Clinical trial • Phase III • Oncology
CAPIVASERTIB for Metastatic hormone-sensitive prostate cancer (PTEN deficiency)
Phase III trial of CAPIVASERTIB for Metastatic hormone-sensitive prostate cancer (PTEN deficiency).
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Metastatic hormone-sensitive prostate cancer (PTEN deficiency)
- Trial Stage
- Phase III
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 07-05-2024
- First CTIS Authorization Date
- 21-06-2024
Trial design
Randomised, placebo + abiraterone versus capivasertib + abiraterone (no doses/schedules specified in ctis record)-controlled Phase III trial in France, Spain, Czechia and others.
- Randomised
- Yes
- Comparator
- Placebo + Abiraterone versus Capivasertib + Abiraterone (no doses/schedules specified in CTIS record)
- Biomarker Stratified
- True, biomarker: PTEN deficiency (centralised PTEN IHC)
- Target Sample Size
- 741
Eligibility
Recruits 741 No vulnerable population selected. Trial enrols adult male patients only; informed consent required from participants. Separate subject information and informed consent forms and addenda exist for biomarker testing, genetic research and pregnant partners (country-specific ICFs available). No paediatric consent/assent provisions (not applicable)..
- Vulnerable Population
- No vulnerable population selected. Trial enrols adult male patients only; informed consent required from participants. Separate subject information and informed consent forms and addenda exist for biomarker testing, genetic research and pregnant partners (country-specific ICFs available). No paediatric consent/assent provisions (not applicable).
Inclusion criteria
- {"criterion_text":"- 1. Asymptomatic or mildly symptomatic, histologically-confirmed de novo metastatic hormone-sensitive prostate adenocarcinoma without small cell tumours\n- 2. Consent to provide a FFPE tissue block (preferred) or slides. Tissue from bone metastases is not acceptable\n- 3. A valid PTEN IHC result indicating PTEN deficiency (centralized testing)\n- 4. Metastatic disease documented prior to randomisation by clear evidence of ≥ 1 bone lesion and/or ≥ 1 soft tissue lesion accurately assessed at baseline and suitable for repeated assessment with CT and/or MRI. PSMA PET identification only will not be eligible\n- 5. Candidate for abiraterone and steroid therapy\n- 6. Ongoing ADT with GnRH analogue, or LHRH agonists or antagonist, or bilateral orchiectomy\n- 7. Eastern Cooperative Oncology Group (ECOG)/WHO performance status 0 to 1 with no deterioration over the previous 2 weeks and minimum life expectancy of 12 weeks\n- 8. Able and willing to swallow and retain oral medication\n- 9. 7 day Brief Pain Inventory-Short Form (BPI-SF) and Brief Fatigue Inventory(BFI) questionnaires and the analgesic diary during screening completed\n- 10. Agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm"}
Exclusion criteria
- {"criterion_text":"- 1.Prior radical prostatectomy or definitive radiotherapy (RT) with therapeutic intent for prostate cancer. Palliative RT is allowed within 4 wks before start of study \n- 2.Major surgery within 4 wks of start of study \n- 3.Brain metastases, or spinal cord compression (unless asymptomatic, treated and stable \n- 4 Past medical history or evidence of ongoing interstitial lung disease or radiation pneumonitis requiring steroids \n- 5.Any of the following cardiac criteria: -Mean resting QTc >470 msec -History of QT prolongation associated with other medications that required discontinuation - Family history of long QT syndrome or unexplained sudden death under the age of 40 - Medical history significant for arrhythmia, symptomatic or requiring treatment; symptomatic or uncontrolled atrial fibrillation; or asymptomatic sustained ventricular tachycardia - Any clinically important abnormalities of resting ECG - Factors that increase the risk of QTc prolongation or of arrhythmic events, or any concomitant medication known to significantly prolong the QT interval and associated with Torsade de Pointes - Experience of any of the following in the preceding 3 months: coronary artery bypass graft, angioplasty, myocardial infarction or unstable angina pectoris - Congestive heart failure NYHA Grade ≥2 - Symptomatic hypotension (SBP<90 mmHg and/or DBP<50mmHg)or uncontrolled hypertension (SBP ≥160 mmHg or DBP ≥95 mmHg) \n- 6. Any of following clinically significant abnormalities of glucose metabolism: - Patients with diabetes mellitus type 1 or 2 requiring insulin - HbA1c ≥8.0% (63.9 mmol/mol) \n- 7. Inadequate bone marrow reserve or organ function: - Neutrophils <1.5x109/L - Platelets <100x109/L - Hb <9g/dL (<5.59 mmol/L) - ALT and AST >2.5x ULN if no liver metastases or >5x ULN if liver metastases - Bilirubin >1.5x ULN - CrCL <50 mL/min \n- 8. Severe or uncontrolled systemic diseases, including