical composition.
    8. Congenital long-QT syndrome.
    9. Myocardial infarction within 6 months of enrolment, congestive heart failure
    of New York Heart Association class > II, unstable angina or unstable
    cardiac arrhythmias.
    10. Other uncontrolled intercurrent illness, including active infection.
    11. A history of infection with HIV or hepatitis B or C viruses.
    12. Participation in a study of an investigational agent within 30 days prior to
    first study therapy.
    13. Anti-tumour therapy (including chemotherapy, radiation therapy, targeted
    therapeutics or hormonal therapy) within the 30 days prior to first study
    therapy. Permitted exceptions are concurrent use of GnRH
    agonists/antagonists for prostate cancer and radiation to bone metastases
    completed > 14 days prior to first study therapy.
    14. Cumulative dose of corticosteroid ≥ 150 mg prednisone (or equivalent doses
    of corticosteroids) within two weeks before the first IMP administration.
    15. Unresolved toxicity from prior anti-tumour therapy, defined as toxicities
    (excluding alopecia) that have not resolved to < grade 2 as scored using the
    Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
    Exceptions may be allowed for stable toxicities after discussion with the
    investigator and sponsor.
    16. Symptomatic grade 1 peripheral neuropathy.
    17. Peripheral neuropathy of grade 2 or higher due to any cause.
    18. Patients with diabetes with signs or symptoms of peripheral neuropathy or
    other end organ damage or those at a higher risk of peripheral neuropathy
    (eg: history of poor diabetes control or non-compliance with anti-diabetic medication).
    19. Major surgery within 30 days of commencing first study therapy.
    20. Pregnant or breast-feeding females.
    21. Concurrent or planned treatment with strong inhibitors (e.g. ketoconazole,
    itraconazole, clarithromycin, indinavir, nefazodone, nelfinavir, ritonavir,
    saquinavir, telithromycin, voriconazole) or inducers (e.g., phenytoin,
    carbamazepine, rifampin, rifabutin, rifapentin, phenobarbital) of cytochrome
    P450 3A4/5. Concurrent or planned treatment with St John’s Wort.
    Concurrent or planned treatment with Organic Anion-Transporting-
    Polypeptide OATP1B1 substrates (e.g, statins, valsartan, repaglinide) should
    be avoided during CTX-SPL9111 treatment where possible. A 1-week
    washout period is necessary for patients already on these treatments.
    22. Any concurrent condition which, in the Investigator's opinion, makes it
    undesirable for the subject to participate in this study or which would
    jeopardize compliance with the protocol.
    E.5 End points
    E.5.1Primary end point(s)
    14.3 Endpoints
    14.3.1 Safety endpoints
    Toxicity will be graded using the NCI CTCAE v4.03. Safety assessments will include medical
    review of AEs and the results of vital sign measurements, physical examinations, ECGs and
    clinical laboratory tests.
    14.3.2 Pharmacokinetic Endpoints
    Plasma concentrations of free and total cabazitaxel versus time will be analysed using non-
    compartmental methods and a validated PK analysis program to generate the following PK
    parameters for each patient:
    Cmax: Maximum observed plasma concentration.
    Tmax: Time to maximum observed plasma concentration.
    AUC: Area under the concentration-time curve.
    t1/2: Apparent terminal half-life.
    14.3.3 Efficacy Endpoints
    RECIST 1.1 criteria, PCWG3 criteria and RANO criteria will be used to classify tumour responses to CTX-SPL9111 into the following categories: (1) complete response; (2) partial
    response; (3) stable disease; or (4) progressive disease. The following efficacy variables will be
     Objective Response Rate (ORR) based on RECIST 1.1
     Progression Free Survival (PFS) which equals time from enrolment to
    progression or death whichever comes first
     Overall Survival (OS) which equals time from enrolment to death
     Duration of best overall response
     Duration of stable disease
    If progression or death are not observed then the time will be censored at the last tumour
    assessment for PFS, and the last observation for survival.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Please refer to the study protocol.
    E.5.2Secondary end point(s)
    There are no secondary endpoints.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Not applicable
    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. 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 Yes
    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.8.2.4Number of treatment arms in the trial1
    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
    Last patient, last visit in the study.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months3
    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: 11
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 22
    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 No
    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 state33
    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)
    The expected normal treatment for the condition will be provided to the patient under the supervision of their oncologist.
    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 Decision2017-12-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-01-30
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
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