Clinical trial • Phase II • Oncology

OLAPARIB for BRCA wild-type advanced ovarian cancer | Fallopian tube cancer | Primary peritoneal cancer

Phase II trial of OLAPARIB for BRCA wild-type advanced ovarian cancer | Fallopian tube cancer | Primary peritoneal cancer.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
BRCA wild-type advanced ovarian cancer | Fallopian tube cancer | Primary peritoneal cancer
Trial Stage
Phase II
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
04-11-2024
First CTIS Authorization Date
09-12-2024

Trial design

open-label, none/not specified-controlled Phase II trial across 45 sites in Italy.

Open Label
Yes
Comparator
None/Not specified
Target Sample Size
200

Eligibility

Recruits 200 The record indicates isVulnerablePopulationSelected = true. The protocol requires signed informed consent obtained prior to initiation of any study-specific procedures. Subjects are adult females (≥18); no procedures for assent or parental consent are described (minors are excluded). Subject information and informed consent forms are provided in the document list..

Pregnancy Exclusion
Postmenopausal or evidence of non-childbearing status for women of childbearing potential: negative urine or serum pregnancy test within 28 days of study treatment and confirmed prior to treatment on day 1.
Vulnerable Population
The record indicates isVulnerablePopulationSelected = true. The protocol requires signed informed consent obtained prior to initiation of any study-specific procedures. Subjects are adult females (≥18); no procedures for assent or parental consent are described (minors are excluded). Subject information and informed consent forms are provided in the document list.

Inclusion criteria

  • {"criterion_text":"- 1.\t Signed informed consent obtained prior to initiation of any study-specific procedures.\n- 2.\t Female aged ≥18 years on day of signing informed consent.\n- 3.\tPatients with histologically diagnosed advanced (International Federation of Gynecology and Obstetrics [FIGO] stage III-IV) high grade serous or high grade endometrioid epithelial ovarian cancer (including primary peritoneal, or fallopian tube cancer).\n- 4.\tPatients with a complete or partial response to first line platinum-based treatment not including Bevacizumab.\n- 5.\tDocumented absence of somatic and germline mutations of BRCA 1 /2.\n- 6.\tPatients must have a life expectancy ≥ 16 weeks.\n- 7.\tEastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1.\n- 8.\tAvailability of sufficient formalin-fixed paraffin-embedded (FFPE) tumor tissue from the primary surgery (chemotherapy – naïve patients) for translational analysis. A quality control analysis of samples will be performed before patient’s enrollment.\n- 9.\t Patients must be enrolled within 8 weeks of the first day of the last dose of chemotherapy.\n- 10.\t Patients must be able to take oral medications.\n- 11.\tPostmenopausal or evidence of non-childbearing status for women of childbearing potential: negative urine or serum pregnancy test within 28 days of study treatment and confirmed prior to treatment on day 1. Postmenopausal is defined as: \tAmenorrheic for 1 year or more following cessation of exogenous hormonal treatments \tLuteinizing hormone (LH) and Follicle stimulating hormone (FSH) levels in the post-menopausal range for women under 50 \tradiation-induced oophorectomy with last menses >1 year ago \tchemotherapy-induced menopause with >1-year interval since last menses \tsurgical sterilisation (bilateral oophorectomy or hysterectomy)\n- 12.\tWomen of childbearing potential and their partners, who are sexually active, must agree to the use of one highly effective forms of contraception and their partners must use a male condom (as described in Appendix D). This should be started from the signing of the informed consent and continue throughout the period of taking study treatment and for at least 6 months after last dose of study drug\n- 13.\tPatients must have normal organ and bone marrow function measured within 28 days prior to administration of study treatment as defined below: \tHaemoglobin ≥ 10.0 g/dL with no blood transfusion in the past 28 days \tAbsolute neutrophil count (ANC) ≥ 1.5 x 109/L \tPlatelet count ≥ 100 x 109/L \tTotal bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) \tAspartate aminotransferase (AST) (Serum Glutamic Oxaloacetic Transaminase (SGOT)) / Alanine aminotransferase (ALT) (Serum Glutamic Pyruvate Transaminase (SGPT)) ≤ 2.5 x institutional upper limit of normal unless liver metastases are present in which case they must be ≤ 5x ULN \tPatients must have creatinine clearance estimated of ≥51 mL/min using the Cockcroft-Gault equation or based on a 24-hour urine test: o\tEstimated creatinine clearance = (140-age [years]) x weight (kg) (x F)a o\tserum creatinine (mg/dL) x 72 a where F=0.85 for females\n- 14.\tWillingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other trial procedures."}

