Clinical trial • Phase III • Oncology
CABAZITAXEL for Prostate cancer | Localized high-risk prostate cancer
Phase III trial of CABAZITAXEL for Prostate cancer | Localized high-risk prostate cancer. Randomised. 760 participants.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Prostate cancer | Localized high-risk prostate cancer
- Trial Stage
- Phase III
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 03-10-2024
- First CTIS Authorization Date
- 04-11-2024
Trial design
Randomised Phase III trial across 61 sites in Belgium, France, Spain.
- Randomised
- Yes
- Target Sample Size
- 760
- Trial Duration For Participant
- 3650
Eligibility
Recruits 760 Individuals deprived of liberty or placed under the authority of a tutor are explicitly excluded. Participants must have received the information sheet and signed the informed consent form. Trial enrolment is limited to adults (18–75 years); no assent provisions for minors are indicated..
- Vulnerable Population
- Individuals deprived of liberty or placed under the authority of a tutor are explicitly excluded. Participants must have received the information sheet and signed the informed consent form. Trial enrolment is limited to adults (18–75 years); no assent provisions for minors are indicated.
Inclusion criteria
- {"criterion_text":"- Any T histologically confirmed adenocarcinoma of the prostate\n- Platelets ≥ 100 x 10^9/L\n- Hb≥ 9.0 g/dL\n- Hepatic function: serum bilirubin ≤ 1 ULN (except in case of Gilbert's syndrome) ; AST and ALT ≤ 2.5 x ULN\n- Renal function (creatinine clearance using the CKD-EPI formula (Chronic Kidney Disease Epidemiology group, see Appendix 4) ≥ 60 mL/min).\n- Potentially reproductive patients must agree to use an effective contraceptive method while on treatment and for 6 months after the final dose of investigational product.\n- Patient must be affiliated to a Social Security System or should fulfill the country legislation for clinical trials.\n- Patient who have received the information sheet and signed the informed consent form.\n- Patient must be willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures\n- No clinically or radiologically suspected metastases, including no enlarged pelvic lymph nodes (> 1 cm in small diameter)\n- Gleason score ≥ 6\n- Meets at least 2 of the following criteria for high-risk: - Gleason score ≥ 8 - T3 or T4 disease (T3 defined by MRI is acceptable) - Prostate-specific antigen equal or greater than 20 ng/mL\n- No prior treatment for prostate cancer except lymph node dissection (patients with pN- and pN+ disease can be accrued) or ADT (started up to 6 weeks before randomization).\n- 18 years ≤ Age≤ 75 years\n- ECOG 0-1 performance status\n- Expected life expectancy of more than 10 years\n- Absolute neutrophil count ≥ 1.5 x 10^9/L"}
Exclusion criteria
- {"criterion_text":"- Patient with other known concurrent severe and/or uncontrolled medical disease which could compromise participation in the study, such as: a- infection, b- cardiac disease such as uncontrolled hypertension, congestive cardiac failure, ventricular arrhythmias, active ischemic heart disease, myocardial infarction within one year, LVEF > grade 2, c- uncontrolled diabetes mellitus, d- current active hepatic or biliary disease (with exception of subjects with Gilbert's syndrome, asymptomatic gallstones, stable chronic liver disease per investigator assessment), e- renal disease, f- active GI tract ulceration, malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel. Subjects with active, uncontrolled ulcerative colitis are also excluded, g- known severely impaired lung function (spirometry and DLCO 70% or less of normal and O2 saturation of 88% or less at rest on room air).\n- Individual deprived of liberty or placed under the authority of a tutor.\n- Concomitant prohibited treatment. Concurrent or planned treatment with strong inhibitors or strong inducers of cytochrome P450 3A4/5. A one week wash-out period is necessary for patients who are already on these treatments.\n- Other prior malignancy within the last 5 years, except basal cell skin cancer\n- Physical or psychological condition that would preclude study compliance\n- Hypersensitivity to cabazitaxel (hypersensitivity reaction ≥grade 3), to other taxanes, or to any excipients of the formulation including polysorbate 80\n- Patient with significantly altered mental status prohibiting the understanding of the study or with psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial.\n- Patient who received any other investigational drugs within the 30 days prior to the start of cabazitaxel.\n- Previous pelvic irradiation that make prostatic irradiation impossible\n- Severe GI disorders precluding pelvic irradiation\n- Patient already included in another therapeutic trial involving an experimental drug"}
