Roll Over Study for Patients Who Have Completed a Previous Oncology Study with Olaparib

2024-512982-15-00 Protocol D0817C00098 Therapeutic confirmatory (Phase III) Ongoing, recruiting

Start 28 Jun 2021 · Status Ongoing, recruiting · 12 EU/EEA countries · 53 sites · Protocol D0817C00098

Overview

Sponsor-declared trial summary

Phase Therapeutic confirmatory (Phase III)
Status Ongoing, recruiting
Participants planned 188
Countries 12
Sites 53

BRCA Mutated Ovarian Cancer Patients, Epithelian ovarian cancer, Metastatic Breast Cancer, Platinum Sensitive Relapsed Ovarian Cancer, Patients with gBRCA mutated metastatic pancreatic cancer, prostate cancer, endometrium cancer

To provide continuous study treatment to patients who continue to benefit at the end of a clinical trial, while monitoring safety and tolerability

Key facts

Sponsor
AstraZeneca AB
Participant type
Patients
Age range
18-64 years, 65+ years
Gender
Male and Female
Therapeutic area
Diseases [C] - Neoplasms [C04]
Trial duration
28 Jun 2021 → ongoing
Decision date (initial)
2024-08-14
Transition trial
Yes
Low-intervention
No
Rare-disease indication
No
Vulnerable population
Yes
Funding sources
AstraZeneca AB

External identifiers

EU CT number
2024-512982-15-00
EudraCT number
2019-003777-26

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy

To provide continuous study treatment to patients who continue to benefit at the end of a clinical trial, while monitoring safety and tolerability

Conditions and MedDRA coding

BRCA Mutated Ovarian Cancer Patients, Epithelian ovarian cancer, Metastatic Breast Cancer, Platinum Sensitive Relapsed Ovarian Cancer, Patients with gBRCA mutated metastatic pancreatic cancer, prostate cancer, endometrium cancer

VersionLevelCodeTermSystem organ class
20.0 PT 10016180 Fallopian tube cancer 100000004864
21.0 PT 10014733 Endometrial cancer 100000004864
20.0 PT 10033128 Ovarian cancer 100000004864
27.0 LLT 10033605 Pancreatic cancer metastatic 10029104
20.0 PT 10006187 Breast cancer 100000004864
20.0 PT 10060862 Prostate cancer 100000004864

Study design 2 periods

#TitleAllocationBlindingRoles blindedArms
1 Treatment period
Olaparib tablets (300 mg twice daily, continuously, or per dose reduction scheme) should be taken at the same time each day, approximately 12 hours apart, with 1 glass of water. The tablets should be swallowed whole and not chewed, crushed, dissolved, or divided. Olaparib can be taken with or without food. There is no maximum duration for taking olaparib. Patients should continue to receive olaparib until they meet any of the study discontinuation criterion.
 2 None Treatment arm: Olaparib tablets (300 mg twice daily, continuously, or per dose reduction scheme) should be taken at the same time each day, approximately 12 hours apart, with 1 glass of water.
2 Follow-up period
A safety follow-up visit will be conducted approximately 30 days after last dose of study drug
 2 None

Regulatory references

Plan to share IPD
Yes
IPD plan description
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
EU CT numberTitleSponsor
2023-507337-22-00 Roll Over Study for Patients Who Have Completed a Previous Oncology Study with Durvalumab and Are Judged by the Investigator to Clinically Benefit From Continued Treatment Astrazeneca AB
2022-501528-58-00 ROSY-T: Roll Over StudY for Patients Who Have Completed a Previous Oncology Study with Osimertinib (TAGRISSO) and are Judged by the Investigator to Clinically Benefit From Continued Treatment Astrazeneca AB

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

  1. 1 Provision of signed and dated, written ICF.
  2. 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.
  3. 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 5

  1. 1 Ongoing, unresolved, Grade 3 or above toxicity requiring interruption of treatment at the time of the termination of the parent study.
  2. 2 Currently receiving treatment with any prohibited medication(s).
  3. 3 Concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.
  4. 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).
  5. 5 Local access to commercially-available drug at no cost to the patient, as permitted by local/country regulation.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

  1. SAEs and AESIs reported until 30 days after the last dose of study drug.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Lynparza 100 mg film-coated tablets

