Drugs / Cabazitaxel
last change Jun 2026 re-read 2 minutes ago

Cabazitaxel

Other / unclassified

Developed for
prostate cancer · metastatic prostate carcinoma · castration-resistant prostate carcinoma · cancer · prostate carcinoma · breast cancer · prostate adenocarcinoma · urothelial carcinoma
+35 more · gastric cancer · metastatic malignant neoplasm in the brain · non-small cell lung carcinoma · prostate neoplasm · head and neck squamous cell carcinoma · hormone-resistant prostate carcinoma · ovarian cancer · prostate small cell carcinoma · acute leukemia of ambiguous lineage · acute lymphoblastic leukemia · adrenal cortex carcinoma · brain cancer · colorectal cancer · dedifferentiated liposarcoma · esophageal adenocarcinoma · esophageal disorder · gastric adenocarcinoma · gastroesophageal adenocarcinoma · gastroesophageal cancer · glioblastoma · head and neck cancer · Her2-receptor negative breast cancer · infiltrating bladder urothelial carcinoma · lung cancer · metastatic malignant neoplasm · neoplasm · neoplastic disease or syndrome · nervous system cancer · nongerminomatous germ cell tumor · penile carcinoma · prostate cancer aggressiveness quantitative trait locus on chromosome 19 · prostate neuroendocrine neoplasm · small cell lung carcinoma · testicular cancer · transitional cell carcinoma
Investigated by
Sanofi · M.D. Anderson Cancer Center · National Cancer Institute (NCI) · UNICANCER · University Hospitals Bristol and Weston NHS Foundation Trust · AstraZeneca
+90 more · Bristol-Myers Squibb · Case Comprehensive Cancer Center · Erasmus Medical Center · Gustave Roussy, Cancer Campus, Grand Paris · Hellenic Cooperative Oncology Group · Icahn School of Medicine at Mount Sinai · Merck Sharp & Dohme LLC · Novartis · OHSU Knight Cancer Institute · Oregon Health and Science University · SCRI Development Innovations, LLC · Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University · University of Alabama at Birmingham · Vejle Hospital · Weill Medical College of Cornell University · AIO-Studien-gGmbH · Alliance for Clinical Trials in Oncology · Andrew J. Armstrong, MD · Associació per a la Recerca Oncologica, Spain · Association Pour La Recherche des Thérapeutiques Innovantes en Cancérologie · Astellas Pharma Inc · Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia · Bayer · British Columbia Cancer Agency · Brown University · ClinAssess · Cliniques universitaires Saint-Luc- Université Catholique de Louvain · Consorzio Oncotech · Dr Anjali Zarkar · ECOG-ACRIN Cancer Research Group · European Organisation for Research and Treatment of Cancer - EORTC · Fudan University · Fundacion Oncosur · Fundación Ramón Domínguez · GBG Forschungs GmbH · Genzyme, a Sanofi Company · GlaxoSmithKline · Guarionex J. Decastro · H. Lee Moffitt Cancer Center and Research Institute · Hellenic Oncology Research Group · Helsinki University Central Hospital · Hospital Clinico Universitario de Santiago · Howard Safran · Institut Bergonié · Institut du Cancer de Montpellier - Val d'Aurelle · Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest · Janssen Pharmaceutica · Janssen Research & Development, LLC · Janssen Services, LLC · Jeffrey Yachnin M.D., PhD. · Jina Pharmaceuticals Inc. · Jules Bordet Institute · Krzysztof Misiukiewicz · Kuopio University Hospital · Masonic Cancer Center, University of Minnesota · Medical University of South Carolina · Memorial Sloan Kettering Cancer Center · Merrimack Pharmaceuticals · National Cancer Institute, France · Nova Scotia Cancer Centre · Orion Corporation, Orion Pharma · Ozmosis Research Inc. · Parexel · Peregrine Pharmaceuticals · Peter MacCallum Cancer Centre, Australia · Qilu Hospital of Shandong University · RWTH Aachen University · Rahul Aggarwal · Rambam Health Care Campus · Rhode Island Hospital · Roger Williams Medical Center · San Luigi Gonzaga Hospital · Seinajoki Central Hospital · Shanghai Jiao Tong University School of Medicine · all 96 on the full record

