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    The EU Clinical Trials Register currently displays   36631   clinical trials with a EudraCT protocol, of which   6048   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2012-002888-10
    Sponsor's Protocol Code Number:PCIA202/12
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2012-12-04
    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 ConcernedGermany - BfArM
    A.2EudraCT number2012-002888-10
    A.3Full title of the trial
    A Phase I/II Dose Escalation Study to Assess the Safety, Tolerability and Efficacy of Amphinex®-induced Photochemical Internalisation (PCI) of Gemcitabine Followed by Gemcitabine/Cisplatin Chemotherapy in Patients with Advanced Inoperable Cholangiocarcinomas
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to investigate the safety, tolerability and efficacy of PCI/Gemcitabine treatment followed by combination chemotherapy in patients with cholangiocarcinomas
    A.4.1Sponsor's protocol code numberPCIA202/12
    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 SponsorPCI Biotech AS
    B.1.3.4CountryNorway
    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 supportPCI Biotech AS
    B.4.2CountryNorway
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationTheradex (Europe) Ltd
    B.5.2Functional name of contact pointRegulatory Affairs
    B.5.3 Address:
    B.5.3.1Street Address2nd Floor, The Pinnacle, Station Way
    B.5.3.2Town/ cityCrawley
    B.5.3.3Post codeRH10 1JH
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+4401293510319
    B.5.5Fax number+4401293510322
    B.5.6E-mailmmoores@theradex.co.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 Yes
    D.2.5.1Orphan drug designation numberEU/3/16/1720
    D.3 Description of the IMP
    D.3.1Product nameAmphinex
    D.3.4Pharmaceutical form Solution for injection
    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 INNfimaporfin
    D.3.9.1CAS number 1443547-43-0
    D.3.9.2Current sponsor codeTPCS2a
    D.3.9.3Other descriptive nameAMPHINEX
    D.3.9.4EV Substance CodeSUB91568
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    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 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 Yes
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameGemcitabine
    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 INNGEMCITABINE
    D.3.9.1CAS number 95058-81-4
    D.3.9.4EV Substance CodeSUB07892MIG
    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
    Inoperable locally advanced cholangiocarcinomas
    E.1.1.1Medical condition in easily understood language
    Inoperable locally advanced cholangiocarcinomas
    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 10008594
    E.1.2Term Cholangiocarcinoma non-resectable
    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
    Phase I Dose Escalation
    • To determine a tolerable dose and safety profile of Amphinex-induced
    PCI of gemcitabine followed by systemic gemcitabine/cisplatin
    chemotherapy in patients with advanced inoperable cholangiocarcinoma

    Extended Part of Phase I
    • To determine the tolerability and safety profile of a two-administration
    schedule of Amphinex-induced PCI of gemcitabine followed by systemic
    gemcitabine/cisplatin chemotherapy in patients with advanced
    inoperable cholangiocarcinoma

    Phase II
    • To make a preliminary assessment of the efficacy of Amphinex-induced
    PCI of gemcitabine followed by systemic gemcitabine/cisplatin
    chemotherapy in patients with advanced inoperable cholangiocarcinoma
    E.2.2Secondary objectives of the trial
    Phase I Dose Escalation
    • To characterise the pharmacokinetic profiles of Amphinex and
    gemcitabine
    • To make a preliminary assessment of the efficacy of Amphinex-induced
    PCI of gemcitabine followed by systemic gemcitabine/cisplatin
    chemotherapy in patients with advanced inoperable cholangiocarcinoma

    Extended Part of Phase I
    • To characterise the pharmacokinetic profiles of Amphinex and
    gemcitabine
    • To make a preliminary assessment of the efficacy of a twoadministration
    schedule of Amphinex-induced PCI of gemcitabine
    followed by systemic gemcitabine/cisplatin chemotherapy in patients
    with advanced inoperable cholangiocarcinoma

