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    Summary
    EudraCT Number:2013-002505-62
    Sponsor's Protocol Code Number:STH16404
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-12-05
    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 ConcernedUK - MHRA
    A.2EudraCT number2013-002505-62
    A.3Full title of the trial
    SarCaBon: A randomised phase II trial of Saracatinib versus placebo for cancer-induced bone pain
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical trial using Saracatinib versus placebo for cancer-induced bone pain
    A.3.2Name or abbreviated title of the trial where available
    SarCaBon: Saracatinib versus placebo for cancer-induced bone pain
    A.4.1Sponsor's protocol code numberSTH16404
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02085603
    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 SponsorSheffield Teaching Hospitals NHS Foundation Trust
    B.1.3.4CountryUnited Kingdom
    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 supportMRC
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSheffield Teaching Hospitals NHS Foundation Trust
    B.5.2Functional name of contact pointAimee Card
    B.5.3 Address:
    B.5.3.1Street AddressClinical Research Office, Room D49, D Floor, Royal Hallamshire Hospital, Glossop Road,
    B.5.3.2Town/ citySheffield
    B.5.3.3Post codeS10 2JF
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number01142265935
    B.5.5Fax number01142265937
    B.5.6E-mailaimee.card@sth.nhs.uk
    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 nameSaracatinib
    D.3.2Product code AZD0530
    D.3.4Pharmaceutical form Film-coated 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 INNSaracatinib
    D.3.9.1CAS number 379231-04-6
    D.3.9.2Current sponsor codeAZD0530
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number125
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Cancer-induced bone pain
    E.1.1.1Medical condition in easily understood language
    Cancer-induced bone pain arises from bone metastases (spread of malignant tumour from original site). For example breast and prostate cancer do have a tendency to spread to bone. Bone metastases can
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level LLT
    E.1.2Classification code 10049038
    E.1.2Term Metastatic bone pain
    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
    Is Saracatinib effective at reducing bone pain in cancer patients that have painful bone metastases by comparing patient’s self-reported pain ratings (0 – 10 point scale) after 4 weeks on treatment with pain scores from patients who receive placebo.
    E.2.2Secondary objectives of the trial
    1 Does concomitant analgesic usage decrease when patients are on Saracatinib?

    2.Do pain thresholds at symptomatic sites increase after treatment with Saracatinib?

    3.Are pain-related symptoms and quality of life improved by saracatinib as shown using the BPI, QLQ-C30, BM-22 and GAPR questionnaires?

    4.Is bone turnover further reduced by Saracatinib in patients already taking bisphosphonates or denosumab?

    5.Is saracatinib use safe and acceptable in this patient population?

    6.Is capturing patient reported outcomes using a telephone based interactive voice response system acceptable to this group of patients?
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Able to give written informed consent and willing to follow the study protocol.
    2.Age ≥ 16 years.
    3.Cytologically or histologically confirmed solid tumours of known primary site with painful bone metastases and poor control of bone pain
    4.WHO performance status ≤ 2
    5.Average baseline pain score ≥ 4 and ≤ 9 on a 0-10 numerical scale recorded over at least two separate days
    6.Adequate baseline haematological, hepatic and renal function, defined as follows:
    Absolute neutrophil count ≥ 1.5 x 109/L, Haemoglobin >9.0 g/dL (can be after transfusion), Platelet count ≥ 100 x 109/L, Bilirubin ≤ 1.5 x ULN, ALT or AST ≤ 2.5 x ULN (≤ 5 x ULN if liver metastases), Creatinine ≤ 1.5 x ULN,
    7.Ability to take and absorb oral medications.
    8.Female patients of childbearing potential (i.e. pre-menopausal females, females who have been menopausal for < 1 year and not surgically sterilized) must provide a negative pregnancy test (serum) ≤ 7 days before study treatment begins and must agree to practice effective contraceptive measures (oral contraceptive pill, intrauterine device or diaphragm with spemicide) plus condoms during the study and for 30 days after last dose of saracatinib.
    9.Male patients with a partner of child-bearing potential (who is not using an acceptable highly effective method of contraception) or a pregnant partner must use effective contraceptive measures (see 8) plus condoms during the study and for 3 months after the last dose of saracatinib. Patients should abstain from sperm donation during the study and for 3 months after the last dose of saracatinib.
    E.4Principal exclusion criteria
    1.Life expectancy < 3 months.
    2.Previous or planned radiotherapy at site of pain.
    3.Unstable cardiac disease in last 3 months.
    4.History of interstitial lung disease (bilateral, diffuse parenchymal lung disease) in view of known saracatinib-related pneumonitis.
    5.Unable to discontinue any medication with known moderate or potent inhibitory effect on CYP3A4, or is a substrate of CYP3A4.
    6.Concomitant cytotoxic chemotherapy unless established on maintenance treatment for > 6 weeks (not in a clinical trial).
    7.Unable to understand written or spoken English as the primary outcome is dependent on completion of the BPI-SF questionnaire.
    E.5 End points
    E.5.1Primary end point(s)
    The primary outcome will be whether the patients self-reported pain score is significantly lower than placebo after 4 weeks on treatment with saracatinib.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Target: Aug 2017 (Final Data Collection date for primary outcome measure)
    E.5.2Secondary end point(s)
    1.To determine if analgesic drug usage decreases when patients take saracatinib.
    2.To determine if pain thresholds at symptomatic sites increase after treatment with saracatinib.
    3.To determine if pain-related symptoms and quality of life are improved by saracatinib using the BPI, EORTC QLQ-C30, EORTC BM-22 and GAPR questionnaires.
    4.To determine whether bone turnover is further reduced by saracatinib in patients already taking bisphosphonates or denosumab.
    5.To determine the safety of saracatinib in this population by documenting a
    E.5.2.1Timepoint(s) of evaluation of this end point
    Target: Aug 2017 (Final Data Collection date for primary outcome measure)
    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 Information not present in EudraCT
    E.6.8Bioequivalence Information not present in EudraCT
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic Information not present in EudraCT
    E.6.12Pharmacoeconomic Information not present in EudraCT
    E.6.13Others Information not present in EudraCT
    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 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 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
    Recruitment complete, completion of CRFs and data queries for data lock.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days30
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days30
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 1
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 1
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 16
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 6
    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 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)
    Continuation supplies after the randomised intervention have not been made available for patients. We are hopeful that any benefits in pain experienced by patients may persist through the interruption of the pain cycle. Participants will also benefit from specific evaluation of their pain by expert clinicians and access to alternative standard pain interventions.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2013-11-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-10-24
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-01-24
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