Regulatory milestones approvals, filings & regulatory actions · 6 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Label expansions (3) US (FDA) JEVTANA KIT 2017-05-17 – 2020-12-18 fda.gov
Refused (EMA) EU (EMA) Cabazitaxel Teva 2019-07-11 europa.eu
Approved EU (EMA) Jevtana 2011-03-17 europa.eu
Approved US (FDA) JEVTANA KIT 2010-06-17 fda.gov

Trials 103 · started per year

today
US approved 2010
EU approved 2011
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19992000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 114 trials
Phase 1 NCT05818683 Apr 2023 → Aug 2027 expected prostate carcinoma Janssen Research & Development, LLC Recruiting No outcome recorded
Phase 1 NCT03878524 Apr → Dec 2020 acute myeloid leukemia, atypical chronic myeloid leukemia, BCR-ABL1 negative, blast phase chronic myelogenous leukemia, BCR-ABL1 positive, castration-resistant prostate carcinoma +14 OHSU Knight Cancer Institute Terminated No outcome recorded
Phase 1 NCT03110588 May 2018 → Dec 2019 metastatic prostate carcinoma University of Alabama at Birmingham Withdrawn No outcome recorded
Phase 1 NCT01594918 Jun 2012 → Aug 2016 prostate carcinoma Rahul Aggarwal Completed No outcome recorded
Phase 1 NCT01527929 Apr 2012 → Nov 2013 cancer Sanofi Completed No outcome recorded
Phase 1 NCT01447225 Oct 2011 → Nov 2013 cancer Merrimack Pharmaceuticals Completed No outcome recorded
Phase 1 NCT01420250 Sep 2011 → Jul 2015 prostate cancer Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University Completed No outcome recorded
Phase 1 NCT01379339 Apr 2011 → Jan 2015 head and neck squamous cell carcinoma Krzysztof Misiukiewicz Completed No outcome recorded
Phase 1 NCT01324583 Jan 2011 → Nov 2014 prostate cancer Sanofi Completed No outcome recorded
Phase 1 NCT01140607 May 2010 → Jul 2014 cancer Sanofi Completed No outcome recorded
Phase 1/211 trials
Phase 1/2 NCT06353386 May 2024 → Jan 2029 expected castration-resistant prostate carcinoma Merck Sharp & Dohme LLC Recruiting No outcome recorded
Phase 1/2 NCT05340374 Jul 2022 → Jun 2026 overdue castration-resistant prostate carcinoma Peter MacCallum Cancer Centre, Australia Active not recruiting No outcome recorded
Phase 1/2 NCT02522715 Aug 2015 → Oct 2019 overdue castration-resistant prostate carcinoma, metastatic prostate carcinoma OHSU Knight Cancer Institute Active not recruiting No outcome recorded
Phase 1/2 NCT02202772 Dec 2014 → Apr 2026 overdue urothelial carcinoma Guarionex J. Decastro Active not recruiting No outcome recorded
Phase 1/2 NCT01740570 Apr 2013 → Apr 2017 brain cancer M.D. Anderson Cancer Center Withdrawn No outcome recorded
Phase 1/2 NCT01751308 Feb 2013 → Jul 2015 nervous system cancer Sanofi Completed No outcome recorded
Phase 1/2 NCT01505868 Jul 2012 → Dec 2019 castration-resistant prostate carcinoma, lymph node disorder, metastatic carcinoma in the bone, metastatic prostate carcinoma +2 M.D. Anderson Cancer Center Completed No outcome recorded