PRD6163466 · Product

Active substance
Olaparib
Pharmaceutical form
FILM-COATED TABLET
Route of administration
ORAL
Max daily dose
600 mg milligram(s)
Max total dose
600 mg milligram(s)
Max treatment duration
123 Month(s)
Authorisation status
Authorised
ATC code
L01XX46 — -
Marketing authorisation
EU/1/14/959/003
MA holder
ASTRAZENECA AB
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
Yes
Modification description
Lynparza Tablet is identical to the IMP except that it has a commercial deboss/marking. The IMP is unmarked and provided in an HDPE bottle rather than the commercial blister pack to facilitate blinding in placebo-controlled studies

Lynparza 150 mg film-coated tablets

PRD6152224 · Product

Active substance
Olaparib
Pharmaceutical form
FILM-COATED TABLET
Route of administration
ORAL
Max daily dose
600 mg milligram(s)
Max total dose
600 mg milligram(s)
Max treatment duration
123 Month(s)
Authorisation status
Authorised
ATC code
L01XX46 — -
Marketing authorisation
EU/1/14/959/004
MA holder
ASTRAZENECA AB
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
Yes
Modification description
Lynparza Tablet is identical to the IMP except that it has a commercial deboss/marking. The IMP is unmarked and provided in an HDPE bottle rather than the commercial blister pack to facilitate blinding in placebo-controlled studies

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

AstraZeneca AB

274 Total trials 84 Recruiting 173 Ended
Commercial
Sponsor organisation
AstraZeneca AB
Address
-
City
Sodertalje
Postcode
151 85
Country
Sweden

Scientific contact point

Organisation
AstraZeneca AB
Contact name
Clinical Study Information Center

Public contact point

Organisation
AstraZeneca AB
Contact name
Clinical Study Information Center

Third parties 1

OrganisationCity, countryDuties
Parexel International (IRL) Limited
ORG-100022780
 Dublin 2, Ireland On site monitoring, Code 10, Code 11, Code 12, Other, Data management

Locations

12 EU/EEA countries · 53 investigational sites

By country

CountryMS statusPlanned subjectsSites
Belgium Ongoing, recruiting 2 2
Bulgaria Ongoing, recruiting 7 3
Czechia Ongoing, recruiting 14 6
France Ongoing, recruiting 4 4
Germany Ongoing, recruiting 1 1
Hungary Ongoing, recruiting 2 2
Italy Ongoing, recruiting 19 14
Poland Ongoing, recruiting 13 6
Portugal Ongoing, recruiting 2 2
Slovenia Ongoing, recruiting 2 1
Spain Ongoing, recruiting 25 11
Sweden Ongoing, recruiting 3 1
Rest of world
United States, Taiwan, Turkey, Korea, Republic of, Israel, China, Brazil, United Kingdom, Russian Federation, Canada
 — 94 —

Investigational sites

Belgium

2 sites · Ongoing, recruiting
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur
0502: Oncology, Place Louise Godin 15, 5000, Namur
UZ Leuven
0501: Gynaecologische Oncologie, Herestraat 49, 3000, Leuven

Bulgaria

3 sites · Ongoing, recruiting
Muliprofile Hospital For Active Treatment Central Onco Hospital OOD
0901: Oncology Department, Bulevard Vasil Aprilov 20, 4002, Plovdiv
Complex Oncological Center Plovdiv EOOD
0907, Bulevard Aleksandir Stamboliyski 2a, 4004, Plovdiv
Medical Centre Nadezhda Clinical EOOD
0902, Blaga Vest Str 3, 1303, Sofia

Czechia

6 sites · Ongoing, recruiting
University Hospital Olomouc
1906: Onkologicka klinika, Zdravotniku 248/7, 779 00, Olomouc
Masarykuv Onkologicky Ustav
1905: Odd. gynekologicke onkologie, Zluty Kopec 543/7, Stare Brno, Brno-Stred
Fakultni Nemocnice V Motole
1904: Onkologicka klinika, V Uvalu 84/1, Motol, Prague
Fakultni Nemocnice Brno
1907: Gynekologicko-porodnicka klinika, Obilni Trh 526/11, Veveri, Brno-Stred
Vseobecna Fakultni Nemocnice V Praze
1901: Gynekolog-porodnicka klinika, Apolinarska 441/18 Nove Mesto, 128 00, Prague
Fakultni Nemocnice Ostrava
1902: Onkologicka klinika, 17. Listopadu 1790/5, Poruba, Ostrava