active bleeding diatheses, active infection including hepatitis B and C. diagnosis with HIV or a history of an AIDS opportunistic infection within the past 12 months \n- 9. Unevaluable for both bone and soft tissue progression as defined by the following : bone \"superscan\" and no soft tissue lesion evaluable by RECIST \n- 10.Conditions that would preclude adequate absorption of capivasertib\n- 11. Any other clinical finding that, gives reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug\n- 12. Evidence of dementia, altered mental status, or any psychiatric condition prohibiting understanding or rendering of informed consent\n- 13. Previous allogeneic bone marrow or solid organ transplant \n- 14. History of another primary malignancy except for malignancy treated with curative intent with no known disease ≥ 2 years before starting study and of low recurrence risk \n- 15. Following treatments: - Nitrosourea or mitomycin C within 6 wks of the start of study - Any other anticancer therapy or immunosuppressant medication (other than corticosteroids) within 3 wks of the start of study - Strong inhibitors or inducers of CYP3A4 within 2 wks before the start of study - Drugs known to prolong the QT interval and associated with torsades de pointes within 5 T½of the start of the study \n- 16. Participation in another clinical study with an investigational product administered in the last 30 days or 5 half-lives whichever is longer \n- 17. History of hypersensitivity to active or inactive excipients of capivasertib, abiraterone, or drugs with a similar chemical structure or class \n- 18. Involvement in the planning and/or conduct of the study \n- 19. Judgment by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study requirements \n- 20. Any restriction or contraindication based on the local prescribing information that would prohibit the use of abiraterone"}
Endpoints
Primary endpoints
- {"endpoint_text":"- 1.Radiographic Progression-free Survival (rPFS) in patients with PTENdeficient Per Response Evaluation Criteria in Solid Tumors Version 1.1(RECIST 1.1) for soft tissue and/or Prostate Cancer Working Group 3(PCWG3) for bone as Assessed by the Investigator","definition_or_measurement_approach":"Assessment by the investigator of radiographic progression-free survival (rPFS) using RECIST v1.1 for soft tissue lesions and PCWG3 criteria for bone lesions."}
Secondary endpoints
- {"endpoint_text":"- 1.To compare the effect of capivasertib+abiraterone relative to placebo+abiraterone by assessment of overall survival","definition_or_measurement_approach":"Assessment of overall survival (time from randomisation to death from any cause) as a comparison between treatment arms."}
- {"endpoint_text":"- 2.To compare the effect of capivasertib+abiraterone relative to placebo+abiraterone by assessment of time to start of first subsequent therapy or death (TFST)","definition_or_measurement_approach":"Time to start of first subsequent therapy or death (TFST) as assessed for each participant."}
- {"endpoint_text":"- 3.To compare the effect of capivasertib+abiraterone relative to placebo+abiraterone by assessment of time to start symptomatic skeletal event-free survival (SSE-FS)","definition_or_measurement_approach":"Time until symptomatic skeletal event or death (SSE-FS) compared between arms."}
- {"endpoint_text":"- 4.To compare the effect of capivasertib+abiraterone relative to placebo+abiraterone by assessment of time to pain progression (TTPP)","definition_or_measurement_approach":"Time to pain progression (TTPP) as measured by patient-reported assessments and analgesic diary/questionnaires."}
- {"endpoint_text":"- 5.To compare the effect of capivasertib+abiraterone relative to placebo+abiraterone by assessment of time to PSA progression","definition_or_measurement_approach":"Time to PSA progression as defined by protocol-specified PSA criteria."}
- {"endpoint_text":"- 6.To compare the effect of capivasertib+abiraterone relative to placebo+abiraterone by assessment of progression-free survival after next-line treatment (PFS2) 7.To evaluate the PK of capivasertib in combination with abiraterone","definition_or_measurement_approach":"PFS2: progression-free survival after next-line treatment; PK: pharmacokinetic evaluation of capivasertib when combined with abiraterone."}
Recruitment
- Planned Sample Size
- 741
- Recruitment Window Months
- 34
- Consent Approach
- Informed consent is obtained from adult participants. Subject Information Sheets and Informed Consent Forms are available in multiple country-specific versions (examples in CTIS: English, French, Spanish, Polish, Dutch, Slovak, Bulgarian). Separate ICFs/addenda exist for biomarker status determination, genetic research, pregnant partners and handling personal data. No paediatric assent procedures (adults only).