Exclusion criteria

  • {"criterion_text":"- 1.\tPatients have received Bevacizumab in concomitance with first line platinum-based therapy or as maintenance therapy following chemotherapy.\n- 2.\tClear cell, mucinous and mixed Mullerian tumors/carcinosarcoma, non-epithelian tumors or ovarian tumors with low malignant potential (ie. borderline tumors) are not allowed.\n- 3.\tReceived chemotherapy within 14 days to first dose to study drug and/or persistent toxicities (>Common Terminology Criteria for Adverse Event (CTCAE) grade 2) caused by previous cancer therapy, excluding alopecia, peripheral neuropathy and related effects of prior chemotherapy that are unlikely to be exacerbated by treatment with study drugs.\n- 4.\tPrevious allogenic bone marrow transplant or double umbilical cord blood transplantation (dUCBT).\n- 5.\tWhole blood transfusions in the last 120 days prior to entry to the study (packed red blood cells and platelet transfusions are acceptable).\n- 6.\tBreast feeding women.\n- 7.\tPatients with myelodysplastic syndrome/acute myeloid leukaemia or with features suggestive of MDS/AML.\n- 8.\t Patients considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection that may interfere with planned treatment, affect patient compliance or place the patient at high risk from treatment related complications [Examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent (within 3 months) myocardial infarction, New York Heart Association (NYHA) grade II or greater congestive heart failure, uncontrolled hypertension, severe peripheral vascular disease, uncontrolled major seizure disorder, unstable spinal cord compression, superior vena cava syndrome, extensive interstitial bilateral lung disease on High Resolution Computed Tomography (HRCT) scan or any psychiatric illness ]\n- 9.\tPatients with active second malignancy.\n- 10.\tOther malignancy unless curatively treated with no evidence of disease for ≥5 years except: adequately treated non-melanoma skin cancer, curatively treated in situ cancer of the cervix, ductal carcinoma in situ (DCIS) and stage 1, grade 1 endometrial carcinoma.\n- 11.\tAny prior treatment for ovarian cancer, other than first line platinum-based therapy, including any maintenance treatment between completion of the platinum regimen and initiation of study drug in this study\n- 12.\tMajor surgery within 2 weeks of starting study treatment and patients must have recovered from any effects of any major surgery.\n- 13.\tConcurrent treatment with other investigational agents.\n- 14.\tPatients unable to swallow orally administered medication and patients with gastrointestinal disorders likely to interfere with absorption of the study medication.\n- 15.\tAny positive test result for hepatitis B virus or hepatitis C virus indicating presence of virus, eg. Hepatitis B surface antigen (HBsAg, Australia antigen) positive, or Hepatitis C antibody (anti-HCV) positive (except if HCV-RNA negative).\n- 16.\tImmunocompromised patients, e.g., patients who are known to be serologically positive for human immunodeficiency virus (HIV).\n- 17.\tPatients with symptomatic uncontrolled brain metastases. A TC/RMN scan of brain is required at baseline. The patient can receive a stable dose of corticosteroids before and during the study as long as these were started at least 4 weeks prior to treatment.\n- 18.\tPatients with spinal cord compression unless considered to have received definitive treatment for this and evidence of clinically stable disease for 28 days. For other exclusion criteria see protocol"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- PFS number of subjects who are progression- free from the beginning of the first line treatment","definition_or_measurement_approach":"Progression-free survival (PFS) measured as number of subjects who are progression-free from the beginning of the first-line treatment (as stated in endpoint description)."}

Secondary endpoints

  • {"endpoint_text":"- 1) PFS 2 Progression Free Survival 2\n- 2) OS Overall Survival\n- 3) toxicity profile (CTCAE 5.0 version) every 4 weeks (28gg)\n- 4) Define if there are prognostic factors between the biological and clinical characteristics of patients and tumor biomarkers, which can identify patients who have a better prognosis in terms of OS","definition_or_measurement_approach":"1) PFS2: progression-free survival after subsequent treatment (PFS2) as defined in protocol; 2) OS: overall survival; 3) toxicity profile assessed using CTCAE v5.0 every 4 weeks (28 days); 4) exploratory analyses to identify prognostic clinical and biological/tumour biomarker factors associated with OS."}

Recruitment

Planned Sample Size
200
Recruitment Window Months
57
Consent Approach
Signed informed consent obtained prior to initiation of any study-specific procedures. Participants are adult females (≥18) who provide consent themselves. Subject information and informed consent forms (multiple versions) are listed in the documents; no assent or parental consent procedures are described.

