Clinical trial • Phase III • Oncology

OLAPARIB for BRCA-mutated ovarian cancer | Epithelial ovarian cancer | Platinum-sensitive relapsed ovarian cancer | Metastatic breast cancer | Metastatic pancreatic cancer | Prostate cancer | Endometrial cancer

Phase III trial of OLAPARIB for BRCA-mutated ovarian cancer | Epithelial ovarian cancer | Platinum-sensitive relapsed ovarian cancer | Metastatic breast c…

Overview

Trial Therapeutic Area
Oncology
Trial Disease
BRCA-mutated ovarian cancer | Epithelial ovarian cancer | Platinum-sensitive relapsed ovarian cancer | Metastatic breast cancer | Metastatic pancreatic cancer | Prostate cancer | Endometrial cancer
Trial Stage
Phase III
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
16-07-2024
First CTIS Authorization Date
13-08-2024

Trial design

open-label, none/not specified-controlled Phase III trial across 53 sites in Belgium, France, Germany and others.

Open Label
Yes
Comparator
None/Not specified
Target Sample Size
94

Eligibility

Recruits 94 Vulnerable population selected. Informed consent required: '1 Provision of signed and dated, written ICF.' No details on assent or parental consent processes for minors (if any) are provided in the available record..

Vulnerable Population
Vulnerable population selected. Informed consent required: '1 Provision of signed and dated, written ICF.' No details on assent or parental consent processes for minors (if any) are provided in the available record.

Inclusion criteria

  • {"criterion_text":"- 1 Provision of signed and dated, written ICF.\n- 2 Patient is currently deriving clinical benefit, as judged by the Investigator, from continued treatment in an AZ parent study using an AstraZeneca (AZ) compound that has met its endpoints or has otherwise stopped.\n- 3 Patient participating in a prior oncology study with an AZ compound in which they received olaparib and are continuing to receive clinical benefit from treatment; the prior study can be an open-label or blinded study, with unblinding at study close."}

Exclusion criteria

  • {"criterion_text":"- 1 Ongoing, unresolved, Grade 3 or above toxicity requiring interruption of treatment at the time of the termination of the parent study.\n- 2 Currently receiving treatment with any prohibited medication(s).\n- 3 Concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.\n- 4 Permanent discontinuation from the parent study due to toxicity or disease progression (increase in the severity of the disease under study and/or increases in the symptoms of a patient's condition attributable to the disease, as assessed and documented by the Investigator. Physician-defined progression can be radiological [eg, RECIST] progression or clinical progression).\n- 5 Local access to commercially-available drug at no cost to the patient, as permitted by local/country regulation."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- SAEs and AESIs reported until 30 days after the last dose of study drug.","definition_or_measurement_approach":"Serious adverse events (SAEs) and adverse events of special interest (AESIs) reported and collected through standard safety reporting processes up to 30 days after the participant's last dose of study drug."}

Recruitment

Planned Sample Size
94
Recruitment Window Months
123
Consent Approach
Provision of a signed and dated written informed consent form (ICF) is required. Country-specific ICF documents are available (multiple language versions and country variants are listed in the application: e.g., English, Dutch, French, German, Hungarian, Swedish, Polish, Italian, Portuguese, Bulgarian, Czech). Consent is provided by the participant (adult); no specific assent/parental consent procedures for minors are described in the available record.

Methods

  • Recruitment from patients who have completed a parent AstraZeneca oncology study and are judged by the Investigator to continue deriving clinical benefit from olaparib (i.e., roll-over from parent AZ trials).
  • Recruitment conducted via participating hospital/oncology clinical sites across the authorised EU Member States listed in the application (country-specific site lists are provided in the application).

Geography

Total Number Of Sites
53
Total Number Of Participants
94

Belgium

Earliest CTIS Part Ii Submission Date
07-08-2024
Latest Decision Or Authorization Date
14-08-2024
Processing Time Days
7
Number Of Sites
2
Number Of Participants
2

Sites

Site Name
UZ Leuven
Department Name
0501: Gynaecologische Oncologie
Contact Person Name
Els Van Nieuwenhuysen
Site Name
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur
Department Name
0502: Oncology
Contact Person Name
Stéphanie Henry
Contact Person Email
stephanie.henry@uclouvain.be

France

Earliest CTIS Part Ii Submission Date
03-09-2024
Latest Decision Or Authorization Date
05-09-2024
Processing Time Days
2
Number Of Sites
4
Number Of Participants
4