Geography
- Total Number Of Sites
- 65
- Total Number Of Participants
- 271
France
- Earliest CTIS Part Ii Submission Date
- 30-05-2024
- Latest Decision Or Authorization Date
- 03-03-2026
- Processing Time Days
- 642
- Number Of Sites
- 12
- Number Of Participants
- 38
Sites
- Site Name
- Institut Bergonie
- Department Name
- Oncology
- Contact Person Name
- Guilhem ROUBAUD
- Contact Person Email
- g.roubaud@bordeaux.unicancer.fr
- Site Name
- Hospices Civils De Lyon
- Department Name
- Oncology
- Contact Person Name
- Sophie TARTAS
- Contact Person Email
- sophie.tartas@chu-lyon.fr
- Site Name
- Besancon University Hospital Center
- Department Name
- Oncology
- Contact Person Name
- Tristan MAURINA
- Contact Person Email
- t1maurina@chu-besancon.fr
- Site Name
- Institut Regional Du Cancer De Montpellier
- Department Name
- Oncology
- Contact Person Name
- Diego TOSI
- Contact Person Email
- Diego.Tosi@icm.unicancer.fr
- Site Name
- Les Hopitaux Universitaires De Strasbourg
- Department Name
- Oncology
- Contact Person Name
- Philippe BARTHELEMY
- Contact Person Email
- p.barthelemy@icans.eu
- Site Name
- Institut Mutualiste Montsouris
- Department Name
- Oncology
- Contact Person Name
- Raphael COLLE
- Contact Person Email
- raphael.colle@imm.fr
- Site Name
- Institut Paoli Calmettes
- Department Name
- Oncology
- Contact Person Name
- Gwenaelle GRAVIS
- Contact Person Email
- GRAVISG@ipc.unicancer.fr
- Site Name
- Centre Hospitalier Universitaire De Rennes
- Department Name
- Urology
- Contact Person Name
- Romain MATHIEU
- Contact Person Email
- romain.MATHIEU@chu-rennes.fr
- Site Name
- Centre Hospitalier Intercommunal De Cornouaille
- Department Name
- Oncology
- Contact Person Name
- Josselin ANNIC
- Contact Person Email
- josselin.annic@ch-cornouaille.fr
- Site Name
- Hospital Foch
- Department Name
- Oncology
- Contact Person Name
- Raffaele RATTA
- Contact Person Email
- r.ratta@hopital-foch.com
- Site Name
- Centre Antoine Lacassagne
- Department Name
- Oncology
- Contact Person Name
- Delphine BORCHIELLINI
- Contact Person Email
- Delphine.BORCHIELLINI@nice.unicancer.fr
- Site Name
- Institut Gustave Roussy
- Department Name
- Oncology
- Contact Person Name
- Alice BERNARD-TESSIER
- Contact Person Email
- alice.bernard-tessier@gustaveroussy.fr
Spain
- Earliest CTIS Part Ii Submission Date
- 30-05-2024
- Latest Decision Or Authorization Date
- 04-03-2026
- Processing Time Days
- 643
- Number Of Sites
- 10
- Number Of Participants
- 69
Sites
- Site Name
- Hospital Clinico San Carlos
- Department Name
- Oncology
- Contact Person Name
- Javier Puente Vazquez
- Contact Person Email
- javier.puente@salud.madrid.org
- Site Name
- Hospital De La Santa Creu I Sant Pau
- Department Name
- Oncology
- Contact Person Name
- Jose Pablo Maroto Rey
- Contact Person Email
- JMaroto@santpau.cat
- Site Name
- Hospital Universitario Central De Asturias
- Department Name
- Oncology
- Contact Person Name
- Carlos Alvarez Fernandez
- Contact Person Email
- carlos.alvfer@gmail.com
- Site Name
- Hospital Universitario Marques De Valdecilla
- Department Name
- Oncology
- Contact Person Name
- Ignacio Duran Martinez
- Contact Person Email
- ignacioduranmartinez@gmail.com
- Site Name
- Hospital Universitario Virgen De La Macarena
- Department Name
- Oncology
- Contact Person Name
- Alberto Sanchez Camacho Mejias
- Contact Person Email
- sanchezmejias@hotmail.es
- Site Name
- Hospital Universitario Ramon Y Cajal
- Department Name
- Oncology
- Contact Person Name
- Teresa Alonso Gordoa
- Contact Person Email
- talonsogordoa@gmail.com
- Site Name
- Hospital General Universitario Gregorio Maranon
- Department Name
- Oncology
- Contact Person Name
- Jose Angel Arranz Arija
- Contact Person Email
- jarranza.oncomed@gmail.com
- Site Name
- Institut Catala D'oncologia
- Department Name
- Oncology
- Contact Person Name
- Alberto Font Pous
- Contact Person Email
- afont@iconcologia.net
- Site Name
- Complejo Hospitalario Universitario Insular Materno Infantil
- Department Name
- Oncology
- Contact Person Name
- Alfonso Gomez de Liaño Lista
- Contact Person Email
- agomezdeliano84@gmail.com
- Site Name
- Hospital Universitario 12 De Octubre
- Department Name
- Oncology
- Contact Person Name
- Daniel Castellano Gauna
- Contact Person Email
- cdanicas@hotmail.com
Czechia
- Earliest CTIS Part Ii Submission Date
- 30-05-2024
- Latest Decision Or Authorization Date
- 02-03-2026
- Processing Time Days
- 641
- Number Of Sites
- 6
- Number Of Participants
- 13
Sites
- Site Name
- Urocentrum Praha s.r.o.