Phase 1/2 NCT01511536 Mar 2012 → Jul 2014 prostate cancer Sanofi Completed No outcome recorded
Phase 1/2 NCT01497964 Dec 2011 → May 2013 gastric cancer Sanofi Completed No outcome recorded
Phase 1/2 NCT01335204 Jun 2011 → Mar 2013 prostate cancer Medical University of South Carolina Terminated No outcome recorded
Phase 262 trials
Phase 2 NCT06738303 Jul 2025 → Dec 2026 expected castration-resistant prostate carcinoma, metastatic prostate carcinoma Case Comprehensive Cancer Center Recruiting No outcome recorded
Phase 2 NCT06890832 May 2025 → Dec 2026 expected castration-resistant prostate carcinoma Jina Pharmaceuticals Inc. Not yet recruiting No outcome recorded
Phase 2 NCT06632977 Feb 2025 → Apr 2030 expected castration-resistant prostate carcinoma Alliance for Clinical Trials in Oncology Recruiting No outcome recorded
Phase 2 NCT05563558 May 2023 → Nov 2026 expected metastatic prostate carcinoma Fundacion Oncosur Recruiting No outcome recorded
Phase 2 NCT05005728 Oct 2021 → Jun 2025 castration-resistant prostate carcinoma Xencor, Inc. Completed No outcome recorded
Phase 2 NCT04709276 Jun 2021 → Feb 2026 overdue metastatic prostate carcinoma, prostate neuroendocrine neoplasm Andrew J. Armstrong, MD Active not recruiting No outcome recorded
Phase 2 NCT04622761 Jan 2021 → Nov 2025 prostate cancer The Clatterbridge Cancer Centre NHS Foundation Trust Unknown No outcome recorded
Phase 2 NCT04592237 Dec 2020 → Dec 2027 expected castration-resistant prostate carcinoma, metastatic prostate carcinoma, prostate small cell carcinoma M.D. Anderson Cancer Center Active not recruiting No outcome recorded
Phase 2 NCT04495179 Aug 2020 → Nov 2021 castration-resistant prostate carcinoma AstraZeneca Completed No outcome recorded
Phase 2 NCT03934840 Oct 2019 → Jun 2023 prostate cancer Masonic Cancer Center, University of Minnesota Completed No outcome recorded
Phase 2/33 trials
Phase 2/3 NCT03258320 Jan 2015 → Dec 2026 expected prostate cancer Shanghai Jiao Tong University School of Medicine Recruiting No outcome recorded
Phase 2/3 NCT01668459 Jan 2013 → Nov 2017 transitional cell carcinoma Dr Anjali Zarkar Completed No outcome recorded
Phase 2/3 NCT01830231 Oct 2012 → Nov 2016 urothelial carcinoma Associació per a la Recerca Oncologica, Spain Unknown No outcome recorded
Phase 38 trials
Phase 3 NCT02961257 May 2017 → Dec 2021 metastatic prostate carcinoma Association Pour La Recherche des Thérapeutiques Innovantes en Cancérologie Completed No outcome recorded
Phase 3 NCT02044354 May 2014 → Apr 2017 prostate carcinoma Gustave Roussy, Cancer Campus, Grand Paris Completed No outcome recorded
Phase 3 NCT01952223 Dec 2013 → Dec 2025 overdue prostate adenocarcinoma UNICANCER Active not recruiting No outcome recorded
Phase 3 NCT01978873 Nov 2012 → Nov 2018 prostate cancer Örebro University, Sweden Unknown No outcome recorded
Phase 3 NCT01308567 May 2011 → Sep 2015 prostate cancer Sanofi Completed No outcome recorded
Phase 3 NCT01308580 Apr 2011 → Aug 2015 prostate cancer Sanofi Completed No outcome recorded