    Phase II
    • To characterise the pharmacokinetic profile of Amphinex
    • To further assess the safety and efficacy profile of Amphinex-induced
    PCI of gemcitabine followed by the systemic gemcitabine/cisplatin
    combination
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Histopathologically/cytologically (C5) verified adenocarcinoma
    consistent with cholangiocarcinoma.
    2. Cholangiocarcinoma that:
    A) Is considered to be inoperable
    B) Has a primary lesion in the perihilar biliary duct region that requires
    stent placement
    C) Has nodal enlargement ≤to N1 as per computed
    tomography/magnetic resonance imaging assessment
    D) If has metastatic disease, this should be confined to the liver
    parenchyma only
    3. Adequate biliary drainage (either at least 50% of the liver volume, or
    at least two sectors), with no evidence of active uncontrolled infection
    (patients on antibiotics are eligible)
    4. Age ≥18 years
    5. The Eastern Cooperative Oncology Group performance status ≤1
    6. Estimated life expectancy of at least 12 weeks
    7. Written informed consent
    E.4Principal exclusion criteria
    1. Any prior anti-cancer (either local or systemic) treatment for
    cholangiocarcinoma
    2. Patients with extra-hepatic metastatic cholangiocarcinoma
    3. Patients with a severe visceral disease other than
    cholangiocarcinoma.
    4. Patients with primary sclerosing cholangitis
    5. Patients with porphyria or hypersensibility to porphyrins
    6. Patients with an active second primary cancer, with exception of
    adequately treated basal cell carcinoma, squamous cell carcinoma or
    other non-melanomatous skin cancer, or in-situ carcinoma of the uterine
    cervix. An active second primary cancer is defined as one with a diseasefree
    interval of <5 years before registration/randomisation.
    7. Inability to undergo computed tomography or magnetic resonance
    imaging
    8. Current participation in any other interventional clinical trial
    9. Male patients not willing to use adequate contraception or female
    patients of childbearing potential not willing to use an effective form of
    contraception such as hormonal birth control, intrauterine device or
    double barrier method during PCI treatment and subsequent
    chemotherapy and for at least 6 months thereafter.
    10. Breast feeding women or women with a positive pregnancy test at
    baseline
    11. Inadequate bone marrow function:
    - Absolute neutrophil count: <1.5 x 109/L, or platelet count <100 x
    109/L or haemoglobin <6 mmol/L (transfusion allowed)
    12. Inadequate liver function, defined as:
    - Serum (total) bilirubin >2.5 x the upper limit of normal for the
    institution
    - Aspartate amino transferase or alanine amino transferase >3.0 x upper limit of normal (>5.0 x upper limit of normal if liver metastases are
    present)
    - Alkaline phosphatase levels >5.0 x upper limit of normal
    13. Inadequate renal function, defined as:
    - Creatinine clearance <60 mL/min
    14. Planned surgery, endoscopic examination or dental treatment in the
    first 30 days after PCI treatment
    15. Co-existing ophthalmic disease likely to require slit-lamp
    examination within the first 90 days after PCI treatment
    16. Clinically significant and uncontrolled cardiac disease including
    unstable angina, acute myocardial infarction within 6 months prior to
    baseline, congestive heart failure, and arrhythmia requiring therapy,
    with the exception of extra systoles or minor conduction abnormalities
    and controlled and well treated chronic atrial fibrillation
    17. Known allergy or sensitivity to photosensitisers
    18. Ataxia telangiectasia
    19. Evidence of any other medical conditions (such as psychiatric illness,
    infectious diseases, physical examination or laboratory findings) that
    may interfere with the planned PCI treatment, affect patient compliance
    or place the patient at high risk from treatment-related complications
    20. Significant hearing impairment
    21. Patients concurrently receiving phenytoin
    22. Patients defined as vulnerable according to French law (France only,
    also see Section 5.4
    E.5 End points
    E.5.1Primary end point(s)
    Phase I Dose Escalation (Safety)
    • Dose-limiting toxicities and the safety profile (adverse events,
    laboratory assessments and physical findings) of the Amphinex-induced
    PCI of gemcitabine followed by the gemcitabine/cisplatin combination

    Extended Part of Phase I (Safety)
    • Schedule-limiting toxicities and the safety profile (adverse events,
    laboratory assessments and physical findings) of a two-administration
    schedule of Amphinex-induced PCI of gemcitabine followed by systemic
    gemcitabine/cisplatin chemotherapy

    Phase II (Efficacy)
    • Progression-free survival, defined as the time from randomisation to
    documented disease progression (according to Response Evaluation
    Criteria in Solid Tumours [RECIST] 1.1 criteria) or death from any cause.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Please refer to study protocol
    E.5.2Secondary end point(s)
    Phase I Dose Escalation
    • Pharmacokinetic profile of Amphinex and gemcitabine in plasma
    • Progression-free survival, defined as the time from registration to
    documented disease progression (according to RECIST 1.1 criteria) or
    death from any cause
    • Best overall response

    Extended Part of Phase I
    • Pharmacokinetic profile of Amphinex and gemcitabine in plasma
    • Progression-free survival, defined as the time from registration to
    documented disease progression (according to RECIST 1.1 criteria) or death from any cause
    • Best overall response at 24 weeks

    Phase II
    • Overall response rate, calculated as the proportion of patients with a
    best overall response of confirmed complete response or partial
    response
    • Disease control rate, defined as the proportion of patients with best
    overall response of confirmed complete response, partial response or
    stable disease
    • Overall survival, calculated as the time from randomisation to the date
    of death from any cause
    • Best overall response
    • Pharmacokinetic profile of Amphinex in bile
    • Safety profile (adverse events, laboratory assessments and physical
    findings) of the Amphinex-induced PCI of gemcitabine followed by the
    gemcitabine/cisplatin combination, or the gemcitabine/cisplatin
    combination alone
    E.5.2.1Timepoint(s) of evaluation of this end point
    Please refer to study protocol
    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 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 No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    Dose escalation
    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 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 Yes
    E.8.2.3.1Comparator description
    PCI procedure + combination chemotherapy vs combination chemotherapy alone
    E.8.2.4Number of treatment arms in the trial2
    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 concerned13
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA20
    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 years6
    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 years6
    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: 18
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    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 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 state39
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 68
    F.4.2.2In the whole clinical trial 68
    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)
    Care will be at the Investigator's discretion
    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 Decision2013-02-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-02-19
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2019-02-21
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
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