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    Summary
    EudraCT Number:2020-002949-42
    Sponsor's Protocol Code Number:PACT-29
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-05-24
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2020-002949-42
    A.3Full title of the trial
    A pilot study of chlorambucil in pre-treated metastatic pancreatic adenocarcinoma patients bearing a germ line BRCA or other DNA Defects Repair (DDR) mutations.
    Studio pilota sul clorambucile nel trattamento di pazienti affetti da adenocarcinoma del pancreas metastatico già precedentemente trattati e portatori di una mutazione germinale BRCA o di altre mutazioni riguardanti i geni coinvolti nel riparo del DNA (mutazioni DDR).
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study on chlorambucil efficacy in patients with metastatic pancreatic adenocarcinoma already undergoing previous chemotherapy treatment and carriers of a BRCA mutation or other mutations concerning the genes involved in DNA repair.
    Studio sull’efficacia del trattamento del clorambucile in pazienti affetti da adenocarcinoma del pancreas metastatico già sottoposti a precedente trattamento chemioterapico e portatori di una mutazione BRCA o di altre mutazioni riguardanti i geni coinvolti nel riparo del DNA.
    A.3.2Name or abbreviated title of the trial where available
    SALE
    SALE
    A.4.1Sponsor's protocol code numberPACT-29
    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 SponsorOSPEDALE SAN RAFFAELE
    B.1.3.4CountryItaly
    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 supportFondi Liberi dell' Oncologia Medica dell'Ospedale San Raffaele
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationOspedale San Raffaele
    B.5.2Functional name of contact pointOncologia Medica
    B.5.3 Address:
    B.5.3.1Street AddressVia Olgettina, 60
    B.5.3.2Town/ cityMilano
    B.5.3.3Post code20132
    B.5.3.4CountryItaly
    B.5.4Telephone number0226437644
    B.5.5Fax number0226436521
    B.5.6E-mailreni.michele@hsr.it
    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 Yes
    D.2.1.1.1Trade name LEUKERAN - 2 MG COMPRESSE RIVESTITE CON FILM 25 COMPRESSE
    D.2.1.1.2Name of the Marketing Authorisation holderASPEN PHARMA TRADING LIMITED
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 nameLeukeran
    D.3.2Product code [024790026]
    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 INNClorambucile
    D.3.9.1CAS number 305-03-3
    D.3.9.2Current sponsor codeNA
    D.3.9.4EV Substance CodeSUB06172MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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 affected by metastatic pancreatic adenocarcinoma (PDAC).
    Pazienti affetti da adenocarcinoma del pancreas (PDAC) metastatico.
    E.1.1.1Medical condition in easily understood language
    Metastatic pancreatic adenocarcinoma patients
    Pazienti con tumore del pancreas in stadio avanzato (metastatico).
    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 PT
    E.1.2Classification code 10052747
    E.1.2Term Adenocarcinoma pancreas
    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
    Evaluate the proportion of patients who are progression-free (defined as progression according to RECIST 1.1 criteria, or death) at 6 months (PFS-6) from registration into the trial.
    Valutare quanti pazienti sono liberi da progressione (definita come progressione secondo i criteri RECIST 1.1 o morte) della patologia a 6 mesi (PFS-6) dalla registrazione allo studio clinico
    E.2.2Secondary objectives of the trial
    -Overall survival (OS), defined as time between the date of registration and the date of death for any cause or the date they were last known to be alive.
    -PFS, defined as the time between the date of registration and the date of documented radiological PD according to RECIST 1.1 criteria or death from any cause, whichever occurs first, or the date of last follow-up or last available tumor assessment if no further follow-up for disease progression is performed.
    -RECIST radiological response rate.
    -CA19-9 response rate.