France

4 sites · Ongoing, recruiting
Centre Oscar Lambret
2314: Centre Oscar Lambret, 3 Rue Frederic Combemale, 59000, Lille
Hopital Paul Brousse
2313: Oncology, 12 Avenue Paul Vaillant Couturier, 94804, Villejuif Cedex
Hopital Prive Des Cotes D'armor
2307: Service Oncologie, 10 Rue Francois Jacob, 22190, Plerin
Centre Leon Berard
2310: Département d'Oncologie Médicale, 28 Rue Laennec, 69008, Lyon

Germany

1 site · Ongoing, recruiting
Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR
2601: Frauenheilkunde, Geburtshilfe, Fetscherstrasse 74, Johannstadt-Nord, Dresden

Hungary

2 sites · Ongoing, recruiting
Orszagos Onkologiai Intezet
3301:Nőgyógyászati Onkológia, Rath Gyorgy Utca 7-9, Kerulet, Budapest XII
Szent Margit Korhaz
3302:Onkológia, Becsi Ut 132, 1032, Budapest III

Italy

14 sites · Ongoing, recruiting
Azienda Ospedaliera Ordine Mauriziano Di Torino
4114:Unità di Oncologia Ginecologica, Via Ferdinando Magellano 1, 10128, Turin
IRCCS Istituto Nazionale Tumori Fondazione Pascale
4101:Dipartimento Uro-Ginecologico, Via Mariano Semmola 52, 80131, Naples
Alessandro Manzoni Hospital
4118:Oncologia, Via Dell' Eremo 9, 23900, Lecco
Azienda Ospedaliera Universitaria Integrata Verona
4117:Oncologia, Piazzale Ludovico Antonio Scuro 10, 37134, Verona
Istituto Oncologico Veneto
4103:Oncologia Medica 2, Via Gattamelata 64, 35128, Padova
Ospedale Vito Fazzi Lecce
4111:U.O.C. di Oncologia Medica, Piazza Filippo Muratore 1, 73100, Lecce
Ospedale San Raffaele S.r.l.
4109:Unità Operativa di Ginecologia e Ostetricia I, Via Olgettina 60, 20132, Milan
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
4106:Divisione di Ostetricia e Ginecologia, Piazzale Spedali Civili 1, 25123, Brescia
Azienda Ospedaliero Universitaria Delle Marche
4112:Clinica Oncologica, Via Conca 71, 60126, Ancona
Istituto Europeo Di Oncologia S.r.l.
4113:Unità di Ginecologia OncologicUnità Operativa di Ginecologia e Ostetricia I, Via Giuseppe Ripamonti 435, 20141, Milan
Universita Cattolica Del Sacro Cuore
4105:Ginecologia oncologica, Largo Agostino Gemelli 8, 00168, Rome
Istituto Di Candiolo Fondazione Del Piemonte Per L'Oncologia IRCCS
4104:Day Hospital Oncologico, Strada Provinciale 142 Orba Km 3,95, 10060, Candiolo
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
4108:SSD Oncol.Med. Addarii-Zamagni, Via Pietro Albertoni 15, 40138, Bologna
Azienda Ospedaliera Per L'Emergenza Cannizzaro
4110:Ginecologia oncologica, Via Messina 829, 95126, Catania

Poland

6 sites · Ongoing, recruiting
Uniwersytecki Szpital Kliniczny W Poznaniu
5701:Oddzial Ginekologii Onkologicznej, Ul. Augustyna Szamarzewskiego 84, 60-569, Poznan
Bialostockie Centrum Onkologii Im. Marii Sklodowskiej-Curie W Bialymstoku
5702:Oddzial Onkologii Ginekologicznej, Ul. Ogrodowa 12, 15-027, Bialystok
Wielkopolskie Centrum Onkologii Im. Marii Sklodowskiej-Curie
5708:Oddzial Radioterapii i Onkologii Ginekologicznej, Ul. Garbary 15, 61-866, Poznan
Centrum Onkologii Ziemi Lubelskiej Im. Sw. Jana Z Dukli
5707:I Oddzial Ginekologii Onkologicznej COZL, Ul. Dra Kazimierza Jaczewskiego 7, 20-090, Lublin
Wojewodzki Szpital Specjalistyczny W Olsztynie
5706:Oddzial Ginekologii Onkologicznej, Ul. Zolnierska 18, 10-561, Olsztyn
NZOZ Innowacyjna Medycyna Read-Gene S.A.
5705, Ul. Alabastrowa 8, 72-003, Grzepnica

Portugal

2 sites · Ongoing, recruiting
Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E.
5801:Anesthesiology/Reanimation, Rua Dr. Antonio Bernardino De Almeida, 4200-072, Porto
Unidade Local De Saude De Santa Maria E.P.E.
5802: Oncologia, Avenida Professor Egas Moniz, 1649-035, Lisbon