Endpoints
Primary endpoints
- {"endpoint_text":"- La supervivencia específica del cáncer de próstata se calculará entre la fecha de aleatorización y la fecha de la muerte por el cáncer de próstata.","definition_or_measurement_approach":"Prostate cancer-specific survival calculated from date of randomization to date of death due to prostate cancer. (Also described in translations as clinical progression-free survival/cPFS with events including metastatic relapse, proven local progression [biopsy or imaging] and death [all-cause].)"}
Secondary endpoints
- {"endpoint_text":"- The prostate-specific antigen response at 3 months will be defined as a serum PSA value (≤ 0.2 ng/mL)","definition_or_measurement_approach":"Defined as serum PSA ≤ 0.2 ng/mL at 3 months."}
- {"endpoint_text":"- The biochemical progression-free survival is defined as the time from randomization to the date of PSA relapse (evaluated according to Phoenix criteria i.e. nadir + 2 ng/mL) or death.","definition_or_measurement_approach":"Time from randomization to PSA relapse per Phoenix criteria (nadir + 2 ng/mL) or death."}
- {"endpoint_text":"- The metastases-free survival is defined as the time from randomization to the date of the appearance of the metastases on imaging (mainly bone scan and CT-scan) or death.","definition_or_measurement_approach":"Time from randomization to radiological evidence of metastases (primarily bone scan and CT) or death."}
- {"endpoint_text":"- The local relapse-free survival is defined as the time from randomization to the date of the appearance of the first local relapse or death.","definition_or_measurement_approach":"Time from randomization to first local relapse or death."}
- {"endpoint_text":"- The overall survival will be calculated from the date of randomization to the date of death from any cause or date of the last follow-up.","definition_or_measurement_approach":"Time from randomization to death from any cause or last follow-up."}
- {"endpoint_text":"- The prostate cancer-specific survival will be calculated from the date of randomization to the date of the death due to prostate cancer","definition_or_measurement_approach":"Time from randomization to death due to prostate cancer."}
- {"endpoint_text":"- The acute toxicity (i.e. during the treatment period), will be evaluated according to the NCI-CTC v4.0 criteria","definition_or_measurement_approach":"Acute toxicity assessed during treatment using NCI-CTC v4.0 criteria."}
- {"endpoint_text":"- The impact of treatment on serum testosterone will be evaluated at baseline, 6 months then yearly.","definition_or_measurement_approach":"Serum testosterone measured at baseline, 6 months, then annually."}
- {"endpoint_text":"- The long-term toxicity (potency, cardiac, hot flashes and late toxicity related to radiotherapy or chemotherapy) will be evaluated at 1 year, 2 years and 5 years. The toxicity related to the radiotherapy will be assessed using NCI-CTC v4.0 criteria.","definition_or_measurement_approach":"Long-term toxicity (including radiotherapy-related) assessed at 1, 2 and 5 years using NCI-CTC v4.0 where applicable."}
- {"endpoint_text":"- The predictive biomarkers of treatment efficacy will be assessed on archival biopsy specimens","definition_or_measurement_approach":"Predictive biomarkers evaluated on archival biopsy specimens."}
- {"endpoint_text":"- The quality of life will be evaluated with the QLQ –C30 and PR25 questionnaires at baseline, 6 months then yearly up to 10 years after the randomization date.","definition_or_measurement_approach":"Quality of life measured with EORTC QLQ-C30 and PR25 questionnaires at baseline, 6 months, then annually up to 10 years."}
Recruitment
- Planned Sample Size
- 760
- Recruitment Window Months
- 331
- Consent Approach
- Participants must receive an information sheet and sign an informed consent form. Subject information and informed consent form documents are available for adults for Belgium (L1_SIS and ICF adults_BE), France (L1_SIS and ICF adults FR, including an RGPD addendum) and Spain (L1_SIS and ICF adults_SP). Consent is provided by the adult participant; no assent provisions for minors are indicated.