Sites

Site Name
Centre Leon Berard
Department Name
2310: Département d'Oncologie Médicale
Contact Person Name
Isabelle-Laure Ray-Coquard
Site Name
Hopital Paul Brousse
Department Name
2313: Oncology
Contact Person Name
Pascal Hammel
Contact Person Email
pascal.hammel@aphp.fr
Site Name
Centre Oscar Lambret
Department Name
2314: Centre Oscar Lambret
Contact Person Name
Aurélien Carnot
Contact Person Email
a-carnot@o-lambret.fr
Site Name
Hopital Prive Des Cotes D'armor
Department Name
2307: Service Oncologie
Contact Person Name
Jérôme Martin-Babau
Contact Person Email
j.martin@cario-sante.fr

Germany

Earliest CTIS Part Ii Submission Date
07-08-2024
Latest Decision Or Authorization Date
19-08-2024
Processing Time Days
12
Number Of Sites
1
Number Of Participants
1

Sites

Site Name
Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR
Department Name
2601: Frauenheilkunde, Geburtshilfe
Contact Person Name
Pauline Wimberger
Contact Person Email
pauline.wimberger@ukdd.de

Hungary

Earliest CTIS Part Ii Submission Date
07-08-2024
Latest Decision Or Authorization Date
14-08-2024
Processing Time Days
7
Number Of Sites
2
Number Of Participants
2

Sites

Site Name
Orszagos Onkologiai Intezet
Department Name
3301:Nőgyógyászati Onkológia
Contact Person Name
Imre Pete
Contact Person Email
pete@oncol.hu
Site Name
Szent Margit Korhaz
Department Name
3302:Onkológia
Contact Person Name
Boer Katalin
Contact Person Email
katalin.boer@t-online.hu

Slovenia

Earliest CTIS Part Ii Submission Date
07-08-2024
Latest Decision Or Authorization Date
21-08-2024
Processing Time Days
14
Number Of Sites
1
Number Of Participants
2

Sites

Site Name
Institute Of Oncology Ljubljana
Department Name
6801: Oncology
Contact Person Name
Erik Skof
Contact Person Email
eskof@onko-i.si

Spain

Earliest CTIS Part Ii Submission Date
07-08-2024
Latest Decision Or Authorization Date
13-08-2024
Processing Time Days
6
Number Of Sites
11
Number Of Participants
25

Sites

Site Name
Hospital Universitario Y Politecnico La Fe
Department Name
7001: Oncología
Contact Person Name
Ana Santaballa Bertrán
Contact Person Email
anasantaballa@gmail.com
Site Name
Hospital Universitario Virgen De Las Nieves
Department Name
7012: Oncología Medica
Contact Person Name
Encarnación González Flores
Site Name
Complexo Hospitalario Universitario De Vigo
Department Name
7009: Oncología Médica
Contact Person Name
Isabel Lorenzo Lorenzo
Site Name
Hospital Universitari Vall D Hebron
Department Name
7010: Oncología Médica
Contact Person Name
Judith Balmaña Gelpi
Contact Person Email
jbalmana@vhio.net
Site Name
Hospital Universitario Donostia
Department Name
7021: Oncologia
Contact Person Name
Isabel Álvarez López
Site Name
Institut Catala D'oncologia (Badalona)
Department Name
7007: Oncología
Contact Person Name
Margarita Romeo Marín
Contact Person Email
mromeo@iconcologia.net
Site Name
Hospital Universitario Miguel Servet
Department Name
7003: Oncología
Contact Person Name
Ana Herrero Ibañez
Contact Person Email
herreroa@yahoo.es
Site Name
Clinica Universidad De Navarra (Pamplona)
Department Name
7011: Oncología Medica
Contact Person Name
Marta Santisteban Eslava
Contact Person Email
msantisteb@unav.es
Site Name
Clinica Universidad De Navarra (Madrid)
Department Name
7017: Oncología
Contact Person Name
Marta Santisteban Eslava
Contact Person Email
msantisteb@unav.es
Site Name
Hospital Universitario Reina Sofia
Department Name
7020: Oncología Medica
Contact Person Name
Maria Jesús Rubio
Contact Person Email
mjesusrubio63@gmail.com
Site Name
Institut Catala D'oncologia (L'hospitalet)
Department Name
7006: Oncologia
Contact Person Name
Beatriz Pardo Búrdalo
Contact Person Email
bpardo@iconcologia.net

Sweden

Earliest CTIS Part Ii Submission Date
07-08-2024
Latest Decision Or Authorization Date
14-08-2024
Processing Time Days
7
Number Of Sites
1
Number Of Participants
3