Slovenia

1 site · Ongoing, recruiting
Institute Of Oncology Ljubljana
6801: Oncology, Zaloska Cesta 2, 1000, Ljubljana

Spain

11 sites · Ongoing, recruiting
Hospital Universitario Donostia
7021: Oncologia, Pasealeku Doct. Begiristain 109, 20014, Donostia
Hospital Universitario Reina Sofia
7020: Oncología Medica, Avenida Menendez Pidal S/n, 14004, Cordoba
Hospital Universitari Vall D Hebron
7010: Oncología Médica, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Hospital Universitario Virgen De Las Nieves
7012: Oncología Medica, Avenida De Las Fuerzas Armadas 2, 18014, Granada
Clinica Universidad De Navarra
7017: Oncología, Calle Marquesado De Santa Marta 1, 28027, Madrid
Clinica Universidad De Navarra
7011: Oncología Medica, Pio XII Etorbidea 36, 31008, Pamplona
Complexo Hospitalario Universitario De Vigo
7009: Oncología Médica, Estrada Clara Campoamor N 341, 36312, Vigo
Institut Catala D'oncologia
7007: Oncología Médica, Carretera Canyet S/n, 08916, Badalona
Hospital Universitario Y Politecnico La Fe
7001: Oncología, Avenida De Fernando Abril Martorell 106, 46026, Valencia
Hospital Universitario Miguel Servet
7003: Oncología, Paseo De Isabel La Catolica 1-3, 50009, Zaragoza
Institut Catala D'oncologia
7006: Oncologia, Avinguda De La Gran Via De L'hospitalet 199-203, 08908, L'hospitalet De Llobregat

Sweden

1 site · Ongoing, recruiting
Skanes University Hospital
7201:Hematology, Oncology and Radiation Physics, Klinikgatan 5, 221 85, Lund

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Country Trial startTrial end Recruitment startRecruitment end Early termination
Belgium 2021-12-10 2021-12-10
Bulgaria 2021-06-28 2021-06-28
Czechia 2021-07-22 2021-07-22
France 2021-11-18 2021-11-18
Germany 2021-09-21 2021-09-21
Hungary 2021-07-07 2021-07-07
Italy 2021-07-23 2021-07-23
Poland 2021-08-18 2021-08-18
Portugal 2022-02-22 2022-02-22
Slovenia 2022-02-28 2022-02-28
Spain 2021-09-06 2021-09-06
Sweden 2021-11-18 2021-11-18

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 47 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

