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    Summary
    EudraCT Number:2012-003064-47
    Sponsor's Protocol Code Number:CUDC-101-104
    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:2012-07-30
    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 number2012-003064-47
    A.3Full title of the trial
    A Phase 1 open-label study to investigate the pharmacodynamics, metabolomics and pharmacokinetics of CUDC-101 in subjects with HER2 positive invasive breast cancer.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 1 study of the body and tumour effects of CUDC-101 in HER2 positive breast cancer patients
    A.4.1Sponsor's protocol code numberCUDC-101-104
    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 SponsorCuris, 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 supportCuris, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCuris, Inc.
    B.5.2Functional name of contact pointRobert Laliberte
    B.5.3 Address:
    B.5.3.1Street Address4 Maguire Road
    B.5.3.2Town/ cityLexington
    B.5.3.3Post codeMA 02421
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1617503-6538
    B.5.5Fax number+1617503-6501
    B.5.6E-mailrlaliberte@curis.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 nameCUDC-101
    D.3.2Product code CUDC-101
    D.3.4Pharmaceutical form Powder for solution 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 INNCUDC-101
    D.3.9.2Current sponsor codeCUDC-101
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number306
    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
    HER2 positive breast cancer
    E.1.1.1Medical condition in easily understood language
    breast cancer
    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 10065430
    E.1.2Term HER-2 positive breast 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 explore changes in tumour levels of Ki-67 and AcH3 measured by IHC from matched biopsies taken pre- and post- short-term 5-day treatment with CUDC-101 given as a 1 hour I.V. infusion at 275 mg/m2 in subjects with HER2 positive invasive breast cancer.
    E.2.2Secondary objectives of the trial
    1. To assess the pharmacokinetics of CUDC-101.
    2. To assess the safety of short-term treatment with CUDC-101.
    3. To measure clinical response to short-term treatment with CUDC-101.
    4. To assess additional markers of CUDC-101 pharmacodynamic activity in tumour tissue and peripheral blood mononuclear cells (PBMCs).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Female subjects with invasive breast cancer.
    2. Tumour must be confined to either the breast or to the breast and ipsilateral axilla, measuring >15mm.
    3. HER2-positive defined using FISH/CISH and/or DAKO +++ positivity.
    4. Histologically confirmed through either core needle biopsy or an incisional biopsy. Excisional biopsy will not be allowed.
    5. Measurable or evaluable disease amenable to repeated biopsies.
    6. Age ≥18 years.
    7. ECOG performance status 0 or 1.
    8. Life expectancy ≥3 months.
    9. Neither pregnant nor lactating.
    10. If of childbearing potential must agree to use adequate birth control for the duration of the study and for 30 days following the last dose of study drug. Negative pregnancy test within 7 days prior to registration.
    11. Absolute neutrophil count ≥1500/μL; platelets ≥100,000/μL; serum creatinine ≤ ULN; total bilirubin ≤1.5x ULN; AST/ALT ≤2.5x ULN; serum magnesium and potassium within normal limits (may use supplements to achieve normal values).
    12. Subjects must agree to two biopsies following their diagnostic biopsy – a pre- and a post- therapy biopsy.
    13. Able to provide informed consent and to follow protocol requirements.
    E.4Principal exclusion criteria
    1. Prior or concurrent systemic anticancer therapy.
    2. Prior w thdrawal from hormone replacement therapy ≤ 3 months previously.
    3. Prior or concurrent ipsilateral radiation therapy for invasive or non-invasive breast cancer.
    4. Evidence of distant metastatic disease (beyond adjacent nodes).
    5. Inflammatory breast cancer.
    6. Use of investigational agent(s) within 14 days prior to the first dose of study drug.
    7. History of cardiac disease with a New York Heart Association Class II or greater congestive heart failure, myocardial infarction or unstable angina in the past 6 months prior to Day 1 of treatment, or serious arrhythmias requiring medication for treatment.
    8. Known infection with human immunodeficiency virus, hepatitis B, or hepatitis C.
    9. Subjects with prolonged QTc interval >450 seconds.
    10. Known history of GI bleeding, ulceration, or perforation.
    11. Subjects receiving regular warfarin.
    12. Known history of stroke or cerebrovascular accident within the past 6 months.
    13. Any uncontrolled condition which in the opinion of the Investigator could affect the subject’s participation in the study.
    E.5 End points
    E.5.1Primary end point(s)
    Changes in levels of Ki-67 and AcH3 as determined by immunohistochemical analysis in paired pre- and post-treatment tumour biopsy specimens, indicative of CUDC-101 pharmacodynamic activity.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Screening visit (Day -14 to Day 1) and Day 5
    E.5.2Secondary end point(s)
    1. PK endpoints including clearance (Cl), apparent volume of distribution at steady state (Vdss), maximum concentration (Cmax), time of maximum concentration (Tmax), half-life (t1/2), area under the curve (AUC0-inf and AUC0-t), and other relevant parameters. Analysis of the PK parameters will include descriptive statistics such as means, standard deviations, median, maxima, and minima.
    2. Incidence of adverse events (CTCAE v.4) and changes from baseline in vital signs, clinical laboratory, and electrocardiography (ECG) parameters.
    3. Change in size of lesions measurable by physical examination (i.e., superficial and ≥10mm diameter as assessed using callipers).
    4. Changes in other biomarkers in indicative of CUDC-101 pharmacodynamic activity, such as IHC levels of pHER2, total HER2, pEGFR and EGFR in tumour tissue and AcH3 in PBMCs.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. PK: 0-23 hours post dose
    2. AEs throughout study
    3. Size of lesions: at screening visit and end of study visit.
    4. Other biomarkers: Cohort 1: at screening visit and Day 5; Cohort 2: at screening visit and Day 1
    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 Yes
    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 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) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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 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 months4
    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: 15
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    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 state20
    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)
    Normal treatment for condition
    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 Decision2012-09-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-12-11
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2012-11-30
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