- Contact Person Name
- Michaela Matouskova
- Contact Person Email
- matouskova@urocentrum.cz
- Site Name
- Fakultni Nemocnice Bulovka
- Department Name
- Ustav Radiacni Onkologie
- Contact Person Name
- Petra Holeckova
- Contact Person Email
- petra.holeckova@bulovka.cz
- Site Name
- Fakultni Nemocnice U Sv Anny V Brne
- Department Name
- Onkologicko-chirurgicke oddeleni
- Contact Person Name
- Jana Katolicka
- Contact Person Email
- jana.katolicka@fnusa.cz
- Site Name
- Fakultni Nemocnice Kralovske Vinohrady
- Department Name
- Radioterapeuticka a onkologicka klinika
- Contact Person Name
- Jan Dvorak
- Contact Person Email
- jan.dvorak@fnkv.cz
- Site Name
- Fakultni Nemocnice Hradec Kralove
- Department Name
- Klinika onkologie a radioterapie
- Contact Person Name
- Jiri Petera
- Contact Person Email
- jiri.petera@fnhk.cz
- Site Name
- NH Hospital a.s.
- Department Name
- Onkologicke oddeleni
- Contact Person Name
- Martin Smakal
- Contact Person Email
- msmakal@gmail.com
Belgium
- Earliest CTIS Part Ii Submission Date
- 30-05-2024
- Latest Decision Or Authorization Date
- 02-03-2026
- Processing Time Days
- 641
- Number Of Sites
- 4
- Number Of Participants
- 20
Sites
- Site Name
- Az Maria Middelares Gent
- Department Name
- Medical Oncology
- Contact Person Name
- Christof Vulsteke
- Contact Person Email
- Christof.Vulsteke@mijnziekenhuis.be
- Site Name
- Universitair Ziekenhuis Gent
- Department Name
- Urologie
- Contact Person Name
- Nicolaas Lumen
- Contact Person Email
- Nicolaas.Lumen@UZGENT.be
- Site Name
- Institut Jules Bordet
- Department Name
- Medical Oncology
- Contact Person Name
- Nieves Martinez-Chanzá
- Contact Person Email
- nieves.martinez-chanza@hubruxelles.be
- Site Name
- Algemeen Ziekenhuis Groeninge
- Department Name
- Urologie
- Contact Person Name
- Karl Lesage
- Contact Person Email
- karl.lesage@azgroeninge.be
Bulgaria
- Earliest CTIS Part Ii Submission Date
- 30-05-2024
- Latest Decision Or Authorization Date
- 05-03-2026
- Processing Time Days
- 644
- Number Of Sites
- 4
- Number Of Participants
- 21
Sites
- Site Name
- University Specialized Hospital For Active Treatment In Oncology EAD
- Department Name
- Clinic of medical oncology
- Contact Person Name
- Assia Konsoulova
- Contact Person Email
- Dr.konsoulova@gmail.com
- Site Name
- UMHAT Sofiamed OOD
- Department Name
- Medical oncology
- Contact Person Name
- Velko Minchev
- Contact Person Email
- v_minchev@abv.bg
- Site Name
- Complex Oncological Center Plovdiv EOOD
- Department Name
- Department of medical oncology and oncology gastroenterology diseases
- Contact Person Name
- Antoaneta Tomova
- Contact Person Email
- dr.tomova@gmail.com
- Site Name
- Multiprofessional Hospital For Active Treatment Park Hospital Ltd.