Geography

Total Number Of Sites
45
Total Number Of Participants
200

Italy

Earliest CTIS Part Ii Submission Date
11-11-2024
Latest Decision Or Authorization Date
20-04-2026
Processing Time Days
525
Number Of Sites
45
Number Of Participants
200

Sites

Site Name
Ospedale Misericordia - Grosseto - Azienda Usl Toscana sud est
Department Name
Unita Operativa Complessa Oncologia
Principal Investigator Name
Roberta Di Rocco
Principal Investigator Email
robertadirocco22@gmail.com
Contact Person Name
Roberta Di Rocco
Contact Person Email
robertadirocco22@gmail.com
Site Name
Azienda Socio-Sanitaria Territoriale della Valle Olona
Department Name
Oncologia Medica Presidio Ospedaliero di Saronno - ASST della Valle Olona
Principal Investigator Name
Giuseppe Di Lucca
Principal Investigator Email
giuseppe.dilucca@asst-valleolona.it
Contact Person Name
Giuseppe Di Lucca
Site Name
PO Garibaldi-Nesima, ARNAS Garibaldi
Department Name
U.O.C. Oncologia Medica
Principal Investigator Name
Roberto Bordonaro
Principal Investigator Email
rbordonaro63@gmail.com
Contact Person Name
Roberto Bordonaro
Contact Person Email
rbordonaro63@gmail.com
Site Name
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
Department Name
Oncologia Medica
Principal Investigator Name
Alberto Farolfi
Principal Investigator Email
alberto.farolfi@irst.emr.it
Contact Person Name
Alberto Farolfi
Contact Person Email
alberto.farolfi@irst.emr.it
Site Name
Azienda Ospedaliera Universitaria Integrata Verona
Department Name
UOC Oncologia
Principal Investigator Name
Veronica Parolin
Principal Investigator Email
veronica.parolin@aovr.veneto.it
Contact Person Name
Veronica Parolin
Site Name
Azienda Ospedaliero-Universitaria Maggiore Della Carita
Department Name
SCDU Oncologia
Principal Investigator Name
Alessandra Gennari
Principal Investigator Email
alessandra.gennari@uniupo.it
Contact Person Name
Alessandra Gennari
Contact Person Email
alessandra.gennari@uniupo.it
Site Name
Ospedale Casa sollievo della sofferenza
Department Name
Oncologia Medica
Principal Investigator Name
Franco Morelli
Principal Investigator Email
f.morelli@operapadrepio.it
Contact Person Name
Franco Morelli
Contact Person Email
f.morelli@operapadrepio.it
Site Name
Humanitas Mirasole S.p.A.
Department Name
UO Ginecologia Oncologica Medica - Casa di Cura San Pio X -Humanitas
Principal Investigator Name
Domenica Lorusso
Principal Investigator Email
domenica.lorusso@hunimed.eu
Contact Person Name
Domenica Lorusso
Contact Person Email
domenica.lorusso@hunimed.eu
Site Name
AORN San Giuseppe Moscati Avellino
Department Name
U.O. di Oncologia Medica
Principal Investigator Name
Emanuela Rossi
Principal Investigator Email
emanuelarossi41@libero.it
Contact Person Name
Emanuela Rossi
Contact Person Email
emanuelarossi41@libero.it
Site Name
Ospedale San Raffaele S.r.l.
Department Name
U.O. di Ginecologia e Ostetricia
Principal Investigator Name
Alice Bergamini
Principal Investigator Email
bergamini.alice@unisr.it
Contact Person Name
Alice Bergamini
Contact Person Email
bergamini.alice@unisr.it
Site Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Department Name
U.O. di Ginecologia Oncologica
Principal Investigator Name
Claudia Marchetti
Principal Investigator Email
claudia.marchetti@policlinicogemelli.it
Contact Person Name
Claudia Marchetti
Site Name
Ospedale Di Sassuolo S.p.A.
Department Name
Day Hospital Oncologico -Ospedale di Sassuolo
Principal Investigator Name
Lucia Longo
Principal Investigator Email
l.longo@ausl.mo.it
Contact Person Name
