Clinical trial • Phase III • Oncology
CAPIVASERTIB for Metastatic castration-resistant prostate cancer
Phase III trial of CAPIVASERTIB for Metastatic castration-resistant prostate cancer.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Metastatic castration-resistant prostate cancer
- Trial Stage
- Phase III
- Drug Modality
- Small molecule|Small molecule
Key dates
- Initial CTIS Submission Date
- 12-07-2024
- First CTIS Authorization Date
- 06-08-2024
Trial design
Randomised, placebo + docetaxel (placebo to capivasertib; docetaxel intravenous formulation; docetaxel dosing info in product dictionary: max daily dose 75 mg/m2)-controlled, adaptive Phase III trial in Netherlands, Greece, Czechia and others.
- Randomised
- Yes
- Comparator
- placebo + docetaxel (Placebo to capivasertib; docetaxel intravenous formulation; docetaxel dosing info in product dictionary: max daily dose 75 mg/m2)
- Adaptive
- True, Interim futility analysis planned per Clinical Study Protocol v5.0: an interim futility analysis to be performed when the predefined number of overall survival events have accumulated; the Independent Data Monitoring Committee (IDMC) reviews unblinded interim data and informs the sponsor whether interim futility boundaries are met; recommendation to stop the trial for futility if both dual primary endpoints are in their futility regions, with final decision by the sponsor (AstraZeneca).
- Target Sample Size
- 951
Eligibility
Recruits 951 No vulnerable population selected (isVulnerablePopulationSelected=false). Trial enrols adult male patients only; informed consent is to be provided by the participant. No assent or minor consent handling is described in the CTIS record..
- Vulnerable Population
- No vulnerable population selected (isVulnerablePopulationSelected=false). Trial enrols adult male patients only; informed consent is to be provided by the participant. No assent or minor consent handling is described in the CTIS record.
Inclusion criteria
- {"criterion_text":"- Histologically-confirmed prostate adenocarcinoma without predominant neuroendocrine or small cell cancers\n- Able and willing to swallow and retain oral medication\n- Agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm\n- Metastatic disease documented prior to randomisation by clear evidence of ≥ 1 bone lesion (defined as 1 lesion with positive uptake on bone scan) and/or ≥ 1 soft tissue lesion (measurable or non measurable)\n- Patient must have been previously treated with a next generation hormonal agent (NHA), ie, abiraterone, enzalutamide, apalutamide or darolutamide, for prostate cancer for at least 3 months and shown evidence of disease progression (radiological or via PSA assessment) while receiving the NHA\n- Evidence of mCRPC with progression of disease despite androgen deprivation therapy (ADT)\n- Serum testosterone level ≤ 50 ng/dL\n- Candidate for docetaxel and steroid therapy\n- Ongoing ADT with LHRH agonist, LHRH antagonist, or bilateral orchiectomy\n- Eastern Cooperative Oncology Group (ECOG)/World Health Organisation (WHO) performance status 0 to 1 and anticipated minimum life expectancy of 12 weeks\n- Confirmation that archival formalin-fixed paraffin embedded (FFPE) tumour tissue sample which meets the minimum pathology and sample requirements is available to send to the central laboratory"}
Exclusion criteria
- {"criterion_text":"- Radiotherapy with a wide field of radiation within4 weeks before start of study treatment\n- Any other disease, finding that, in the investigator's opinion, gives reasonable suspicion of a disease or condition that contra-indicates the use of an investigational drug, may affect the interpretation of the results, render the patient at high risk from treatment complications or interferes with obtaining informed consent. Evidence of dementia, altered mental status,or any psychiatric condition that would prohibit understanding or rendering of informed consent\n- Previous allogeneic bone marrow transplant or solid organ transplant\n- History of another primary malignancy except for malignancy treated with curative intent with no known active disease ≥2 years before the first dose of study intervention and of low potential risk for recurrence. Exceptions include adequately resected non-melanoma skin cancer and curatively treated in situ disease\n- Persistent toxicities (CTCAE Grade ≥2) caused by previous anticancer therapy, excluding alopecia. Patients with irreversible toxicity that is not reasonably expected to be exacerbated by study intervention in the opinion of the investigator may be included (eg, hearing loss)\n- Treatment with any of the following: i. Prior chemotherapy for CRPC. Chemotherapy for metastatic or localized HSPC (including docetaxel) is allowed provided that chemotherapy was completed ≥ 6months before randomisation and progression of