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    Summary
    EudraCT Number:2014-005095-28
    Sponsor's Protocol Code Number:IRST186.02
    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:2016-03-08
    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 number2014-005095-28
    A.3Full title of the trial
    Olaparib as salvage treatment for cisplatin-resistant germ cell tumor.
    Olaparib as salvage treatment for cisplatin-resistant germ cell tumor.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Olaparib as salvage treatment for cisplatin-resistant germ cell tumor.
    Olaparib come trattamento di salvataggio per tumore a cellule germinali cisplatino-resistenti.
    A.3.2Name or abbreviated title of the trial where available
    Olaparib as salvage treatment for cisplatin-resistant germ cell tumor.
    Olaparib come trattamento di salvataggio per tumore a cellule germinali cisplatino-resistenti.
    A.4.1Sponsor's protocol code numberIRST186.02
    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 SponsorISTITUTO SCIENTIFICO ROMAGNOLO PER LO STUDIO E LA CURA DEI TUMORI (IRST) S.R.L. IRCCS
    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 supportAzienda Farmaceutica: AstraZeneca SpA - Italia
    B.4.2CountryItaly
    B.4.1Name of organisation providing supportAltro: IRST IRCCS - Italia
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationIRCCS IRST
    B.5.2Functional name of contact pointCentro di Coordinamento Studi IRST
    B.5.3 Address:
    B.5.3.1Street AddressDipartimento di Oncologia ed Ematologia, Ospedale Civile S. Maria delle Croci, viale Randi, 5
    B.5.3.2Town/ cityRavenna
    B.5.3.3Post code48121
    B.5.3.4CountryItaly
    B.5.4Telephone number+39 0544 285813
    B.5.5Fax number+39 0544 285330
    B.5.6E-mailcc.ubsc@irst.emr.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 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 numberAZD2281
    D.3 Description of the IMP
    D.3.1Product nameOLAPARIB_IRSTIRCCS
    D.3.2Product code OLAPARIB_IRSTIRCCS
    D.3.4Pharmaceutical form 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 INNOLAPARIB_IRSTIRCCS
    D.3.9.1CAS number 763113-22-0
    D.3.9.2Current sponsor codeOLAPARIB_IRSTIRCCS
    D.3.9.3Other descriptive nameOLAPARIB
    D.3.9.4EV Substance CodeSUB32234
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number300
    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
    cisplatin-resistant germ cell tumor
    tumore a cellule germinali cisplatino-resistenti
    E.1.1.1Medical condition in easily understood language
    cisplatin-resistant germ cell tumor
    tumore a cellule germinali cisplatino-resistenti
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level PT
    E.1.2Classification code 10061184
    E.1.2Term Germ cell 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 evaluate the preliminary activity of Olaparib in GCT (Germ Cell Tumors).
    valutare l'attività di Olaparib nei tumori a cellule germinali.
    E.2.2Secondary objectives of the trial
    - To evaluate the safety, PFS (Progression Free Survival) and OS (Overall Survival) of patients with cisplatin-refractory GCT receiving Olaparib
    - To identify predictive biomarkers (in paraphin-embedded tumor samples and/or plasma) clinical outcome (ORR (Overall Response Rate), PFS, OS)
    - Valutare la sicurezza, PFS (sopravvivenza libera da progressione) e OS (sopravvivenza globale) dei pazienti con con tumore germinale refrattari al cisplatino che assumono Olaparib
    - Identificare biomarcatori predittivi (in campioni tumorali paraffinati e / o plasma) dell'esito clinico (ORR (tasso di risposta globale), PFS, OS).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patients ≥ 18 years old
    2. Histologically verified metastatic gonadal GCT or extragonadal GCT originating from retroperitoneum or mediastinum
    3. Disease progression during cisplatin-based chemotherapy or disease progression or relapse after high-dose chemotherapy or disease progression or relapse after at least 2 different cisplatin-based regimens
    4. patients who progressed during cisplatin-based therapy and who are not eligible for high-dose chemotherapy
    5. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS): 0-2
    6. Life expectancy ≥3 months
    7. At baseline adequate function of liver, kidneys and bone marrow
    8. Signed informed consent and expected cooperation of the patients for the treatment and follow up
    9. At least one measurable lesion that can be accurately assessed by CT/MRI/plain x-ray) at baseline and follow up visits.