Lucia Longo
Contact Person Email
l.longo@ausl.mo.it
Site Name
Azienda Ospedaliera Universitaria Mater Domini
Department Name
UO Oncologia Medica Traslazionale - Presidio Mater Domini dell'AOURD “Renato Dulbecco (Catanzaro)
Principal Investigator Name
Pierosandro Tagliaferri
Principal Investigator Email
tagliaferri@unicz.it
Contact Person Name
Pierosandro Tagliaferri
Contact Person Email
tagliaferri@unicz.it
Site Name
Azienda Unita' Locale Socio Sanitaria N. 2 Marca Trevigiana
Department Name
Oncologia Medica Ospedale di Treviso
Principal Investigator Name
Grazia Artioli
Principal Investigator Email
grazia.artioli@yahoo.it
Contact Person Name
Grazia Artioli
Contact Person Email
grazia.artioli@yahoo.it
Site Name
Azienda Ospedaliera Universitaria Careggi
Department Name
Ginecologia e Ostetricia AZ.Careggi Firenze
Principal Investigator Name
Massimiliano Fambrini
Principal Investigator Email
massimiliano.fambrini@unifi.it
Contact Person Name
Massimiliano Fambrini
Contact Person Email
massimiliano.fambrini@unifi.it
Site Name
Azienda Unita Locale Socio Sanitaria N 8 Berica
Department Name
Ospedale San Bortolo UOC Oncologia
Principal Investigator Name
Lucia Borgato
Principal Investigator Email
lucia.borgato@aulss8.veneto.it
Contact Person Name
Lucia Borgato
Contact Person Email
lucia.borgato@aulss8.veneto.it
Site Name
Azienda Ulss 5 Polesana
Department Name
SOC Oncologia Azienda ULSS5 polesana Rovigo
Principal Investigator Name
Carmen Barile
Principal Investigator Email
carmen.barile@aulss5.veneto.it
Contact Person Name
Carmen Barile
Contact Person Email
carmen.barile@aulss5.veneto.it
Site Name
Azienda Ospedaliera Universitaria Federico II Di Napoli
Department Name
Oncologia Medica
Principal Investigator Name
Roberto Bianco
Principal Investigator Email
robianco@unina.it
Contact Person Name
Roberto Bianco
Contact Person Email
robianco@unina.it
Site Name
Centro Di Riferimento Oncologico Di Aviano
Department Name
SOC Oncologia Medica e Prevenzione Oncologica -Centro di Riferimento Oncologico, Aviano (PN)
Principal Investigator Name
Milena Nicoloso
Principal Investigator Email
mnicoloso@cro.it
Contact Person Name
Milena Nicoloso
Contact Person Email
mnicoloso@cro.it
Site Name
Ospedale S G Moscati
Department Name
Oncologia - Ospedale S. G. Moscati - Statte (TA)
Principal Investigator Name
Salvatore Pisconti
Principal Investigator Email
salvatore.pisconti@asl.taranto.it
Contact Person Name
Salvatore Pisconti
Site Name
Azienda Ospedaliera Per L'Emergenza Cannizzaro
Department Name
UOC di Oncologia Medica - AOE Cannizzaro (Catania)
Principal Investigator Name
Giuseppa Scandurra
Principal Investigator Email
giusy.scandurra@gmail.com
Contact Person Name
Giuseppa Scandurra
Contact Person Email
giusy.scandurra@gmail.com
Site Name
Azienda Unita Sanitaria Locale Di Modena
Department Name
UOC Medicina Oncologica - Ospedale Ramazzini di Carpi AUSL Modena + DH Ospedale di Mirandola
Principal Investigator Name
Donatella Giardina
Principal Investigator Email
d.giardina@ausl.mo.it
Contact Person Name
Donatella Giardina
Contact Person Email
d.giardina@ausl.mo.it
Site Name
Azienda Ospedaliero-Universitaria Sant'Anna
Department Name
U.O di Oncologia Clinica
Principal Investigator Name
Federica Lancia
Principal Investigator Email
federica.lancia@ospfe.it
Contact Person Name
Federica Lancia
Contact Person Email
federica.lancia@ospfe.it
Site Name
Ospedale Mater Salutis Di Legnago
Department Name
Oncologia Medica
Principal Investigator Name
Filippo Greco
Principal Investigator Email
