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    The EU Clinical Trials Register currently displays   44338   clinical trials with a EudraCT protocol, of which   7368   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2018-002647-29
    Sponsor's Protocol Code Number:PCIA_203/18
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2020-05-12
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2018-002647-29
    A.3Full title of the trial
    A Multi-Centre, Randomised, Open-Label, Phase 2 Study to Assess the Safety, Tolerability and Efficacy of Fimaporfin-Induced Photochemical Internalisation of Gemcitabine Complemented by Gemcitabine/Cisplatin Chemotherapy Versus Gemcitabine/Cisplatin Alone in Patients With Inoperable Cholangiocarcinoma
    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 complemented by combination chemotherapy, compared to combination chemotherapy alone, in patients with bile duct cancer.
    A.4.1Sponsor's protocol code numberPCIA_203/18
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04099888
    A.5.4Other Identifiers
    Name:US INDNumber:128897
    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 organisationPPD
    B.5.2Functional name of contact pointRoberta Fumagalli - PM
    B.5.3 Address:
    B.5.3.1Street AddressSegreen Business Park, Via San Bovio 3
    B.5.3.2Town/ citySan Felice, Segrate, Milan
    B.5.3.3Post code20090
    B.5.3.4CountryItaly
    B.5.4Telephone number+3902210811
    B.5.5Fax number+39022152912
    B.5.6E-mailMilanFrontDesk.SM@ppdi.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 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.3.9.3Other descriptive nameFimaporfin di-olamine
    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 number26
    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.2.5The 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.3.4Pharmaceutical form
    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.3.9.3Other descriptive nameGEMCITABINE HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB02324MIG
    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 Cholangiocarcinoma
    E.1.1.1Medical condition in easily understood language
    Bile duct cancer that cannot be removed with surgery
    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 Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    - to assess the efficacy of fimaporfin induced PCI of gemcitabine complemented by systemic gemcitabine/cisplatin chemotherapy versus gemcitabine/cisplatin alone in patients with inoperable CCA by assessment of PFS
    E.2.2Secondary objectives of the trial
    1. To assess the longer-term efficacy in patients with inoperable CCA by assessment of OS;
    2. To further assess of best overall response (BOR), objective response rate (ORR), duration of response (DoR), disease control rate (DCR) at 6 and 12 months, and change in tumour size per Response Evaluation Criteria in Solid Tumours, version 1.1 (RECIST 1.1);
    3. To assess the effects of fimaporfin-induced PCI on safety in terms of loco regional tumour related events and biliary complications;
    4. To further assess the safety profile (adverse events [AEs], laboratory assessments, physical findings, and photosensitivity)
    5. To further characterise the pharmacokinetic (PK) profile of fimaporfin in plasma;
    6. To assess the health-related quality of life (HRQoL) and patient reported outcome (PRO) measures
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Capable of understanding the written informed consent, provides signed and witnessed written informed consent, and agrees to comply with protocol requirements;
    2. Male or female patient ≥18 years of age;
    3. Cholangiocarcinoma verified as adenocarcinoma by histopathology or cytology (C5) with a perihilar or distal stenosis that has been stented or will require stenting, and that is accessible for PCI light treatment;
    4. Cholangiocarcinoma must be considered inoperable with respect to radical resection (including partial liver resection or liver transplantation);
    5. At least 1 radiologically evaluable lesion (measurable and/or non-measurable) that can be assessed at baseline and is suitable for repeated radiological evaluation;
    6. If metastatic disease, metastasis must be limited to the liver parenchyma and/or local lymph nodes (within close proximity to the hepatoduodenal ligament);
    7. Adequate biliary drainage (either at least 50% of the liver volume, or at least 2 sectors), with no evidence of active uncontrolled infection (patients on antibiotics are eligible);