the prostate cancer occurred ≥ 6months after the completion of therapy. ii. Prior exposure to AKT inhibitors or PI3K inhibitors iv.Any other immunotherapy, immunosuppressant medication (other than corticosteroids) or anticancer agents (except ADT )within 3weeks of the first dose of study treatment v. Strong inhibitors or strong inducers of cytochrome P450 (CYP) 3A4 within2 weeks prior to the first dose of study treatment (3 weeks for St John's wort) vi. Use of any live vaccine administration 30 days prior to the initiation of the study treatment, during,and for at least 90 days after the last dose of the study treatment\n- Drugs known to significantly prolong the QT interval and associated with Torsade de Pointes within 5 half-lives of the first dose of study treatment\n- Major surgery (excl. placement of vascular access, transurethral resection of prostate, bilateral orchiectomy, internal stents) within 4 weeks of start of study treatment\n- Brain metastases, or spinal cord compression (unless spinal cord compression is asymptomatic and stable and not requiring steroids for at least 4 weeks prior to start of study treatment)\n- Any of the following cardiac criteria i. Mean resting correctedQT interval (QTc) > 470 msec from 3 consecutive ECGs ii. Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG iii. Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, hypokalaemia, potential for torsades de pointes, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years of age, or any concomitant medication known to prolong the QT interval iv. Experience of any of the following procedures or conditions in the preceding 3 months: coronary artery bypass graft, vascular stent, myocardial infarction, unstable angina pectoris, congestive heart failure NYHA Grade ≥2 v. Symptomatic hypotension -systolic bloodpressure < 90mmHg and/or diastolic bloodpressure < 50mmHg vi. Haemodynamic instability\n- Clinically significant abnormalities of glucose metabolism as defined by any of the following i. Patients with diabetes mellitus (DM) type1 or DM type 2 requiring insulin treatment ii. HbA1c ≥ 8.0% (63.9 mmol/mol)\n- Inadequate bone marrow reserve or organ function as demonstrated by laboratory values as specified in the protocol\n- As judged by the investigator, any evidence of diseases (including severe or uncontrolled systemic diseases, uncontrolled hypertension, history of interstitial pneumonia/pneumonitis or interstitial lung disease, renal transplant and active bleeding diseases), that makes it undesirable for the patient to participate in the study or that would jeopardise compliance with the protocol\n- Known to have active hepatitis B or C infection; HIV with a detectable viral RNA or a CD4+ T-cell count < 350 cells/uL or a history of an AIDS defining opportunistic infection within the past 12 months\n- Refractory nausea and vomiting, malabsorption syndrome, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection, or other condition that would preclude adequate absorption of capivasertib"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Overall survival is defined as time from randomisation until the date of death due to any cause. The comparison will include all randomised patients as randomised, regardless of whether the patient withdraws from therapy or receives another anticancer therapy.","definition_or_measurement_approach":"Overall survival (OS) defined as time from randomisation until date of death due to any cause; analysis includes all randomised patients as randomised."}
- {"endpoint_text":"- Radiographic Progression-free Survival (rPFS) 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":"rPFS assessed per RECIST v1.1 for soft tissue lesions and PCWG3 criteria for bone lesions, as assessed by the investigator."}
Secondary endpoints
- {"endpoint_text":"- OS is defined as time from randomisation until the date of death due to any cause.","definition_or_measurement_approach":"Overall survival (OS) same definition as primary OS: time from randomisation until date of death due to any cause."}
- {"endpoint_text":"- Radiographic Progression-free Survival (rPFS) 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":"rPFS per RECIST v1.1 for soft tissue and/or PCWG3 for bone, assessed by investigator."}
- {"endpoint_text":"- Time to pain progression (TTPP) based on a 2-point increase from baseline in the Brief Pain Inventory-Short Form (BPI-SF) Item 3 'worst pain in 24 hours' score and/or initiation of/increase in opioid analgesic use","definition_or_measurement_approach":"TTPP defined as a 2-point increase from baseline in BPI-SF item 3 ('worst pain in 24 hours') and/or start/increase of opioid analgesic use."}
- {"endpoint_text":"- Time to start Symptomatic Skeletal-Related Event (SSRE)","definition_or_measurement_approach":"Time to first symptomatic skeletal-related event (SSRE) measured from randomisation to first SSRE."}