    -Safety
    -Sopravvivenza complessiva (OS), definita come il tempo intercorso tra la data dell’arruolamento del paziente e la morte del paziente per qualsiasi causa o l’ultima volta in cui il paziente è stato visto in vita
    -La sopravvivenza libera da malattia (PFS), definito come il tempo intercorso tra la data dell’arruolamento del paziente e la data dell’evidenza radiologica di progressione secondo i criteri RECIST 1.1 o morte del paziente, se questa sopraggiunge per prima
    -La risposta radiologica secondo criteri RECIST
    -La risposta del marcatore Ca19.9
    -Tossicità
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Pathologically confirmed pancreatic adenocarcinoma
    2) Age = 18 years
    3) ECOG PS 0-2
    4) Stage IV disease
    5) Identified genetic aberrations that are associated with homologous recombination deficiency (HRD)
    a) Cohort A: Documented mutation in gBRCA1 or gBRCA2 that is predicted to be deleterious or suspected deleterious
    b) Cohort B: BRCA1 or BRCA2 mutations that are considered to be of uncertain/unknown significance (VUS)
    c) Cohort C: Patients with other identified genetic aberrations that are associated with HRD
    6) adequate PFS during previous platinum-based chemotherapy for at least 4 months before progression
    7) Screening laboratory values:
    Leukocytes > 3000/mmc
    Thrombocytes > 150000/mmc
    Hemoglobin > 10 g/dl
    Creatinine <2.0 times upper normal limit (unless normal creatinine clearance).
    Total bilirubin <2.0 times upper normal limit (unless due to Gilbert's syndrome).
    Alanine aminotransferase (ALT) <3.0 times upper normal limit
    8) Able to take oral medication
    9) Progression during or after platinum-based chemotherapy
    10) Other prior chemotherapy apart from first-line treatment for pancreatic cancer, are allowed, including maintenance treatment with PARP inhibitors
    11) More than 2 weeks since prior chemotherapy end
    12) Signed written informed consent
    13) QTc <450 msec or QTc <480 msec for patients with bundle branch block
    1) Diagnosi confermata di adenocarcinoma del pancreas (PDAC)
    2) Età =18 anni
    3) ECOG PS 0-2
    4) Malattia dello stadio IV
    5) Aberrazioni genetiche della capacità di ricombinazione omologa (HRD):
    i. Coorte A: Mutazione gBRCA1 o gBRCA2
    ii. Coorte B: Mutazione gBRCA1 o gBRCA2 di incerto significato (VUS)
    iii. Coorte C: Altre mutazioni associate a geni coinvolti nel riparo del DNA
    6) PFS adeguato durante la precedente chemioterapia a base di platino per almeno 4 mesi prima della progressione
    7) Valori di laboratorio allo screening:
    Leucociti > 3000/mmc
    Piastrine > 150000/mmc
    Emoglobina > 10 g/dl
    Creatinina < 2,0 volte il limite superiore di normalità
    Totale bilirubina < 2,0 volte il limite superiore di normalità (a meno che non sia dovuto alla sindrome di Gilbert).
    ALT < 3,0 volte il superiore di normalità.
    8) Capacità di assumere farmaci orali
    9) Progressione durante o dopo chemioterapia a base di platini
    10) Sono ammesse altre chemioterapia oltre al trattamento di prima linea per il cancro al pancreas, compreso il trattamento di mantenimento con inibitori PARP
    11) Più di 2 settimane dalla fine della chemioterapia precedente
    12) Consenso informato scritto firmato
    13) QTc <450 msec o QTc <480 msec per pazienti con blocco branchiale
    E.4Principal exclusion criteria
    1) Clinically significant cardiac disease including unstable angina, acute myocardial infarction within 6 months prior to screening, congestive heart failure, and arrhythmia requiring therapy, with the exception of extra systoles or minor conduction abnormalities
    2) Active and uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy
    3) Vaccination with vaccines called “live”, since this treatment causes a drop of immunity defenses and a serious infection could result fatal.