    8. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
    9. Estimated life expectancy of at least 12 weeks.
    E.4Principal exclusion criteria
    1. Previously received any anti-tumour (either local or systemic) treatment for CCA;
    2. Severe visceral disease other than CCA;
    3. A history of frequently recurring septic biliary events caused by non-malignant strictures (primary sclerosing cholangitis [PSC], autoimmune hepatitis or advanced chronic liver dysfunction);
    4. Porphyria or hypersensitivity to porphyrins;
    5. An active second primary cancer, defined as one with a disease-free interval of <5 years before screening, with the exception of adequately treated basal cell carcinoma, squamous cell carcinoma or other non-melanomatous skin cancer, in situ carcinoma of the uterine cervix, or prostate cancer that is controlled by hormone therapy (patients may continue hormone therapy while on study);
    6. Unable to undergo contrast-enhanced CT or MRI;
    7. Currently participating in any other interventional clinical study;
    8. Planned surgery, endoscopic examination, or dental treatment in the first 30 days after PCI treatment;
    9. Co-existing ophthalmic disease likely to require slit-lamp examination within the first 90 days after PCI treatment;
    10. 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;
    11. Known allergy or sensitivity to photosensitisers, (the active substance and/or any of the excipients); or chronic use of other photosensitising therapies (Section 5.5.3); treatment with amiodarone during the last 12 months;
    12. Known hypersensitivity to or contraindication to the use of gemcitabine (the active substance and/or any of the excipients);
    13. Known hypersensitivity, or contraindication to the use of cisplatin (the active substance and/or any of the excipients);
    14. Ataxia telangiectasia;
    15. Upon the Investigator’s discretion, evidence of any other medical conditions (such as psychiatric illness, 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;
    16. Significant hearing impairment;
    17. Plans to have, or has recently had, vaccination with a live vaccine, including for yellow fever;
    18. Concurrently receiving treatment with phenytoin;
    19. Male patients unwilling to use highly effective contraception or women of childbearing potential (WOCBP) unwilling to use a highly effective form of contraception such as the following:
    - Combined (oestrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal and transdermal)
    - Progestogen-only hormonal contraception associated with inhibition of ovulation12 (oral, injectable, or implantable)
    - Intrauterine devices
    - Intrauterine hormone-releasing system
    - Bilateral tubal ligation
    - Vasectomised partner
    - Sexual abstinence
    Patients must continue the use of contraception during PCI treatment and subsequent chemotherapy, and for at least 9 months after last dose of Amphinex or 6 months after last dose of chemotherapy, whichever is the latest.
    20. Breastfeeding women or women with a positive pregnancy test at baseline;
    21. Inadequate bone marrow function as evidenced by one of the following:
    - Absolute neutrophil count (ANC) <1.5 × 109/L
    - Platelet count <100 × 109/L
    - Haemoglobin <6 mmol/L (transfusion allowed);
    22. Inadequate liver function despite satisfactory endoscopic or percutaneous biliary tree stenting, defined as:
    - Serum (total) bilirubin persisting at >2.5 × the ULN for the institution
    - AST or ALT >3.0 × ULN (>5 × ULN if liver metastases are present)
    - ALP levels >5.0 × ULN;
    23. Inadequate renal function, as determined by local practice for patients on fractionated platinum-based chemotherapy. Patients with creatinine clearance <60 mL/min must not be included.
    E.5 End points
    E.5.1Primary end point(s)
    Progression free survival is defined as the time from randomisation until the date of objective disease progression or death (by any cause in the absence of progression) regardless of whether the patient withdraws from therapy or receives another anti-cancer therapy prior to progression.
    E.5.1.1Timepoint(s) of evaluation of this end point
    every 12 weeks
    E.5.2Secondary end point(s)
    Overall Survival: Overall survival (OS) is calculated as the time from randomisation to the date of death from any cause.
    Best Overall Response: The BOR is the best response recorded from the start of the treatment until disease progression/recurrence (using the smallest measurements recorded since the treatment started as reference for progressive disease).
    Objective Response Rate: The ORR is calculated as the proportion of patients with measurable disease at baseline who have at least one visit response with a CR or PR noted.
    Duration of Response: The DoR is defined as the time from the first documented tumour response until the first documented disease progression, or death in the absence of disease progression.
    Disease Control Rate: The DCR is defined as the proportion of patients with stable disease or better (CR, PR or SD); assessed at 6 and 12 months.
    E.5.2.1Timepoint(s) of evaluation of this end point
    every 12 weeks
    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 No
    E.6.11Pharmacogenomic Yes
    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 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 Yes
    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) Yes
    E.8.2.2Placebo No
    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 Yes
    E.8.5.1Number of sites anticipated in the EEA41
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Belgium
    Denmark
    Finland
    France
    Germany
    Italy
    Korea, Republic of
    Norway
    Poland
    Spain
    Sweden
    Taiwan
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee Yes
    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 years3
    E.8.9.1In the Member State concerned months1
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months2
    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: 49
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 137
    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 state
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 128
    F.4.2.2In the whole clinical trial 186
    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 Decision
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion
    P. End of Trial
    P.End of Trial StatusCompleted
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