Sites

Site Name
Skanes University Hospital
Department Name
7201:Hematology, Oncology and Radiation Physics
Contact Person Name
Maria Bjurberg
Contact Person Email
Maria.Bjurberg@skane.se

Poland

Earliest CTIS Part Ii Submission Date
07-08-2024
Latest Decision Or Authorization Date
24-09-2024
Processing Time Days
48
Number Of Sites
6
Number Of Participants
13

Sites

Site Name
Wielkopolskie Centrum Onkologii Im. Marii Sklodowskiej-Curie
Department Name
5708:Oddzial Radioterapii i Onkologii Ginekologicznej
Contact Person Name
Krystyna Bratos
Contact Person Email
krystyna.bratos@wco.pl
Site Name
Centrum Onkologii Ziemi Lubelskiej Im. Sw. Jana Z Dukli
Department Name
5707:I Oddzial Ginekologii Onkologicznej COZL
Contact Person Name
Dariusz Kieszko
Contact Person Email
dkieszko@cozl.eu
Site Name
Bialostockie Centrum Onkologii Im. Marii Sklodowskiej-Curie W Bialymstoku
Department Name
5702:Oddzial Onkologii Ginekologicznej
Contact Person Name
Beata Mackowiak - Matejczyk
Site Name
Uniwersytecki Szpital Kliniczny W Poznaniu
Department Name
5701:Oddzial Ginekologii Onkologicznej
Contact Person Name
Radoslaw Madry
Contact Person Email
r.madry.mac@gmail.com
Site Name
NZOZ Innowacyjna Medycyna Read-Gene S.A.
Department Name
5705
Contact Person Name
Tomasz Huzarski
Contact Person Email
huzarscy@onet.eu
Site Name
Wojewodzki Szpital Specjalistyczny W Olsztynie
Department Name
5706:Oddzial Ginekologii Onkologicznej
Contact Person Name
Magdalena Sikorska
Contact Person Email
megiann@wp.pl

Portugal

Earliest CTIS Part Ii Submission Date
07-08-2024
Latest Decision Or Authorization Date
25-09-2024
Processing Time Days
49
Number Of Sites
2
Number Of Participants
2

Sites

Site Name
Unidade Local De Saude De Santa Maria E.P.E.
Department Name
5802: Oncologia
Contact Person Name
Luis Marques da Costa
Contact Person Email
luis.costa@chln.min-saude.pt
Site Name
Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E.
Department Name
5801:Anesthesiology/Reanimation
Contact Person Name
Marta Ferreira

Bulgaria

Earliest CTIS Part Ii Submission Date
07-08-2024
Latest Decision Or Authorization Date
15-08-2024
Processing Time Days
8
Number Of Sites
3
Number Of Participants
7

Sites

Site Name
Muliprofile Hospital For Active Treatment Central Onco Hospital OOD
Department Name
0901: Oncology Department
Contact Person Name
Rumyana Ilieva
Contact Person Email
md_rumi@abv.bg
Site Name
Complex Oncological Center Plovdiv EOOD
Department Name
0907
Contact Person Name
Antoaneta Tomova
Contact Person Email
dr.tomova@gmail.com
Site Name
Medical Centre Nadezhda Clinical EOOD
Department Name
0902
Contact Person Name
Georgi Zhbantov
Contact Person Email
jbantov_medicina67@abv.bg

Czechia

Earliest CTIS Part Ii Submission Date
07-08-2024
Latest Decision Or Authorization Date
14-08-2024
Processing Time Days
7
Number Of Sites
6
Number Of Participants
14

Sites

Site Name
Masarykuv Onkologicky Ustav
Department Name
1905: Odd. gynekologicke onkologie
Contact Person Name
Maria Zvarikova
Contact Person Email
zvarikova@mou.cz
Site Name
Vseobecna Fakultni Nemocnice V Praze
Department Name
1901: Gynekolog-porodnicka klinika
Contact Person Name
David Cibula
Contact Person Email
dc@davidcibula.cz
Site Name
Fakultni Nemocnice Ostrava
Department Name
1902: Onkologicka klinika
Contact Person Name
Jan Kummel
Contact Person Email
jan.kummel@fno.cz
Site Name
Fakultni Nemocnice V Motole
Department Name
1904: Onkologicka klinika
Contact Person Name
Zdenek Linke
Contact Person Email
zdenek.linke@fnmotol.cz
Site Name
Fakultni Nemocnice Brno
Department Name
1907: Gynekologicko-porodnicka klinika
Contact Person Name
Vit Weinberger
Contact Person Email
weinberger.vit@fnbrno.cz
Site Name
University Hospital Olomouc
Department Name
1906: Onkologicka klinika
Contact Person Name
Bohuslav Melichar
Contact Person Email
bohuslav.melichar@fnol.cz