TypeTitleVersion
Protocol (for publication) D1_Protocol Main English D0817C00098 Public 4.0
Protocol (for publication) D1_Protocol Substudy English D0817C00098 Public 7.0
Recruitment arrangements (for publication) K1_CZE Recruitment Procedure Description D0817C00098 Public 1.0
Recruitment arrangements (for publication) K1_PRT Regulatory Filenote D0817C00098 NA
Recruitment arrangements (for publication) K1_Recruitment arrangement Filenote D0817C00098 NA
Recruitment arrangements (for publication) K1_Recruitment arrangements IRB-IEC Filenote D0817C00098 NA
Recruitment arrangements (for publication) K1_Recruitment Arrangements Transition Filenote D0817C00098 NA
Recruitment arrangements (for publication) K1_Recruitment Arrangements Transition Filenote D0817C00098 NA
Recruitment arrangements (for publication) K1_Recruitment arrangements Transition Placeholder D0817C00098 NA
Recruitment arrangements (for publication) K1_Recruitment arrangements Transition Placeholder D0817C00098 NA
Recruitment arrangements (for publication) K1_Recruitment arrangements Transition Placeholder D0817C00098 NA
Recruitment arrangements (for publication) K1_Recruitment arrangements Transition placeholder D0817C00098 NA
Recruitment arrangements (for publication) K1_Recruitment Arrangements Transition Placeholder D0817C00098 NA
Recruitment arrangements (for publication) K1_Recruitment arrangements Transition Placeholder D0817C00098 NA
Subject information and informed consent form (for publication) L1_BEL Country ICF Main Dutch D0817C00098 Public 4.0
Subject information and informed consent form (for publication) L1_BEL Country ICF Main English D0817C00098 Public 4.0
Subject information and informed consent form (for publication) L1_BEL Country ICF Main French D0817C00098 Public 4.0
Subject information and informed consent form (for publication) L1_BGR Country ICF Main Bulgarian D0817C00098 Public 6.0
Subject information and informed consent form (for publication) L1_BGR Country ICF Main English D0817C00098 Public 6.0
Subject information and informed consent form (for publication) L1_BGR Country ICF Other Pregnant Partner ICF Bulgarian D0817C00098 Public 2.0
Subject information and informed consent form (for publication) L1_BGR Country ICF Other Pregnant Partner ICF English D0817C00098 Public 2.0
Subject information and informed consent form (for publication) L1_CZE Country ICF Main Adult Already enrolled patients Czech D0817C00098 Public 6.0
Subject information and informed consent form (for publication) L1_CZE Country ICF Main Adult Czech D0817C00098 Public 6.0
Subject information and informed consent form (for publication) L1_CZE Country ICF Other Adult Pregnant Participant Czech D0817C00098 Public 2.0
Subject information and informed consent form (for publication) L1_CZE Country ICF Other Adult Pregnant Partner Czech D0817C00098 Public 2.0
Subject information and informed consent form (for publication) L1_CZE Country ICF Privacy Adult Czech D0817C00098 Public 2.0
Subject information and informed consent form (for publication) L1_CZE Subject Participation Card Czech D0817C00098 Public 2.1
Subject information and informed consent form (for publication) L1_DEU ICF Main German D0817C00098 Public 5.0
Subject information and informed consent form (for publication) L1_FRA ICF Main French D0817C00098 Public 4.1
Subject information and informed consent form (for publication) L1_HUN Country ICF Main Adult Hungarian D0817C00098 Public 6.0
Subject information and informed consent form (for publication) L1_HUN Country ICF Main Adult Patient Information Sheet Hungarian D0817C00098 Public 6.0
Subject information and informed consent form (for publication) L1_HUN Country ICF Other Adult Pregnant Partn Patient Information Sheet Hungarian D0817C00098 Public 2.0
Subject information and informed consent form (for publication) L1_HUN Country ICF Other Adult Pregnant Partner Informed Consent Form Hungarian D0817C00098 Public 2.0
Subject information and informed consent form (for publication) L1_HUN Subject Participation Card Subject ID Card Hungarian D0817C00098 Public 2.0
Subject information and informed consent form (for publication) L1_HUN Subject Participation Card Subject ID Justification Letter English D0817C00098 Public 1.0
Subject information and informed consent form (for publication) L1_ITA Country ICF Main Italian D0817C00098 Public 6.0
Subject information and informed consent form (for publication) L1_ITA Country ICF Other Italian D0817C00098 Public 2.0
Subject information and informed consent form (for publication) L1_ITA Country IRB-IEC Additional-Amendment Approval PP Italian D0817C00098 Public 2.0
Subject information and informed consent form (for publication) L1_ITA Country IRB-IEC Additional-Amendment Approval PT Material-Main ICF Italian D0817C00098 Public 6.0
Subject information and informed consent form (for publication) L1_POL Country ICF Main Polish D0817C00098 Public 6.0
Subject information and informed consent form (for publication) L1_POL Country ICF Other Pregnant Partner Polish D0817C00098 Public 2.0
Subject information and informed consent form (for publication) L1_PRT Country ICF Procedure English D0817C00098 1.0
Subject information and informed consent form (for publication) L1_Regulatory Filenote D0817C00098 Public NA
Subject information and informed consent form (for publication) L1_Study ICF Main Portuguese D0817C00098 Public 4.0
Subject information and informed consent form (for publication) L1_SVN ICF Country Main Slovenian D0817C00098 Public 5.0
Subject information and informed consent form (for publication) L1_SWE Country ICF Main Appendix 1 Swedish D0817C00098 Public 3.0
Subject information and informed consent form (for publication) L1_SWE Country ICF Main Swedish D0817C00098 Public 4.0

Application history

5 submissions — initial application plus substantial / non-substantial modifications

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2024-07-16 Czechia Acceptable with conditions
2024-08-13
 2024-08-13
2 SUBSTANTIAL MODIFICATION SM-1 2024-10-09 Acceptable with conditions 2024-11-19
3 NON SUBSTANTIAL MODIFICATION NSM-1 2025-01-09 Acceptable with conditions 2025-01-09
4 SUBSTANTIAL MODIFICATION SM-2 2025-02-20 Czechia Acceptable with conditions 2025-03-28
5 SUBSTANTIAL MODIFICATION SM-3 2025-05-06 Acceptable with conditions 2025-05-28

Related clinical trials