- Department Name
- Department of medical oncology
- Contact Person Name
- Vladimir Kanarev
- Contact Person Email
- kanarevi@abv.bg
Slovakia
- Earliest CTIS Part Ii Submission Date
- 30-05-2024
- Latest Decision Or Authorization Date
- 02-03-2026
- Processing Time Days
- 641
- Number Of Sites
- 6
- Number Of Participants
- 23
Sites
- Site Name
- Uroexam spol. s r.o.
- Department Name
- Outpatient Care of Urology
- Contact Person Name
- Marek Brezovský
- Contact Person Email
- uroexam@gmail.com
- Site Name
- Milab s.r.o.
- Department Name
- Outpatient Care of Urology
- Contact Person Name
- Ivan Minčík
- Contact Person Email
- mincik@fnsp.presov.sk
- Site Name
- Urocentrum Sala s.r.o.
- Department Name
- Outpatient Care of Urology
- Contact Person Name
- Richard Polák
- Contact Person Email
- risiak333@gmail.com
- Site Name
- URO clinic s.r.o.
- Contact Person Name
- Boris Kollárik
- Contact Person Email
- bkollarik@gmail.com
- Site Name
- Privatna Urologicka Ambulancia s.r.o.
- Department Name
- Outpatient Care of Urology
- Contact Person Name
- Roman Sokol
- Contact Person Email
- roman.sokol@urology.sk
- Site Name
- Cuimed s.r.o.
- Department Name
- Outpatient Care of Urology
- Contact Person Name
- Frederico Goncalves
- Contact Person Email
- cuimed1@gmail.com
Poland
- Earliest CTIS Part Ii Submission Date
- 30-05-2024
- Latest Decision Or Authorization Date
- 07-03-2026
- Processing Time Days
- 646
- Number Of Sites
- 9
- Number Of Participants
- 38
Sites
- Site Name
- Clinical Research Center Sp. z o.o. Medic-R sp.k.
- Contact Person Name
- Ilona Bar-Letkiewicz
- Contact Person Email
- ilona.bar-letkiewicz@cr-center.pl
- Site Name
- Uniwersyteckie Centrum Kliniczne
- Department Name
- Klinika Onkologii i Radioterapii
- Contact Person Name
- Renata Zaucha
- Contact Person Email
- rzaucha@gumed.edu.pl
- Site Name
- Szpital Kliniczny Ministerstwa Spraw Wewnetrznych I Administracji Z Warminsko-Mazurskim Centrum Onkologii W Olsztynie
- Department Name
- Oddzial Kliniczny Onkologii i Immunoonkologii z Osrodkiem Dziennym Terapii Onkologicznej
- Contact Person Name
- Karolina Zukowska
- Contact Person Email
- karolina.gornowicz@wp.pl
- Site Name
- Szpital Grochowski Im.Dr Med. Rafała Masztaka Sp. z o.o.
- Department Name
- Oddzial Chemioterapii
- Contact Person Name
- Iwona Skoneczna
- Contact Person Email
- iskoneczna@grochowski.waw.pl
- Site Name
- Szpital Wojewodzki Im. Mikolaja Kopernika W Koszalinie
- Department Name
- Oddzial Dzienny Chemioterapii
- Contact Person Name
- Mariusz Kwiatkowski
- Contact Person Email
- mariusz.kwiatkowski@swk.med
- Site Name
- Nasz Lekarz Przychodnie Medyczne Sp. z o.o.
- Contact Person Name
- Przemyslaw Adamczyk
- Contact Person Email
- przemekad@poczta.onet.pl
- Site Name
- Centrum Medyczne Medyk Sp. z o.o.