Geography
- Total Number Of Sites
- 61
- Total Number Of Participants
- 760
Belgium
- Earliest CTIS Part Ii Submission Date
- 02-09-2024
- Latest Decision Or Authorization Date
- 04-11-2024
- Processing Time Days
- 63
- Number Of Sites
- 3
- Number Of Participants
- 12
Sites
- Site Name
- Grand Hopital De Charleroi
- Department Name
- Hemato-oncology
- Principal Investigator Name
- Marco GIZZI
- Principal Investigator Email
- marco.gizzi@ghdc.be
- Contact Person Name
- Marco GIZZI
- Contact Person Email
- marco.gizzi@ghdc.be
- Site Name
- Cliniques Universitaires Saint-Luc
- Department Name
- Medical oncology
- Principal Investigator Name
- Bertrand TOMBAL
- Principal Investigator Email
- bertrand.tombal@uclouvain.be
- Contact Person Name
- Bertrand TOMBAL
- Contact Person Email
- bertrand.tombal@uclouvain.be
- Site Name
- CHC MontLegia
- Department Name
- Oncology
- Principal Investigator Name
- Geoffrey MATUS
- Principal Investigator Email
- geoffrey.matus@chc.be
- Contact Person Name
- Geoffrey MATUS
- Contact Person Email
- geoffrey.matus@chc.be
France
- Earliest CTIS Part Ii Submission Date
- 02-09-2024
- Latest Decision Or Authorization Date
- 13-12-2024
- Processing Time Days
- 102
- Number Of Sites
- 46
- Number Of Participants
- 596
Sites
- Site Name
- Centre azureen de cancerologie
- Department Name
- Radiotherapy
- Principal Investigator Name
- Philippe RONCHIN
- Principal Investigator Email
- ronchinp@yahoo.fr
- Contact Person Name
- Philippe RONCHIN
- Contact Person Email
- ronchinp@yahoo.fr
- Site Name
- Hopital Saint Louis
- Department Name
- Oncology
- Principal Investigator Name
- Stéphane CULINE
- Principal Investigator Email
- stephane.culine@aphp.fr
- Contact Person Name
- Stéphane CULINE
- Contact Person Email
- stephane.culine@aphp.fr
- Site Name
- Centre Leon Berard
- Department Name
- Oncology-Radiotherapy
- Principal Investigator Name
- Aude FLECHON
- Principal Investigator Email
- aude.flechon@lyon.unicancer.fr
- Contact Person Name
- Aude FLECHON
- Contact Person Email
- aude.flechon@lyon.unicancer.fr
- Site Name
- Institut De Cancerologie De L Ouest (Angers)
- Department Name
- Oncology
- Principal Investigator Name
- Sophie ABADIE-LACOURTOISIE
- Principal Investigator Email
- sophie.abadie-lacourtoisie@ico.unicancer.fr
- Contact Person Name
- Sophie ABADIE-LACOURTOISIE
- Contact Person Email
- sophie.abadie-lacourtoisie@ico.unicancer.fr
- Site Name
- Institut Bergonie
- Department Name
- Medical Oncology
- Principal Investigator Name
- Guihem ROUBAUD
- Principal Investigator Email
- g.roubaud@bordeaux.unicancer.fr
- Contact Person Name
- Guihem ROUBAUD
- Contact Person Email
- g.roubaud@bordeaux.unicancer.fr
- Site Name
- Institut De Cancerologie De L Ouest (Saint-Herblain Cedex)
- Department Name
- Medical Oncology
- Principal Investigator Name
- Emmanuelle BOMPAS
- Principal Investigator Email
- emmanuelle.bompas@ico.unicancer.fr
- Contact Person Name
- Emmanuelle BOMPAS
- Contact Person Email
- emmanuelle.bompas@ico.unicancer.fr
- Site Name
- Centre Hospitalier Departemental Vendee
- Department Name
- Hemato-oncology
- Principal Investigator Name
- Franck PRIOU
- Principal Investigator Email
- frank.priou@chd-vendee.fr
- Contact Person Name
- Franck PRIOU
- Contact Person Email
- frank.priou@chd-vendee.fr
- Site Name
- Institut Curie
- Department Name
- Medical Oncology
- Principal Investigator Name
- Zahra CASTEL-AJGAL
- Principal Investigator Email
- zahra.castelajgal@curie.fr
- Contact Person Name
- Zahra CASTEL-AJGAL
- Contact Person Email
- zahra.castelajgal@curie.fr
- Site Name
- Centre Hospitalier Universitaire De Saint Etienne
- Department Name
- Medical Oncology
- Principal Investigator Name