- {"endpoint_text":"- Time to deterioration in urinary symptoms (TTDUS), change from baseline that reaches a clinically meaningful deterioration threshold.","definition_or_measurement_approach":"TTDUS defined as change from baseline reaching a clinically meaningful deterioration threshold in urinary symptom measures."}
- {"endpoint_text":"- Time to deterioration in Physical Functioning (TTDPF), change from baseline that reaches a clinically meaningful deterioration threshold.","definition_or_measurement_approach":"TTDPF defined as change from baseline reaching a clinically meaningful deterioration threshold in physical functioning measures."}
- {"endpoint_text":"- Change from baseline in BPI-SF worst pain score, pain severity and interference domain scores.","definition_or_measurement_approach":"Change from baseline in BPI-SF worst pain score and domain scores for pain severity and interference."}
- {"endpoint_text":"- Plasma concentration of capivasertib derived from a population PK model","definition_or_measurement_approach":"Plasma concentration of capivasertib estimated via a population pharmacokinetic (PK) model."}
Recruitment
- Planned Sample Size
- 951
- Recruitment Window Months
- 57
- Consent Approach
- Informed consent is obtained from participants (adult male patients). Subject information and informed consent forms (ICFs) are provided; multiple ICF variants and addenda are present (e.g., Main ICF, Pregnant Partner ICF, Optional Genetic, GDPR addendum, Future Research). ICF documents are available in multiple languages as provided in the CTIS documents list (examples include English, French, Spanish, Dutch, Hungarian, Polish, Greek, German, Czech). No assent or minor consent procedures are described in the CTIS record.
Geography
- Total Number Of Sites
- 57
- Total Number Of Participants
- 424
Netherlands
- Earliest CTIS Part Ii Submission Date
- 01-08-2024
- Latest Decision Or Authorization Date
- 15-04-2025
- Processing Time Days
- 258
- Number Of Sites
- 2
- Number Of Participants
- 6
Sites
- Site Name
- Spaarne Gasthuis Stichting
- Department Name
- Internal Medicine / Oncology
- Principal Investigator Name
- Aart Beeker
- Principal Investigator Email
- abeeker@spaarnegastuis.nl
- Contact Person Name
- Aart Beeker
- Contact Person Email
- abeeker@spaarnegastuis.nl
- Site Name
- Haga Hospital
- Department Name
- Internal Medicine / Oncology
- Principal Investigator Name
- Daniel Houtsma
- Principal Investigator Email
- d.houtsma@hagaziekenhuis.nl
- Contact Person Name
- Daniel Houtsma
- Contact Person Email
- d.houtsma@hagaziekenhuis.nl
Greece
- Earliest CTIS Part Ii Submission Date
- 01-08-2024
- Latest Decision Or Authorization Date
- 15-04-2025
- Processing Time Days
- 258
- Number Of Sites
- 6
- Number Of Participants
- 35
Sites
- Site Name
- University General Hospital Attikon
- Department Name
- 2nd Propaedeutic Internal Medicine Clinic
- Principal Investigator Name
- Aristotelis Bamias
- Principal Investigator Email
- abamias@med.uoa.gr
- Contact Person Name
- Aristotelis Bamias
- Contact Person Email
- abamias@med.uoa.gr
- Site Name
- St. Savas Hospital
- Department Name
- Urology Clinic
- Principal Investigator Name
- Theodore Anagnostou
- Principal Investigator Email
- theodoreanagnostou@gmail.com
- Contact Person Name
- Theodore Anagnostou
- Contact Person Email
- theodoreanagnostou@gmail.com
- Site Name
- Metropolitan Hospital
- Department Name
- 2nd Oncology Clinic
- Principal Investigator Name
- Epaminondas Samantas
- Principal Investigator Email
- epsam@otenet.gr
- Contact Person Name
- Epaminondas Samantas
- Contact Person Email
- epsam@otenet.gr
- Site Name
- Hygeia Hospital- Hygeia Diagnostic & Therapeutic Center of Athens
- Department Name
- 3rd Medical Oncology Department
- Principal Investigator Name
- Georgios Rigakos
- Principal Investigator Email
- grigakos@oncologists.gr
- Contact Person Name
- Georgios Rigakos
- Contact Person Email
- grigakos@oncologists.gr
- Site Name
- Metropolitan General Hospital
- Department Name
- Oncology Clinical Trials and Research Clinic
- Principal Investigator Name
- Evangelos Bournakis
- Principal Investigator Email
- vagimith@yahoo.com
- Contact Person Name
- Evangelos Bournakis
- Contact Person Email
- vagimith@yahoo.com
- Site Name
- General University Hospital Of Patras
- Department Name
- Oncology Department of Internal Medicine Clinic
- Principal Investigator Name
- Angelos Koutras
- Principal Investigator Email
- angkoutr@otenet.gr
- Contact Person Name
- Angelos Koutras
- Contact Person Email
- angkoutr@otenet.gr
Czechia
- Earliest CTIS Part Ii Submission Date
- 01-08-2024
- Latest Decision Or Authorization Date
- 14-04-2025
- Processing Time Days
- 257
- Number Of Sites
- 6
- Number Of Participants
- 45
Sites
- Site Name
- Multiscan s.r.o.