- Contact Person Name
- Kamil Kuc
- Contact Person Email
- kkuc@wszp.pl
- Site Name
- Centrum Onkologii Im. Prof. Franciszka Lukaszczyka W Bydgoszczy
- Department Name
- Ambulatorium Chemioterapii i Oddzial Kliniczny Radioterapii
- Contact Person Name
- Bogdan Zurawski
- Contact Person Email
- zurawskib@co.bydgoszcz.pl
- Site Name
- Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
- Department Name
- Klinika Nowotworow Ukladu Moczowego
- Contact Person Name
- Pawel Wiechno
- Contact Person Email
- wiechno@gmail.com
Netherlands
- Earliest CTIS Part Ii Submission Date
- 30-05-2024
- Latest Decision Or Authorization Date
- 16-03-2026
- Processing Time Days
- 655
- Number Of Sites
- 5
- Number Of Participants
- 27
Sites
- Site Name
- Elisabeth-Tweesteden Ziekenhuis
- Department Name
- Interne Geneeskunde
- Contact Person Name
- Robbert van Alphen
- Contact Person Email
- r.vanalphen@etz.nl
- Site Name
- Bravis Ziekenhuis
- Department Name
- Interne/Oncologie centrum
- Contact Person Name
- Steve Boudewijns
- Contact Person Email
- s.boudewijns@bravis.nl
- Site Name
- Tergooiziekenhuizen
- Department Name
- Interne Geneeskunde
- Contact Person Name
- Pieter van den Berg
- Contact Person Email
- PvandenBerg@tergooi.nl
- Site Name
- St. Antonius Ziekenhuis
- Department Name
- Interne Geneeskunde
- Contact Person Name
- Jarmo Hunting
- Contact Person Email
- j.hunting@antoniusziekenhuis.nl
- Site Name
- Haga Hospital
- Department Name
- Interne/Oncologie
- Contact Person Name
- Daniel Houtsma
- Contact Person Email
- d.houtsma@hagaziekenhuis.nl
Germany
- Earliest CTIS Part Ii Submission Date
- 30-05-2024
- Latest Decision Or Authorization Date
- 04-03-2026
- Processing Time Days
- 643
- Number Of Sites
- 9
- Number Of Participants
- 22
Sites
- Site Name
- Charite Research Organisation GmbH
- Department Name
- Uro-Onkologisches Studiendepartment
- Contact Person Name
- Maria de Santis
- Contact Person Email
- maria.de-santis@charite.de
- Site Name
- Universitaetsklinikum Muenster AöR
- Department Name
- Klinik für Urologie und Kinderurologie
- Contact Person Name
- Martin Boegemann
- Contact Person Email
- uroonkologie@ukmuenster.de
- Site Name
- Klinikum Nuernberg
- Department Name
- Onkologie/ Haematologie
- Contact Person Name
- Marinela Augustin
- Contact Person Email
- marinela.augustin@klinikum-nuernberg.de
- Site Name
- Urologie Neandertal
- Department Name
- Urologie
- Contact Person Name
- Philipp Spiegelhalder
- Contact Person Email
- mettmann@urologie-neandertal.de
- Site Name
- Urologische Gemeinschaftspraxis
- Department Name
- Urologie
- Contact Person Name
- Miguel Garcia Schuermann
- Contact Person Email
- dr.garcia@urologie-wesel.de
- Site Name
- Marien Hospital Herne Universitatsklinikum Der Ruhr-Universitat Bochum
- Department Name
- Klinik für Urologie
- Contact Person Name
- Florian Roghmann
- Contact Person Email
- Florian.Roghmann@elisabethgruppe.de
- Site Name
- Studienpraxis Urologie Susan Feyerabend MD Tilman Todenhoefer MD PhD GbR
- Department Name
- Urologie
- Contact Person Name
- Susan Feyerabend
- Contact Person Email
- praxis@studienurologie.de
- Site Name
- University Medical Center Hamburg-Eppendorf
- Department Name
- Studienbetreuung der Martini Klinik am UKE GmbH
- Contact Person Name
- Thomas Steuber
- Contact Person Email
- steuber@uke.de
- Site Name
- Urologicum Duisburg
- Department Name
- Urologie
- Contact Person Name
- Eva Hellmis
- Contact Person Email
- praxis@urologicum-duisburg.de
Sponsor
Primary sponsor
- Full Name
- AstraZeneca AB
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Sweden
Third parties
- {"country":"Sweden","full_name":"AstraZeneca AB","duties_or_roles":"Monetary support","organisation_type":"Pharmaceutical company"}
- {"country":"","full_name":"Astrazeneca K.K.","duties_or_roles":"Monetary support","organisation_type":""}
Investigational products
- Investigational Product Name
- Capivasertib
- Active Substance
- CAPIVASERTIB
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Authorisation Status
- prodAuthStatus: 1
- Investigational Product Name
- ABIRATERONE ACETATE
- Active Substance
- ABIRATERONE ACETATE
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Authorisation Status
- prodAuthStatus: 2
- Investigational Product Name
- Placebo for capivasertib film-coated tablet for oral use
- Modality
- Other
- Combination Treatment
- Yes
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