Phase 3 NCT01254279 Dec 2010 → Dec 2014 metastatic prostate carcinoma Sanofi Completed No outcome recorded
Phase 3 NCT00417079 Jan 2007 → Sep 2009 prostate neoplasm Sanofi Completed No outcome recorded
Phase 44 trials
Phase 4 NCT02485691 Nov 2015 → Mar 2019 metastatic prostate carcinoma Sanofi Completed No outcome recorded
Phase 4 NCT02441894 Apr 2015 → Feb 2016 prostate cancer Sanofi Completed No outcome recorded
Phase 4 NCT02074137 Jul 2014 → Mar 2016 metastatic prostate carcinoma Sanofi Completed No outcome recorded
Phase 4 NCT01649635 Jul 2012 → Jan 2014 prostate cancer Sanofi Completed No outcome recorded
Phase not applicable1 trial
NCT02551718 Sep 2015 → Jun 2020 acute leukemia of ambiguous lineage, acute lymphoblastic leukemia University of Washington Completed No outcome recorded
Also used as a comparator or background therapy in 17 trials
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 11 trial
Phase 1 NCT03043989 Comparator Mar 2017 → Jul 2019 prostate cancer Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Terminated No outcome recorded
Phase 1/21 trial
Phase 1/2 NCT06085729 Background Feb 2024 → Sep 2027 expected prostate cancer M.D. Anderson Cancer Center Recruiting No outcome recorded
Phase 26 trials
Phase 2 NCT05762536 Background Nov 2023 → May 2027 expected prostate carcinoma Erasmus Medical Center Recruiting No outcome recorded
Phase 2 NCT03556904 Background Dec 2018 → Jul 2023 prostate cancer University of Michigan Rogel Cancer Center Completed No outcome recorded
Phase 2 NCT03248570 Background Feb 2018 → Sep 2023 castration-resistant prostate carcinoma, metastatic prostate carcinoma University of California, San Francisco Completed No outcome recorded
Phase 2 NCT03392428 Comparator Jan 2018 → Dec 2019 metastatic malignant neoplasm, prostate cancer Australian and New Zealand Urogenital and Prostate Cancer Trials Group Completed No outcome recorded
Phase 2 NCT02703623 Comparator May 2016 → Mar 2028 expected castration-resistant prostate carcinoma, metastatic prostate carcinoma, prostate adenocarcinoma M.D. Anderson Cancer Center Active not recruiting No outcome recorded
Phase 2/31 trial
Phase 2/3 NCT03295565 Comparator May 2017 → Dec 2020 metastatic neoplasm, metastatic prostate carcinoma The Netherlands Cancer Institute Completed No outcome recorded
Phase 38 trials
Phase 3 NCT07611110 Comparator May 2026 → Feb 2029 expected prostate carcinoma AstraZeneca Recruiting No outcome recorded
Phase 3 NCT07213674 Comparator Nov 2025 → Jan 2030 expected prostate carcinoma Amgen Recruiting No outcome recorded
Phase 3 NCT06855277 Comparator Jul 2025 → Sep 2028 expected prostate cancer Novartis Pharmaceuticals Recruiting No outcome recorded
Phase 3 NCT06691984 Comparator Dec 2024 → Jan 2029 expected castration-resistant prostate carcinoma Amgen Active not recruiting No outcome recorded
Phase 3 NCT06470243 Background Nov 2024 → Jun 2029 expected castration-resistant prostate carcinoma SWOG Cancer Research Network Recruiting No outcome recorded