filippo.greco@aulss9.veneto.it
Contact Person Name
Filippo Greco
Contact Person Email
filippo.greco@aulss9.veneto.it
Site Name
Ente Ecclesiastico Ospedale Generale Regionale Miulli
Department Name
UOSD Oncologia Ginecologica
Principal Investigator Name
Francesco Legge
Principal Investigator Email
f.legge@miulli.it
Contact Person Name
Francesco Legge
Contact Person Email
f.legge@miulli.it
Site Name
IRCCS Istituti Fisioterapici Ospitalieri- Istituto Nazionale tumori Regina Elena
Department Name
UOC Oncologia Medica 1
Principal Investigator Name
Antonella Savarese
Principal Investigator Email
antonella.savarese@ifo.gov.it
Contact Person Name
Antonella Savarese
Contact Person Email
antonella.savarese@ifo.gov.it
Site Name
IRCCS Ospedale Policlinico San Martino
Department Name
Oncologia Medica 1
Principal Investigator Name
Valeria Andretta
Principal Investigator Email
valeria.andretta@hsanmartino.it
Contact Person Name
Valeria Andretta
Site Name
IRCCS Istituto Nazionale Tumori Fondazione Pascale
Department Name
Dip. Uro-Ginecologico, S.C. Oncologia Clinica Sperimentale Uro-Ginecologica
Principal Investigator Name
Sandro Pignata
Principal Investigator Email
s.pignata@istitutotumori.na.it
Contact Person Name
Sandro Pignata
Contact Person Email
s.pignata@istitutotumori.na.it
Site Name
Azienda Sanitaria Locale Al Di Alessandria
Department Name
Oncologia Ospedale S.Spirito- Casale Monferrato
Principal Investigator Name
Roberta Buosi
Principal Investigator Email
rbuosi@aslal.it
Contact Person Name
Roberta Buosi
Contact Person Email
rbuosi@aslal.it
Site Name
Azienda Unita Sanitaria Locale Della Romagna
Department Name
Oncologia -Ospedale Umberto I - Lugo (RA)
Principal Investigator Name
Claudia Casanova
Principal Investigator Email
casanova.claudia@libero.it
Contact Person Name
Claudia Casanova
Contact Person Email
casanova.claudia@libero.it
Site Name
A. O. U. Policlinico Sant'Orsola Malpighi
Department Name
SSD Oncologia Medica Addarii
Principal Investigator Name
Claudio Zamagni
Principal Investigator Email
claudio.zamagni@aosp.bo.it
Contact Person Name
Claudio Zamagni
Contact Person Email
claudio.zamagni@aosp.bo.it
Site Name
Istituto Di Candiolo Fondazione Del Piemonte Per L'Oncologia IRCCS
Department Name
Oncologia Medica
Principal Investigator Name
Luigi Carlo Turco
Principal Investigator Email
luigicarlo.turco@ircc.it
Contact Person Name
Luigi Carlo Turco
Contact Person Email
luigicarlo.turco@ircc.it
Site Name
Azienda Unita Sanitaria Locale Della Romagna
Department Name
Oncologia Medica -Osp. S. Maria delle Croci - AUSL di Ravenna
Principal Investigator Name
Claudia Casanova
Principal Investigator Email
casanova.claudia@libero.it
Contact Person Name
Claudia Casanova
Contact Person Email
casanova.claudia@libero.it
Site Name
Azienda Unita Sanitaria Locale Della Romagna
Department Name
U.O. di Oncologia Medica -Ospedale Civile degli Infermi Faenza
Principal Investigator Name
Claudia Casanova
Principal Investigator Email
casanova.claudia@libero.it
Contact Person Name
Claudia Casanova
Contact Person Email
casanova.claudia@libero.it
Site Name
Ospedale Santa Maria della Misericordia
Department Name
Dipartimento di Oncologia -A.O.U. S. Maria della Misericordia -Udine
Principal Investigator Name
Claudia Andreetta
Principal Investigator Email
claudia.andreetta@asufc.sanita.fvg.it
Contact Person Name
Claudia Andreetta
Site Name
ASST Grande Ospedale Metropolitano Niguarda
Department Name
Oncologia Medica Falck, Ospedale Niguarda Ca' Granda
Principal Investigator Name
Ilaria Schiavetto