- Pierre CORNILLON
- Principal Investigator Email
- pierre.cornillon@chu-st-etienne.fr
- Contact Person Name
- Pierre CORNILLON
- Contact Person Email
- pierre.cornillon@chu-st-etienne.fr
- Site Name
- Institut Gustave Roussy
- Department Name
- Oncology
- Principal Investigator Name
- Karim FIZAZI
- Principal Investigator Email
- karim.fizazi@gustaveroussy.fr
- Contact Person Name
- Karim FIZAZI
- Contact Person Email
- karim.fizazi@gustaveroussy.fr
- Site Name
- CHP Sainte Marie Osny
- Department Name
- Radiotherapy
- Principal Investigator Name
- Antoine BRUNA
- Principal Investigator Email
- a.bruna@crom95.com
- Contact Person Name
- Antoine BRUNA
- Contact Person Email
- a.bruna@crom95.com
- Site Name
- Centre Hospitalier Regional Et Universitaire De Brest
- Department Name
- Radiotherapy
- Principal Investigator Name
- Ulrike SCHICK
- Principal Investigator Email
- ulrike.schick@chu-brest.fr
- Contact Person Name
- Ulrike SCHICK
- Contact Person Email
- ulrike.schick@chu-brest.fr
- Site Name
- Oncoradio Centre Oncogard
- Department Name
- Medical Oncology
- Principal Investigator Name
- Arnaud BOUTTE
- Principal Investigator Email
- boutte.oncogard@orange.fr
- Contact Person Name
- Arnaud BOUTTE
- Contact Person Email
- boutte.oncogard@orange.fr
- Site Name
- Centre Hospitalier Regional Universitaire De Tours
- Department Name
- Medical Oncology
- Principal Investigator Name
- Bérengère NARCISO RAHARIMANANA
- Principal Investigator Email
- berengere.narciso@univ-tours.fr
- Contact Person Name
- Bérengère NARCISO RAHARIMANANA
- Contact Person Email
- berengere.narciso@univ-tours.fr
- Site Name
- CARIO Centre Armoricain de Radiotherapie D'Imagerie medicale et D'Oncologie
- Department Name
- Medical Oncology
- Principal Investigator Name
- Dominique BESSON
- Principal Investigator Email
- d.besson@cario-sante.fr
- Contact Person Name
- Dominique BESSON
- Contact Person Email
- d.besson@cario-sante.fr
- Site Name
- Institut Paoli Calmettes
- Department Name
- Oncology
- Principal Investigator Name
- Gwenaëlle GRAVIS
- Principal Investigator Email
- gravisg@ipc.unicancer.fr
- Contact Person Name
- Gwenaëlle GRAVIS
- Contact Person Email
- gravisg@ipc.unicancer.fr
- Site Name
- Centre Francois Baclesse
- Department Name
- Oncology
- Principal Investigator Name
- Florence JOLY
- Principal Investigator Email
- f.joly@baclesse.fr
- Contact Person Name
- Florence JOLY
- Contact Person Email
- f.joly@baclesse.fr
- Site Name
- Hospices Civils De Lyon
- Department Name
- Urology
- Principal Investigator Name
- Denis MAILLET
- Principal Investigator Email
- denis.maillet@chu-lyon.fr
- Contact Person Name
- Denis MAILLET
- Contact Person Email
- denis.maillet@chu-lyon.fr
- Site Name
- Centre Hospitalier Universitaire De Poitiers
- Department Name
- Radiotherapy
- Principal Investigator Name
- Stéphane GUERIF
- Principal Investigator Email
- stephane.guerif@chu-poitiers.fr
- Contact Person Name
- Stéphane GUERIF
- Contact Person Email
- stephane.guerif@chu-poitiers.fr
- Site Name
- Clinique Ambroise Pare
- Department Name
- Radiotherapy
- Principal Investigator Name
- Mustapha FARES
- Principal Investigator Email
- afadin@radiopole-artois.com
- Contact Person Name
- Mustapha FARES
- Contact Person Email
- afadin@radiopole-artois.com
- Site Name
- Centre Hospitalier Metropole Savoie
- Department Name
- Medical Oncology
- Principal Investigator Name
- Philippe FOURNERET
- Principal Investigator Email
- philippe.fourneret@ch-metropole-savoie.fr
- Contact Person Name
- Philippe FOURNERET
- Contact Person Email
- philippe.fourneret@ch-metropole-savoie.fr
- Site Name
- Centre Hospitalier Prive Saint-Gregoire
- Department Name