    4) History of seizure, head trauma and treatment with anti-epileptogenic drugs
    5) Hypersensitivity to chlorambucil or to any excipients, in particular lactose
    6) BRCA-mutated advanced pancreatic cancer who did not undergo maintenance with olaparib after platinum-based chemotherapy
    7) Mismatch repair (MMR)/high levels of microsatellite instability (MSI-H), or high levels of tumor mutational burden (TMB) pancreatic cancer who did not undergo immunotherapy with pembrolizumab monotherapy or any other anti-PD1 agent
    8) Concomitant PARP inhibitors therapy
    9) Life expectancy less than 3 months, in the opinion of the investigator
    10) Other past or current malignancy. Subjects who have been free of malignancy for at least 5 years, or have a history of completely resected non-melanoma skin cancer, or successfully treated in situ carcinoma are eligible
    11) Symptomatic duodenal stenosis
    12) Any significant medical condition laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study
    13) Any condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study
    14) Any condition that confounds the ability to interpret data from the study
    15) Any familiar, sociologic or geographic conditions that can potentially interfere with the adhesion to the protocol or to the follow-up
    16) Pregnant or nursing. Adequate contraception is defined as oral hormonal birth control, intrauterine device, and male partner sterilization
    17) Concurrent treatment with other experimental drugs
    1) Malattia cardiaca clinicamente significativa tra cui angina instabile, infarto miocardico acuto entro 6 mesi prima dello screening, insufficienza cardiaca congestizia e aritmia che richiedono terapia, ad eccezione di sistoli extra o anomalie di conduzione minori
    2) Infezioni batteriche, virali o fungine attive e incontrollate che richiedono una terapia sistemica
    3) Terapia con vaccini chiamati “vivi”, che possono abbassare le difese immunitarie e causare infezioni vitali che possono risultare fatali
    4) Storia di traumi cerebrali e trattamento con farmaci anti-epilettici
    5) Allergia al clorambucile o ad altri eccipienti, in particolare lattosio
    6) Pazienti BRCA-mutati che dopo una chemioterapia a base di platino non sono stati trattati con olaparib di mantenimento
    7) Pazienti che presentano un Mismatch repair (MMR) o alti livelli di instabilità da microsatellite (MSI-H), or alti livelli di tumor mutational burden (TMB) che non vanno incontro a immunoterapia con il pembrolizumab o con altri agenti anti-PD1
    8) Terapia concomitante con gli inibitori di PARP
    9) Aspettativa di vita inferiore a 3 mesi, secondo l'investigatore
    10) Altro tumore maligno in passato o attuale. Sono idonei soggetti che sono stati privi di malignità da almeno 5 anni o che hanno una storia di cancro della pelle (non melanoma) completamente risolta o trattata con successo in situ carcinoma
    11) Stenosi duodenale sintomatica
    12) Qualsiasi condizione medica significativa, anomalia di laboratorio o malattia psichiatrica che impedirebbe al soggetto di partecipare allo studio
    13) Qualsiasi condizione, compresa la presenza di anomalie di laboratorio, che pone il soggetto a rischio inaccettabile se dovesse partecipare allo studio
    14) Qualsiasi condizione che confonda la capacità di interpretare i dati dello studio
    15) Qualsiasi condizione familiare, sociologica o geografica che possa interferire con l'adesione al protocollo o al follow-up
    16) Gravidanza o allattamento.
    17) Trattamento simultaneo con altri farmaci sperimentali
    E.5 End points
    E.5.1Primary end point(s)
    Evaluate the proportion of patients who are progression-free at 6 months (PFS-6)
    Valutare quanti pazienti sono liberi da progressione della patologia a 6 mesi (PFS-6)
    E.5.1.1Timepoint(s) of evaluation of this end point
    6 months
    6 mesi
    E.5.2Secondary end point(s)
    Overall survival (OS); The progression free survival (PFS); RECIST radiological response rate.; Ca19.9 response rate.; Safety
    Sopravvivenza complessiva (OS); La progressione libera da malattia (PFS); La risposta radiologica secondo criteri RECIST.; La risposta del marcatore Ca19.9.; Sicurezza
    E.5.2.1Timepoint(s) of evaluation of this end point
    3 years; 3 years; until drug unacceptable toxicity or medical decision.; until drug unacceptable toxicity or medical decision.; until drug unacceptable toxicity or medical decision.
    3 anni; 3 anni; fino a tossicità intollerabile al farmaco o decisione medica.; fino a tossicità intollerabile al farmaco o decisione medica.; fino a tossicità intollerabile al farmaco o decisione medica.
    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 No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    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) 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 No
    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 Yes
    E.8.1.7.1Other trial design description
    Studio in Aperto
    Unblinded trial
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    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 Information not present in EudraCT
    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
    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 months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months0
    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: 20
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 30
    F.4.2.2In the whole clinical trial 30
    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)
    For patients who will be progressing, a new line of therapy will be planned if necessary.
    Per i pazienti che andranno incontro a progressione verrà programmata eventualmente una nuova linea di terapia.
    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 Decision2020-11-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-09-16
    P. End of Trial
    P.End of Trial StatusOngoing
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