Principal Investigator Email
ilaria.schiavetto@ospedaleniguarda.it
Contact Person Name
Ilaria Schiavetto
Site Name
Ospedale Santa Maria Della Misericordia - Azienda Ospedaliera di Perugia
Department Name
S.C. di Oncologia Medica Osp. S. Maria della Misericordia
Principal Investigator Name
Anna Maria Mosconi
Principal Investigator Email
annamaria.mosconi@alice.it
Contact Person Name
Anna Maria Mosconi
Contact Person Email
annamaria.mosconi@alice.it
Site Name
Azienda Sanitaria Universitaria Giuliano Isontina
Department Name
Centro Sociale Oncologico SSD-OSARF
Principal Investigator Name
Angela Denaro
Principal Investigator Email
angela.denaro@asugi.sanita.fvg.it
Contact Person Name
Angela Denaro
Site Name
Ospedale "A. Perrino"
Department Name
U.O.C. Oncologia Medica
Principal Investigator Name
Saverio Cinieri
Principal Investigator Email
saverio.cinieri@asl.brindisi.it
Contact Person Name
Saverio Cinieri
Site Name
Azienda Ospedaliero Universitaria Parma
Department Name
Oncologia
Principal Investigator Name
Angelica Sikokis
Principal Investigator Email
asikokis@ao.pr.it
Contact Person Name
Angelica Sikokis
Contact Person Email
asikokis@ao.pr.it
Site Name
Azienda Ospedaliera Ordine Mauriziano Di Torino
Department Name
Dipartimento di Oncologia
Principal Investigator Name
Giorgio Valabrega
Principal Investigator Email
giorgio.valabrega@unito.it
Contact Person Name
Giorgio Valabrega
Contact Person Email
giorgio.valabrega@unito.it
Site Name
Azienda USL IRCCS Di Reggio Emilia
Department Name
Oncologia Medica, A.U.S.L. di Reggio Emilia - IRCCS - Presidio Arcispedale S. Maria Nuova
Principal Investigator Name
Alessandra Bologna
Principal Investigator Email
Alessandra.Bologna@ausl.re.it
Contact Person Name
Alessandra Bologna
Contact Person Email
Alessandra.Bologna@ausl.re.it
Site Name
ASST Rhodense/Presidio Ospedaliero di Rho
Department Name
Oncologia Medica -ASST Rhodense - Presidio di Rho - MI
Principal Investigator Name
Roberto Bollina
Principal Investigator Email
rbollina@asst-rhodense.it
Contact Person Name
Roberto Bollina
Contact Person Email
rbollina@asst-rhodense.it
Site Name
Azienda Ospedaliera Santa Croce E Carle
Department Name
Ostetricia e Ginecologia
Principal Investigator Name
Marcella Occelli
Principal Investigator Email
occelli.m@ospedale.cuneo.it
Contact Person Name
Marcella Occelli
Contact Person Email
occelli.m@ospedale.cuneo.it
Site Name
Pia Fondazione Di Culto E Religione Card G Panico
Department Name
Oncologia
Principal Investigator Name
Maria Teresa Elia
Principal Investigator Email
mtelia@libero.it
Contact Person Name
Maria Teresa Elia
Contact Person Email
mtelia@libero.it

Sponsor

Primary sponsor

Full Name
IRCCS Istituto Nazionale Tumori Fondazione Pascale
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
Italy

Third parties

  • {"country":"","full_name":"AstraZeneca S.p.A.","duties_or_roles":"Source of monetary support","organisation_type":""}

Investigational products

Investigational Product Name
Lynparza 100 mg film-coated tablets
Active Substance
OLAPARIB
Modality
Small molecule
Routes Of Administration
Oral
Route
Oral
Authorisation Status
Marketing authorisation: EU/1/14/959/003
Dose Levels
100 mg
Maximum Dose
600 mg
Investigational Product Name
Lynparza 150 mg film-coated tablets
Active Substance
OLAPARIB
Modality
Small molecule
Routes Of Administration
Oral
Route
Oral
Authorisation Status
Marketing authorisation: EU/1/14/959/004
Dose Levels
150 mg
Maximum Dose
600 mg

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