- Radiotherapy
- Principal Investigator Name
- Xavier ARTIGNAN
- Principal Investigator Email
- xartignan@vivalto-sante.com
- Contact Person Name
- Xavier ARTIGNAN
- Contact Person Email
- xartignan@vivalto-sante.com
- Site Name
- GHBS Lorient
- Department Name
- Oncology
- Principal Investigator Name
- Guillaume BERA
- Principal Investigator Email
- g.bera@ch-bretagne-sud.fr
- Contact Person Name
- Guillaume BERA
- Contact Person Email
- g.bera@ch-bretagne-sud.fr
- Site Name
- Centre Jean Perrin
- Department Name
- Medical Oncology
- Principal Investigator Name
- Hakim MAHAMMEDI
- Principal Investigator Email
- hakim.mahammedi@clermont.unicancer.fr
- Contact Person Name
- Hakim MAHAMMEDI
- Contact Person Email
- hakim.mahammedi@clermont.unicancer.fr
- Site Name
- Oncopole Claudius Regaud
- Department Name
- Urology
- Principal Investigator Name
- Loïc MOUREY
- Principal Investigator Email
- mourey.loic@iuct-oncopole.fr
- Contact Person Name
- Loïc MOUREY
- Contact Person Email
- mourey.loic@iuct-oncopole.fr
- Site Name
- Institut Mutualiste Montsouris
- Department Name
- Oncology
- Principal Investigator Name
- Mostefa BENNAMOUN
- Principal Investigator Email
- mostefa.bennamoun@imm.fr
- Contact Person Name
- Mostefa BENNAMOUN
- Contact Person Email
- mostefa.bennamoun@imm.fr
- Site Name
- Centre Hospitalier Universitaire D Orleans
- Department Name
- Oncology-Radiotherapy
- Principal Investigator Name
- Elise CHAMPEAUX-ORANGE
- Principal Investigator Email
- elise.champeaux-orange@chr-orleans.fr
- Contact Person Name
- Elise CHAMPEAUX-ORANGE
- Contact Person Email
- elise.champeaux-orange@chr-orleans.fr
- Site Name
- Hopital Prive Clairval
- Department Name
- Oncology
- Principal Investigator Name
- Emmanuel GROSS
- Principal Investigator Email
- manugross@free.fr
- Contact Person Name
- Emmanuel GROSS
- Contact Person Email
- manugross@free.fr
- Site Name
- Centre Hospitalier Intercommunal De Cornouaille
- Department Name
- Medical Oncology
- Principal Investigator Name
- Friederike SCHLÜRMANN
- Principal Investigator Email
- friederike.schlurmann@chu-brest.fr
- Contact Person Name
- Friederike SCHLÜRMANN
- Contact Person Email
- friederike.schlurmann@chu-brest.fr
- Site Name
- Hopital Prive Toulon Hyeres Sainte Marguerite
- Department Name
- Oncology
- Principal Investigator Name
- Philippe BERNARD
- Principal Investigator Email
- philippe.bernard@dartybox.com
- Contact Person Name
- Philippe BERNARD
- Contact Person Email
- philippe.bernard@dartybox.com
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Oncology
- Principal Investigator Name
- Stéphane OUDARD
- Principal Investigator Email
- stephane.oudard@aphp.fr
- Contact Person Name
- Stéphane OUDARD
- Contact Person Email
- stephane.oudard@aphp.fr
- Site Name
- CHU Besancon
- Department Name
- Medical Oncology
- Principal Investigator Name
- Tristan MAURINA
- Principal Investigator Email
- t1maurina@chu-besancon.fr
- Contact Person Name
- Tristan MAURINA
- Contact Person Email
- t1maurina@chu-besancon.fr
- Site Name
- Centre Hospitalier Regional De Marseille
- Department Name
- Urology
- Principal Investigator Name
- Eric LECHEVALLIER
- Principal Investigator Email
- eric.lechevallier@ap-hm.fr
- Contact Person Name
- Eric LECHEVALLIER
- Contact Person Email
- eric.lechevallier@ap-hm.fr
- Site Name
- Centre Hospitalier Universitaire De Nimes
- Department Name
- Medical Oncology
- Principal Investigator Name
- Nadine HOUEDE
- Principal Investigator Email
- nadine.houede@chu-nimes.fr
- Contact Person Name
- Nadine HOUEDE
- Contact Person Email
- nadine.houede@chu-nimes.fr
- Site Name
- Clinique Pasteur Lanroze
- Department Name
- Radiotherapy
- Principal Investigator Name