- Department Name
- Oncology and radiology clinic
- Principal Investigator Name
- Karel Odrážka
- Principal Investigator Email
- odrazka@seznam.cz
- Contact Person Name
- Karel Odrážka
- Contact Person Email
- odrazka@seznam.cz
- Site Name
- Fakultni Thomayerova nemocnice
- Department Name
- Oncology clinic
- Principal Investigator Name
- Eugen Kubala
- Principal Investigator Email
- eugen.kubala@ftn.cz
- Contact Person Name
- Eugen Kubala
- Contact Person Email
- eugen.kubala@ftn.cz
- Site Name
- Fakultni Nemocnice V Motole
- Department Name
- Oncology clinic
- Principal Investigator Name
- Tomás Büchler
- Principal Investigator Email
- tomas.buchelr@fnmotol.cz
- Contact Person Name
- Tomás Büchler
- Contact Person Email
- tomas.buchelr@fnmotol.cz
- Site Name
- Fakultni Nemocnice Hradec Kralove
- Department Name
- Radiology and oncology clinic
- Principal Investigator Name
- Miroslav Hodek
- Principal Investigator Email
- miroslav.hodek@fnhk.cz
- Contact Person Name
- Miroslav Hodek
- Contact Person Email
- miroslav.hodek@fnhk.cz
- Site Name
- Fakultni Nemocnice Kralovske Vinohrady
- Department Name
- Radiology and oncology clinic
- Principal Investigator Name
- Jan Dvořák
- Principal Investigator Email
- jan.dvorak@fnkv.cz
- Contact Person Name
- Jan Dvořák
- Contact Person Email
- jan.dvorak@fnkv.cz
- Site Name
- Multiscan s.r.o. (Horovice)
- Department Name
- Oncology clinic
- Principal Investigator Name
- Martin Šmakal
- Principal Investigator Email
- msmakal@gmail.com
- Contact Person Name
- Martin Šmakal
- Contact Person Email
- msmakal@gmail.com
Spain
- Earliest CTIS Part Ii Submission Date
- 01-08-2024
- Latest Decision Or Authorization Date
- 15-04-2025
- Processing Time Days
- 258
- Number Of Sites
- 11
- Number Of Participants
- 121
Sites
- Site Name
- Hospital Universitario Ramon Y Cajal
- Department Name
- Oncology
- Principal Investigator Name
- Teresa Alonso Gordoa
- Principal Investigator Email
- talonso@oncologiahrc.com
- Contact Person Name
- Teresa Alonso Gordoa
- Contact Person Email
- talonso@oncologiahrc.com
- Site Name
- Hospital Universitario Lucus Augusti
- Department Name
- Oncology
- Principal Investigator Name
- Sergio Vazquez Estevez
- Principal Investigator Email
- sergio.vazquez.estevez@sergas.es
- Contact Person Name
- Sergio Vazquez Estevez
- Contact Person Email
- sergio.vazquez.estevez@sergas.es
- Site Name
- Hospital Clinic De Barcelona
- Department Name
- Oncology
- Principal Investigator Name
- Begoña Mellado Gonzalez
- Principal Investigator Email
- bmellado@clinic.cat
- Contact Person Name
- Begoña Mellado Gonzalez
- Contact Person Email
- bmellado@clinic.cat
- Site Name
- Hospital Quironsalud Sagrado Corazon
- Department Name
- Oncology
- Principal Investigator Name
- Juan Antonio Virizuela Echaburu
- Principal Investigator Email
- javirizuelae@seom.org
- Contact Person Name
- Juan Antonio Virizuela Echaburu