Italy

Earliest CTIS Part Ii Submission Date
07-08-2024
Latest Decision Or Authorization Date
02-09-2024
Processing Time Days
26
Number Of Sites
14
Number Of Participants
19

Sites

Site Name
Istituto Di Candiolo Fondazione Del Piemonte Per L'Oncologia IRCCS
Department Name
4104:Day Hospital Oncologico
Contact Person Name
Vanesa Gregorc
Contact Person Email
vanesa.gregorc@ircc.it
Site Name
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
Department Name
4106:Divisione di Ostetricia e Ginecologia
Contact Person Name
Germana Tognon
Contact Person Email
germanatognon@gmail.com
Site Name
Universita Cattolica Del Sacro Cuore
Department Name
4105:Ginecologia oncologica
Contact Person Name
Vanda Salutari
Site Name
IRCCS Istituto Nazionale Tumori Fondazione Pascale
Department Name
4101:Dipartimento Uro-Ginecologico
Contact Person Name
Sandro Pignata
Contact Person Email
s.pignata@istitutotumori.na.it
Site Name
Ospedale Vito Fazzi Lecce
Department Name
4111:U.O.C. di Oncologia Medica
Contact Person Name
Graziana Ronzino
Contact Person Email
dspolecce@asl.lecce.it
Site Name
Azienda Ospedaliera Universitaria Integrata Verona
Department Name
4117:Oncologia
Contact Person Name
Michele Milella
Contact Person Email
michele.milella@aovr.veneto.it
Site Name
Azienda Ospedaliero Universitaria Delle Marche
Department Name
4112:Clinica Oncologica
Contact Person Name
Rossana Berardi
Site Name
Azienda Ospedaliera Per L'Emergenza Cannizzaro
Department Name
4110:Ginecologia oncologica
Contact Person Name
Paolo Scollo
Contact Person Email
paolo.6giugno@gmail.com
Site Name
Istituto Europeo Di Oncologia S.r.l.
Department Name
4113:Unità di Ginecologia OncologicUnità Operativa di Ginecologia e Ostetricia I
Contact Person Name
Nicoletta Colombo
Contact Person Email
nicoletta.colombo@ieo.it
Site Name
Ospedale San Raffaele S.r.l.
Department Name
4109:Unità Operativa di Ginecologia e Ostetricia I
Contact Person Name
Giorgia Mangili
Contact Person Email
mangili.giorgia@hsr.it
Site Name
Alessandro Manzoni Hospital
Department Name
4118:Oncologia
Contact Person Name
Antonio Ardizzoia
Contact Person Email
a.ardizzoia@asst-lecco.it
Site Name
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
Department Name
4108:SSD Oncol.Med. Addarii-Zamagni
Contact Person Name
Claudio Zamagni
Contact Person Email
claudio.zamagni@aosp.bo.it
Site Name
Azienda Ospedaliera Ordine Mauriziano Di Torino
Department Name
4114:Unità di Oncologia Ginecologica
Contact Person Name
Annamaria Ferrero
Contact Person Email
a.ferrero0505@gmail.com
Site Name
Istituto Oncologico Veneto
Department Name
4103:Oncologia Medica 2
Contact Person Name
Valentina Guarneri
Contact Person Email
valentina.guarneri@unipd.it

Sponsor

Primary sponsor

Full Name
AstraZeneca AB
Organisation Type
Pharmaceutical company
Country Of Registered Address
Sweden

Contract research organisations

Name
Parexel International (IRL) Limited
Responsibilities
Project leadership, site contracting; contact: Clinicaltrial.Enquiries@parexel.com; phone: 0035314739500

Third parties

  • {"country":"Ireland","full_name":"Parexel International (IRL) Limited","duties_or_roles":"Sponsor duties codes: 1,10,11,12,6; Project leadership, site contracting","organisation_type":"Pharmaceutical company"}

Investigational products

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 in EU (EU/1/14/959/004); product status indicated in application
Starting Dose
300 mg twice daily
Dose Levels
300 mg twice daily (continuous); dose reduction scheme permitted
Frequency
Twice daily
Maximum Dose
600 mg per day
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 in EU (EU/1/14/959/003); product status indicated in application
Starting Dose
300 mg twice daily (administered using available tablet strengths as per dosing instructions)
Dose Levels
300 mg twice daily (continuous); dose reduction scheme permitted
Frequency
Twice daily
Maximum Dose
600 mg per day

Related trials

Other published trials that may interest you.