- Ali HASBINI
- Principal Investigator Email
- alihasbini@oncologie-brest.fr
- Contact Person Name
- Ali HASBINI
- Contact Person Email
- alihasbini@oncologie-brest.fr
- Site Name
- Institut De Cancerologie De Lorraine
- Department Name
- Radiotherapy
- Principal Investigator Name
- Valérie BERNIER
- Principal Investigator Email
- v.bernier@nancy.unicancer.fr
- Contact Person Name
- Valérie BERNIER
- Contact Person Email
- v.bernier@nancy.unicancer.fr
- Site Name
- Centre De Lutte Contre Le Cancer Eugene Marquis
- Department Name
- Medical Oncology
- Principal Investigator Name
- Brigitte LAGUERRE
- Principal Investigator Email
- b.laguerre@rennes.unicancer.fr
- Contact Person Name
- Brigitte LAGUERRE
- Contact Person Email
- b.laguerre@rennes.unicancer.fr
- Site Name
- GIE Groupe hospitalier Paris Saint-Joseph/Vinci
- Department Name
- Oncology
- Principal Investigator Name
- Lionel STAUDACHER
- Principal Investigator Email
- lstaudacher@hpsj.fr
- Contact Person Name
- Lionel STAUDACHER
- Contact Person Email
- lstaudacher@hpsj.fr
- Site Name
- Clinique Generale
- Department Name
- Oncology-Radiotherapy
- Principal Investigator Name
- Anne DONEUX
- Principal Investigator Email
- adoneux@ch-annecygenevois.fr
- Contact Person Name
- Anne DONEUX
- Contact Person Email
- adoneux@ch-annecygenevois.fr
- Site Name
- Centre Hospitalier Regional De Marseille (second site)
- Department Name
- Oncology
- Principal Investigator Name
- Marjorie BACIUCHKA-PALMARO
- Principal Investigator Email
- marjorie.baciuchka@ap-hm.fr
- Contact Person Name
- Marjorie BACIUCHKA-PALMARO
- Contact Person Email
- marjorie.baciuchka@ap-hm.fr
- Site Name
- Hopital Tenon
- Department Name
- Oncology
- Principal Investigator Name
- Ahmed KHALIL
- Principal Investigator Email
- ahmed.khalil@aphp.fr
- Contact Person Name
- Ahmed KHALIL
- Contact Person Email
- ahmed.khalil@aphp.fr
- Site Name
- Unite De Recherche Clinique HIA Begin
- Department Name
- Medical Oncology
- Principal Investigator Name
- Carole HELISSEY
- Principal Investigator Email
- carole.helissey@gmail.com
- Contact Person Name
- Carole HELISSEY
- Contact Person Email
- carole.helissey@gmail.com
- Site Name
- Centre Hospitalier Et Universitaire De Limoges
- Department Name
- Radiotherapy
- Principal Investigator Name
- Pierre CLAVERE
- Principal Investigator Email
- pierre.clavere@chu-limoges.fr
- Contact Person Name
- Pierre CLAVERE
- Contact Person Email
- pierre.clavere@chu-limoges.fr
- Site Name
- Croix rouge Française Centre Radiothérapie Saint Louis
- Department Name
- Radiotherapy
- Principal Investigator Name
- Thomas DUBERGE
- Principal Investigator Email
- tduberge@yahoo.fr
- Contact Person Name
- Thomas DUBERGE
- Contact Person Email
- tduberge@yahoo.fr
- Site Name
- Clinique Pasteur (Toulouse)
- Department Name
- Oncology-Radiotherapy
- Principal Investigator Name
- Igor LATORZEFF
- Principal Investigator Email
- i.latorzeff@clinique-pasteur.com
- Contact Person Name
- Igor LATORZEFF
- Contact Person Email
- i.latorzeff@clinique-pasteur.com
- Site Name
- Centre de Radiothérapie - Clinique Sainte Anne
- Department Name
- Oncology
- Principal Investigator Name
- Youssef TAZI
- Principal Investigator Email
- y.tazi@solcrr.org
- Contact Person Name
- Youssef TAZI
- Contact Person Email
- y.tazi@solcrr.org
Spain
- Earliest CTIS Part Ii Submission Date
- 02-09-2024
- Latest Decision Or Authorization Date
- 19-11-2024
- Processing Time Days
- 78
- Number Of Sites
- 12
- Number Of Participants
- 152
Sites
- Site Name
- Hospital Universitario Virgen De La Victoria
- Department Name
- Oncology
- Principal Investigator Name
- Maria SAEZ
- Principal Investigator Email