- Contact Person Email
- javirizuelae@seom.org
- Site Name
- Hospital Universitario Virgen De La Victoria
- Department Name
- Oncology
- Principal Investigator Name
- Lucia Oliva Fernandez
- Principal Investigator Email
- luciaolifer3@gmail.com
- Contact Person Name
- Lucia Oliva Fernandez
- Contact Person Email
- luciaolifer3@gmail.com
- Site Name
- Hospital Del Mar
- Department Name
- Oncology
- Principal Investigator Name
- Alejo Rodriguez Vida
- Principal Investigator Email
- arodriguezvida@parcdesalutmar.cat
- Contact Person Name
- Alejo Rodriguez Vida
- Contact Person Email
- arodriguezvida@parcdesalutmar.cat
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Oncology
- Principal Investigator Name
- Joan Carles Galceran
- Principal Investigator Email
- jcarles@vhio.net
- Contact Person Name
- Joan Carles Galceran
- Contact Person Email
- jcarles@vhio.net
- Site Name
- Hospital De La Santa Creu I Sant Pau
- Department Name
- Oncology
- Principal Investigator Name
- Jose Maroto Rey
- Principal Investigator Email
- jmaroto@santpau.cat
- Contact Person Name
- Jose Maroto Rey
- Contact Person Email
- jmaroto@santpau.cat
- Site Name
- Hospital Universitario Reina Sofia
- Department Name
- Oncology
- Principal Investigator Name
- Maria Jose Mendez Vidal
- Principal Investigator Email
- mjosemv@yahoo.es
- Contact Person Name
- Maria Jose Mendez Vidal
- Contact Person Email
- mjosemv@yahoo.es
- Site Name
- Parc Tauli Hospital Universitari
- Department Name
- Oncology
- Principal Investigator Name
- Enrique Gallardo Diaz
- Principal Investigator Email
- egallardo@tauli.cat
- Contact Person Name
- Enrique Gallardo Diaz
- Contact Person Email
- egallardo@tauli.cat
- Site Name
- Hospital Clinico San Carlos
- Department Name
- Oncology
- Principal Investigator Name
- Javier Puente Vazquez
- Principal Investigator Email
- javierpuente.hcsc@gmail.com
- Contact Person Name
- Javier Puente Vazquez
- Contact Person Email
- javierpuente.hcsc@gmail.com
Poland
- Earliest CTIS Part Ii Submission Date
- 01-08-2024
- Latest Decision Or Authorization Date
- 15-04-2025
- Processing Time Days
- 258
- Number Of Sites
- 5
- Number Of Participants
- 32
Sites
- Site Name
- Szpital Wojewodzki Im. Mikolaja Kopernika W Koszalinie
- Department Name
- Klinika Chemioterapii z oddziałem dziennym
- Principal Investigator Name
- Mariusz Kwiatkowski
- Principal Investigator Email
- mariusz.kwiatkowski@swk.med.pl
- Contact Person Name
- Mariusz Kwiatkowski
- Contact Person Email
- mariusz.kwiatkowski@swk.med.pl
- Site Name
- Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
- Department Name
- Klinika Nowotworów Układu Moczowego
- Principal Investigator Name
- Paweł Wiechno
- Principal Investigator Email
- wiechno@gmail.com
- Contact Person Name
- Paweł Wiechno
- Contact Person Email
- wiechno@gmail.com
- Site Name
- Mazowiecki Szpital Onkologiczny Sp. z o.o.