Evidence & citations 14 cited values

Every value below carries the sentence it was read from. 122 sources stand behind the page.

FieldValueCited text
Known as CABAZITAXEL “Current systemic therapy is most commonly a second generation androgen pathway inhibitor, including enzalutamide or abiraterone, although other standard agents (e.g. docetaxel,...” NCT03556904
116

“Chemotherapy regimen will be at the discretion of the treating physician, and may consist of docetaxel or cabazitaxel with or without a platinum agent (e.g. carboplatin).” NCT03248570

“The trial doctor will select either an ARPI of enzalutamide or abiraterone, or a taxane based chemotherapy of docetaxel or cabazitaxel or \[177Lu\]Lu-PSMA-617 (AAA617).” NCT06855277

Cabazitaxel 25 mg/m² i.v. (Day 1) every 3 weeks (cycle) as 1-hour i.v infusion” NCT01779479

“Jevtana® (cabazitaxel) 16 mg/m2 IV in 1 hour on day 1 given every second week” NCT01558219

“Busulfan Cabazitaxel Cabozantinib” NCT02551718

NCT01576029

NCT03043989

NCT01952223

NCT06738303

NCT03878524

NCT01649635

NCT01505868

NCT01956149

NCT02441894

NCT03048942

NCT03392428

NCT02512458

NCT02543255

NCT01324583

NCT01578655

NCT02204332

NCT04709276

NCT06691984

NCT02202772

NCT02478502

NCT01511536

NCT01934894

NCT07611110

NCT02115165

NCT01941550

NCT05818683

NCT03263650

NCT06890832

NCT02844582

NCT03050866

NCT02522715

NCT02254785

NCT01620242

NCT00417079

NCT03258320

NCT06470243

NCT03764540

NCT01650285

NCT01335204

NCT05563558

NCT01437488

NCT01852578

NCT01379339

NCT01541007

NCT01830231

NCT01420250

NCT02621190

NCT01757171

NCT01518283

NCT02485691

NCT01469338

NCT04622761

NCT03419234

NCT01751308

NCT01693549

NCT01750866

NCT01755390

NCT06632977

NCT04592237

NCT07213674

NCT02218606

NCT01747239

NCT01866449

NCT01500720

NCT01913652

NCT01913067

NCT06353386

NCT04495179

NCT01600339

NCT06085729

NCT03934840

NCT02166658

NCT01140607

NCT01981668

NCT01740570

NCT01447225

NCT02985957

NCT01087021

NCT01001221

NCT01254279

NCT01718353

NCT03101046

NCT01497964

NCT02703623

NCT01668459

NCT05340374

NCT01308580

NCT01308567

NCT03356912

NCT03114254

NCT01978873

NCT01083615

NCT03110588

NCT02035124

NCT02560337

NCT01594918

NCT05762536

NCT00925743

NCT01616875

NCT01527929

NCT01528163

NCT02379390

NCT02961257

NCT03295565

NCT05005728

NCT03257891

NCT02074137

NCT01845792

NCT01531205

NCT02903160

NCT03903835

Known as Cabazitaxel accord ChEMBL registry synonym — accepted as the source's own label CHEMBL1201748
Known as Cabazitaxel acetonate ChEMBL registry synonym — accepted as the source's own label CHEMBL1201748
Known as Cabazitaxel-XRP6258 ClinicalTrials.gov intervention name — accepted as the source's own label NCT01438307
Known as Jevtana Jevtana® (cabazitaxel) 16 mg/m2 IV in 1 hour on day 1 given every second week” NCT01558219
3

“Cabazitaxel (Jevtana®) is a new taxane” NCT01747239

NCT02044354

NCT01365130

Known as JEVTANA (cabazitaxel) “JEVTANA® (cabazitaxel)” NCT01335204
Known as Jevtana kit ChEMBL registry synonym — accepted as the source's own label CHEMBL1201748
Known as NSC-761432 ChEMBL registry synonym — accepted as the source's own label CHEMBL1201748
Known as RPR116258 “cabazitaxel (XRP6258) (RPR116258)” NCT00417079
Known as TXD 258 ChEMBL registry synonym — accepted as the source's own label CHEMBL1201748
Known as XRP6258 “Cabazitaxel (XRP6258) is a new taxoid, which promotes tubulin assembly in vitro and stabilizes microtubules against cold-induced depolymerization as efficiently as docetaxel” NCT01528163
17

“cabazitaxel (XRP6258) (RPR116258)” NCT00417079

“Drug: Cabazitaxel (XRP6258)” NCT01324583

“Drug: CABAZITAXEL (XRP6258)” NCT01649635

“Drug: CABAZITAXEL XRP6258NCT02074137

“CABAZITAXEL (XRP6258)” NCT01718353

“Cabazitaxel (XRP6258)” NCT01087021

“Cabazitaxel (XRP6258)” NCT01308567

“Cabazitaxel (XRP6258)” NCT01308580

“Cabazitaxel (XRP6258)” NCT01751308

“Cabazitaxel (XRP6258)” NCT01755390

“Cabazitaxel (XRP6258)” NCT01140607

“cabazitaxel (XRP6258)” NCT00925743

“cabazitaxel XRP6258NCT02485691

“Cabazitaxel XRP6258NCT02379390

“cabazitaxel XRP6258NCT01497964

“Cabazitaxel XRP6258NCT01527929

“Cabazitaxel XRP6258NCT01511536

Action Inhibit “thus inhibit mitosis” NCT05340374
Modality Other / unclassified “Cabazitaxel is an agent in the taxane family designed to be active in the setting of acquired multi-drug resistance that arises in some tumors.” NCT01437488
Route Intravenous “25 mg/m(2) cabazitaxel intravenously over 1 h every 3 weeks.” PMID 20888992 Oct 2010