    1. pazienti ≥ 18 anni
    2. conferma istologica di GCT gonadico metastatico o GCT extragonadico proveniente da retroperitoneo o mediastino
    3. Progressione della malattia durante la chemioterapia a base di cisplatino o progressione della malattia o recidiva dopo chemioterapia ad alte dosi o progressione della malattia o recidiva dopo almeno 2 diversi regimi a base di cisplatino
    4. pazienti in progressione durante la terapia a base di cisplatino e che non sono candidabili ad una chemioterapia ad alte dosi
    5. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS): 0-2
    6. aspettativa di vita ≥3 mesi
    7. adeguate funzionalità di fegato, reni e midollo osseo al basale.
    8. firma del consenso informato e prevista cooperazione del paziente per il trattamento ed il follow-up
    9. Almeno una lesione misurabile che può essere valutata con precisione mediante TC / RM / plain x-ray) al basale ed alle visite di follow-up.
    E.4Principal exclusion criteria

    1. Systemic antitumor treatment within 21 days before study entry
    2. Simultaneous radiotherapy to the only target lesion
    3. Patients with resting ECG with QTc > 470 msec detected on 2 or more time points within a 24 hour period or family history of long QT syndrome. If ECG demonstrates QTc >470 msec, patient will be eligible only if repeat ECG demonstrates QTc ≤470 msec
    4. Patients who have experienced a seizure or seizures within 6 months of study treatment or who are currently being treated with cytochrome P450 enzyme inducing anti-epileptic drugs for seizures.
    5. Patients with uncontrolled brain metastases.
    6. Patients receiving prohibited classes of inhibitors of CYP3A4.
    7. Patients with gastrointestinal disorders likely to interfere with absorption of the study medication.
    8. Patients with any acute toxicities due to previous cancer treatment that have not resolved to a NCI-CTCAE v 4.03 grade 0 or 1 with the exception of chemotherapy induced alopecia and grade 2 peripheral neuropathy.
    9. Patients affected by myelodysplastic syndrome or acute myeloid leukemia
    10. Known to be serologically positive for HIV and receiving antiretroviral therapy
    11. Known seropositive for active viral infection with hepatitis B virus (HBV) (patients who are HBsAg negative, anti-HBs positive and/or Anti-HBc positive, but viral DNA negative are eligible)
    12. Known seropositive for active infection with hepatitis C virus (HCV)
    13. Patients unwilling or unable to comply with the protocol
    14. Patients with unstable angina pectoris, myocardial infarction ≤ 6 months prior to first study treatment, congestive heart failure NYHA III-IV or serious uncontrolled cardiac arrhythmias
    15. Patients with an active or uncontrolled infection
    16. Patients who have a history of another primary malignancy and are off treatment for ≤ 3 years, with the exception of non-melanoma skin cancer
    17. Patients who have undergone major surgery within 4 weeks prior to starting study drug (e.g. intra-thoracic, intra-abdominal, or intra-pelvic) or significant traumatic injury, or who have not recovered from the side effects of any of the above within 6 weeks
    18. Patients who have participated in another interventional clinical trial within 30 days before study entry
    19. Other serious medical conditions that could impair the ability of the patient to participate in the study
    20. Active infection requiring systemic antibiotic-, anti-viral-, or anti-fungal medication
    21. Active cancer (other than GCT) including prior malignancy from which the patient has been disease-free for ≤3 years (except superficial basal cell skin cancer)
    22. Patients with a known hypersensitivity to the combination/comparator agent
    23. Patients with uncontrolled seizures.
    1. trattamento antitumorale sistemico entro 21 giorni prima dell'ingresso nello studio
    2. radioterapia simultanea verso la sola lesione target per lo studio
    3. pazienti con ECG a riposo con QTc> 470 msec rilevato in 2 o più tempi entro un periodo di 24 ore o storia familiare di sindrome del QT lungo. Se l'ECG mostra un QTc> 470 msec, il paziente sarà eligibile solo se all'ECG ripetuto mostrerà QTc ≤470 msec
    4. pazienti che hanno avuto uno o più episodi di convulsioni entro 6 mesi dal trattamento in studio o che sono attualmente in trattamento con farmaci antiepilettici induttori dell'enzima citocromo P450 per le convulsioni.
    5. pazienti con metastasi cerebrali incontrollate.
    6. pazienti che assumono farmaci appartenenti alle classi di inibitori di CYP3A4 vietati.
    7. pazienti con disturbi gastrointestinali che possono interferire con l'assorbimento del farmaco in studio.
    8. Pazienti con qualsiasi tossicità acuta dovuta a precedenti trattamenti oncologici che non si è risolta al grado 0 o 1 NCI-CTCAE v 4.03, ad eccezione dell'alopecia e della neuropatia periferica di grado 2 indotte dalla chemioterapia.