- msaez.med@gmail.com
- Contact Person Name
- Maria SAEZ
- Contact Person Email
- msaez.med@gmail.com
- Site Name
- Althaia Xarxa Assistencial Universitaria De Manresa Fundacio Privada
- Department Name
- Oncology
- Principal Investigator Name
- Montserrat DOMENECH
- Principal Investigator Email
- mdomenech@althaia.cat
- Contact Person Name
- Montserrat DOMENECH
- Contact Person Email
- mdomenech@althaia.cat
- 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 Universitario Lucus Augusti
- Department Name
- Oncology
- Principal Investigator Name
- Sergio VAZQUEZ ESTEVEZ
- Principal Investigator Email
- sergio.vazquez.estevez@sergas.es
- Contact Person Name
- Maria SAEZ
- Contact Person Email
- msaez.med@gmail.com
- Site Name
- Parc Tauli Hospital Universitari
- Department Name
- Oncology
- Principal Investigator Name
- Enrique GALLARDO
- Principal Investigator Email
- egallardo@tauli.cat
- Contact Person Name
- Enrique GALLARDO
- Contact Person Email
- egallardo@tauli.cat
- Site Name
- Hospital Universitario De Salamanca
- Department Name
- Urology
- Principal Investigator Name
- Manuel HERRERO
- Principal Investigator Email
- mherreropolo@gmail.com
- Contact Person Name
- Manuel HERRERO
- Contact Person Email
- mherreropolo@gmail.com
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Oncology
- Principal Investigator Name
- Joan CARLES
- Principal Investigator Email
- jcarles@vhio.net
- Contact Person Name
- Joan CARLES
- Contact Person Email
- jcarles@vhio.net
- Site Name
- Hospital Universitario Reina Sofia
- Department Name
- Medical Oncology
- Principal Investigator Name
- Maria José MENDEZ VIDAL
- Principal Investigator Email
- mjosemv@yahoo.es
- Contact Person Name
- Maria José MENDEZ VIDAL
- Contact Person Email
- mjosemv@yahoo.es
- 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
- Consorci Sanitari De Terrassa
- Department Name
- Oncology
- Principal Investigator Name
- Maria MARIN ALCALA
- Principal Investigator Email
- mmarin@cst.cat
- Contact Person Name
- Maria MARIN ALCALA
- Contact Person Email
- mmarin@cst.cat
- Site Name
- Hospital Germans Trias I Pujol
- Department Name
- Radiotherapy
- Principal Investigator Name
- Salvador VILLA i FREIXA
- Principal Investigator Email
- svilla@iconcologia.net
- Contact Person Name
- Salvador VILLA i FREIXA
- Contact Person Email
- svilla@iconcologia.net
- Site Name
- Hospital Universitari Mutua Terrassa
- Department Name
- Oncology
- Principal Investigator Name
- Roma BASTUS
- Principal Investigator Email
- rbastus@mutuaterrassa.es
- Contact Person Name
- Roma BASTUS
- Contact Person Email
- rbastus@mutuaterrassa.es
Sponsor
Primary sponsor
- Full Name
- Unicancer
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- France
Third parties
- {"country":"","full_name":"Sanofi","duties_or_roles":"Monetary support","organisation_type":""}
Investigational products
- Investigational Product Name
- JEVTANA 60 mg concentrate and solvent for solution for infusion.
- Active Substance
- CABAZITAXEL
- Modality
- Small molecule
- Routes Of Administration
- Intravenous use
- Route
- Intravenous
- Authorisation Status
- Authorised (marketing authorisation EU/1/11/676/001)
- Maximum Dose
- 95 mg/m2
- Combination Treatment
- Yes
Related trials
Other published trials that may interest you.
- Enzalutamide for Prostate cancer | Localized high-risk prostate cancer
- GDC-9545 for Locally advanced or metastatic estrogen receptor-positive breast cancer
- Abemaciclib for Stage IV lung cancer | Breast cancer
- BGB-43395 for Advanced or metastatic solid tumors | Hormone receptor positive HER2 negative breast cancer
- AZD9833 for Estrogen receptor-positive HER2-negative advanced breast cancer