- Department Name
- Poradnia Onkologiczna
- Principal Investigator Name
- Sylwina Socha
- Principal Investigator Email
- s.socha@szpitalonkologiczny.pl
- Contact Person Name
- Sylwina Socha
- Contact Person Email
- s.socha@szpitalonkologiczny.pl
- Site Name
- Wojewodzkie Wielospecjalistyczne Centrum Onkologii I Traumatologii Im M.Kopernika W Lodzi
- Department Name
- Oddział Chorób Rozrostowych
- Principal Investigator Name
- Magdalena Ciązyńska
- Principal Investigator Email
- ciazynska.magdalena@gmail.com
- Contact Person Name
- Magdalena Ciązyńska
- Contact Person Email
- ciazynska.magdalena@gmail.com
- Site Name
- Opolskie Centrum Onkologii Im. Prof. Tadeusza Koszarowskiego W Opolu Samodzielny Publiczny Zaklad Opieki Zdrowotnej
- Department Name
- Klinika Onkologii z oddziałem dziennym
- Principal Investigator Name
- Barbara Radecka
- Principal Investigator Email
- brad@onkologia.opole.pl
- Contact Person Name
- Barbara Radecka
- Contact Person Email
- brad@onkologia.opole.pl
Belgium
- Earliest CTIS Part Ii Submission Date
- 01-08-2024
- Latest Decision Or Authorization Date
- 14-04-2025
- Processing Time Days
- 257
- Number Of Sites
- 4
- Number Of Participants
- 22
Sites
- Site Name
- Centre hospitalier universitaire de Liege
- Department Name
- Medical Oncology
- Principal Investigator Name
- Brieuc Sautois
- Principal Investigator Email
- brieuc.sautois@chuliege.be
- Contact Person Name
- Brieuc Sautois
- Contact Person Email
- brieuc.sautois@chuliege.be
- Site Name
- Algemeen Ziekenhuis Klina
- Department Name
- Medical Oncology
- Principal Investigator Name
- Wim Demey
- Principal Investigator Email
- wim.demey@klina.be
- Contact Person Name
- Wim Demey
- Contact Person Email
- wim.demey@klina.be
- Site Name
- Az Maria Middelares Gent
- Department Name
- Medical Oncology
- Principal Investigator Name
- Christof Vulsteke
- Principal Investigator Email
- christof.vulsteke@azmmsj.be
- Contact Person Name
- Christof Vulsteke
- Contact Person Email
- christof.vulsteke@azmmsj.be
- Site Name
- Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur
- Department Name
- Medical Oncology
- Principal Investigator Name
- Lionel D'Hondt
- Principal Investigator Email
- lionel.dhondt@uclouvain.be
- Contact Person Name
- Lionel D'Hondt
- Contact Person Email
- lionel.dhondt@uclouvain.be
Hungary
- Earliest CTIS Part Ii Submission Date
- 01-08-2024
- Latest Decision Or Authorization Date
- 09-07-2025
- Processing Time Days
- 343
- Number Of Sites
- 8
- Number Of Participants
- 43
Sites
- Site Name
- Semmelweis University
- Department Name
- Urology
- Principal Investigator Name
- Péter Nyirády
- Principal Investigator Email
- titkarsag.urologia@med.semmelweis-univ.hu
- Contact Person Name
- Péter Nyirády
- Contact Person Email
- titkarsag.urologia@med.semmelweis-univ.hu
- Site Name
- Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz
- Department Name
- Oncoradiology
- Principal Investigator Name
- Ágnes Wéber
- Principal Investigator Email
- agneswebermd@gmail.com
- Contact Person Name
- Ágnes Wéber
- Contact Person Email
- agneswebermd@gmail.com
- Site Name
- Orszagos Onkologiai Intezet
- Department Name
- Chemotherapy and Clinical Pharmacology Department
- Principal Investigator Name
- Lajos Géczi
- Principal Investigator Email
- gelajos@oncol.hu
- Contact Person Name
- Lajos Géczi
- Contact Person Email
- gelajos@oncol.hu
- Site Name
- Bacs-Kiskun Varmegyei Oktatokorhaz
- Department Name
- Oncoradiology
- Principal Investigator Name
- Judit Kocsis
- Principal Investigator Email
- kocsisjucidr@gmail.com
- Contact Person Name
- Judit Kocsis
- Contact Person Email
- kocsisjucidr@gmail.com
- Site Name
- Jasz-Nagykun-Szolnok Varmegyei Hetenyi Geza Korhaz-Rendelointezet
- Department Name
- Oncology
- Principal Investigator Name
- Anikó Ragályi
- Principal Investigator Email
- szolnok.onkologia@gmail.com
- Contact Person Name
- Anikó Ragályi
- Contact Person Email