    9. pazienti affetti da sindrome mielodisplastica o leucemia mieloide acuta
    10. pazienti con positività sierologica per l'HIV che assumono terapia antiretrovirale
    11. pazienti sieropositivi per l'infezione virale attiva da epatite B (HBV) (i pazienti HBsAg negativi, anti-HBs positivi e / o anti-HBc positivi, ma con DNA virale negativo sono eligibili)
    12. pazienti sieropositivi per l'infezione attiva da virus dell'epatite C (HCV)
    13. pazienti che non vogliono o non in grado di rispettare il protocollo
    14. pazienti con angina pectoris instabile, infarto miocardico da meno di 6 mesi prima del trattamento dello studio, insufficienza cardiaca congestizia NYHA III-IV o gravi aritmie cardiache non controllate
    15. pazienti con infezione attiva o non controllata
    16. pazienti che hanno una storia di un altro tumore maligno primario e che hanno terminato la terapia da meno di 3 anni, con l'eccezione del cancro della pelle non-melanoma
    17. pazienti che hanno subito interventi di chirurgia maggiore entro 4 settimane prima di iniziare il farmaco in studio (ad es. intratoracica,
    intra-addominale, o intra-pelvica) o una significativa lesione traumatica, o che non hanno recuperato dagli effetti collaterali di una di queste entro 6 settimane
    18. pazienti che hanno partecipato ad un altro studio clinico interventistico entro 30 giorni prima dell'ingresso nello studio
    19. Altre condizioni mediche gravi che potrebbero compromettere la capacità del paziente di partecipare allo studio
    20. Infezione attiva che richiede antibiotico sistemico, farmaci anti-virali o anti-funginei
    21. tumore attivo (diverso da GCT) compresi precedenti neoplasie da cui il paziente è libero da malattia da meno di 3 anni (ad eccezione del cancro della pelle delle cellule basali superficiali)
    22. pazienti con nota ipersensibilità al farmaco in studio
    23. pazienti con convulsioni non controllate.
    E.5 End points
    E.5.1Primary end point(s)
    to evaluate the preliminary activity of Olaparib in GCT (Germ Cell Tumors).
    valutare l'attività di Olaparib nei tumori a cellule germinali.
    E.5.1.1Timepoint(s) of evaluation of this end point
    30 months
    30 mesi
    E.5.2Secondary end point(s)
    1)To evaluate the safety, PFS (Progression Free Survival) and OS (Overall Survival) of patients with cisplatin-refractory GCT receiving Olaparib.
    2)To identify predictive biomarkers (in paraphin-embedded tumor samples and/or plasma) clinical outcome (ORR (Overall Response Rate), PFS, OS)
    1)Valutare la sicurezza, PFS (sopravvivenza libera da progressione) e OS (sopravvivenza globale) dei pazienti con con tumore germinale refrattari al cisplatino che assumono Olaparib. 2)Identificare biomarcatori predittivi (in campioni tumorali paraffinati e / o plasma) dell'esito clinico (ORR (tasso di risposta globale), PFS, OS).
    E.5.2.1Timepoint(s) of evaluation of this end point
    30 months
    30 mesi
    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 Yes
    E.6.13.1Other scope of the trial description
    To identify predictive biomarkers (in paraphin-embedded tumor samples and/or plasma) clinical outcome (ORR (Overall Response Rate), PFS, OS).
    Identificare biomarcatori predittivi (in campioni tumorali paraffinati e / o plasma) dell'esito clinico (ORR (tasso di risposta globale), PFS, OS).
    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 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 No
    E.8.2.4Number of treatment arms in the trial1
    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 concerned2
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months30
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months30
    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: 28
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 1
    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 state29
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 29
    F.4.2.2In the whole clinical trial 29
    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)
    Data collection at follow-up (every 6 weeks ± 2 weeks):
    • Physical examination (weight, height, resting pulse and blood pressure).
    • Blood sample for standard clinical chemistry and hematology
    • Documentation of antitumor treatment
    • CT scan or MRI of chest/abdomen (in patients without documented progressive disease)
    Ogni 6 settimane ± 2 settimane avverrà la raccolta dei dati al follow-up:
    • Esame fisico (peso, l'altezza, frequenza cardiaca e pressione arteriosa).
    • Prelievi ematici di chimica clinica ed ematologia
    • Documentazione del trattamento antitumorale
    • TAC o RMN del torace / addome (in pazienti senza progressione di malattia documentata)
    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 Decision2015-03-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-04-16
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2023-02-13
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