- szolnok.onkologia@gmail.com
- Site Name
- Budapesti Uzsoki Utcai Korhaz
- Department Name
- Oncoradiology
- Principal Investigator Name
- Róbert Farkas
- Principal Investigator Email
- robert.farkas7222@gmail.com
- Contact Person Name
- Róbert Farkas
- Contact Person Email
- robert.farkas7222@gmail.com
- Site Name
- University Of Szeged
- Department Name
- Oncotherapy
- Principal Investigator Name
- Judit Oláh
- Principal Investigator Email
- lazarne.olah.judit@med.u-szeged.hu
- Contact Person Name
- Judit Oláh
- Contact Person Email
- lazarne.olah.judit@med.u-szeged.hu
- Site Name
- Del-Pesti Centrumkorhaz Orszagos Hematologiai Es Infektologiai Intezet
- Department Name
- Oncology
- Principal Investigator Name
- György Bodoky
- Principal Investigator Email
- bodokygy@hungarnet.hu
- Contact Person Name
- György Bodoky
- Contact Person Email
- bodokygy@hungarnet.hu
Sponsor
Primary sponsor
- Full Name
- AstraZeneca AB
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Sweden
Contract research organisations
- Name
- Fortrea Inc.
- Responsibilities
- Provision of multiple sponsor functions including 24-hour emergency medical cover service, ePRO, eCOA, patient reimbursement, patient and site aid, recruitment and engagement material, medical image analysis, and other operational duties (see sponsor duties list). Contact: submissions@fortrea.com
- Name
- Fortrea Development Ltd. Branch Of Foreign Company
- Responsibilities
- Contract negotiation and execution with clinical trial sites and investigators, processing related payments and operational site support. Contact: Submissions@Fortrea.com
Third parties
- {"country":"United States","full_name":"Fortrea Inc.","duties_or_roles":"Sponsor duties codes present including: code 1, 10, 11, 12, 13 and code 15 duties including '24-hour emergency medical cover service, ePRO (Electonic patient reported outcomes), eCOA (Electronic Clinical Outcome Assessment), Patient Reimbursement, patient and site aid, recruitment and engagement material' and 'Medical image analysis'. Contact email: submissions@fortrea.com","organisation_type":"Pharmaceutical company"}
- {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"Distribution of samples to the adequate external central labs for Immunohistochemistry (IHC) testing, Next generation sequencing, Pharmacokinetics (PK) testing, Archival of optional genetic samples until the end of the study; other duties (code 4). Contact email: ctasubmissions@labcorp.com","organisation_type":"Pharmaceutical company"}
- {"country":"Greece","full_name":"Fortrea Development Ltd. Branch Of Foreign Company","duties_or_roles":"Negotiation and execution and signature of contracts with clinical trial sites, investigators and processing of the related payments; other duties (codes 1,12,2,8). Contact email: Submissions@Fortrea.com","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- Capivasertib
- Active Substance
- CAPIVASERTIB
- Modality
- Small molecule
- Routes Of Administration
- ORAL USE
- Route
- oral
- Authorisation Status
- prodAuthStatus:1
- Maximum Dose
- 400 mg
- Investigational Product Name
- Docetaxel (Docetaxel formulations listed: Docetaxel Accord; Docetaxel Hikma; Bendadocel 20 mg/ml)
- Active Substance
- DOCETAXEL
- Modality
- Small molecule
- Routes Of Administration
- INTRAVENOUS USE
- Route
- intravenous
- Authorisation Status
- prodAuthStatus:2 (for authorised marketed docetaxel products listed)
- Maximum Dose
- 75 mg/m2
- Investigational Product Name
- Placebo to capivasertib
- Modality
- Other
- Combination Treatment
- Yes
Related trials
Other published trials that may interest you.
- TD001 for Metastatic castration-resistant prostate cancer
- TESTOSTERONE for Metastatic castration-resistant prostate cancer
- JNJ-78278343 for Metastatic castration-resistant prostate cancer
- ENZALUTAMIDE for Metastatic castration-resistant prostate cancer
- Ebastine for Metastatic castration-resistant prostate cancer