Drugs / Cabazitaxel
last change Jun 2026 re-read 9 days 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 · prostate neoplasm · head and neck squamous cell carcinoma · hormone-resistant prostate carcinoma · non-small cell lung 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 · 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 · Spanish Oncology Genito-Urinary Group · 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 102 · started per year

today
US approved 2010
EU approved 2011
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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 Stop: Enrollment
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 · 1 met primary
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 Met primary
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 Stop: Business
Phase 261 trials · 2 met primary · 3 missed
Phase 2 NCT06738303 Jul 2025 → Feb 2028 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 · 1 missed
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 Missed primary
Phase 38 trials · 3 met primary · 1 missed
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 Met primary
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 Missed primary
Phase 3 NCT01308580 Apr 2011 → Aug 2015 prostate cancer Sanofi Completed Met primary
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 Met primary
Phase 44 trials · 1 met primary
Phase 4 NCT02485691 Nov 2015 → Mar 2019 metastatic prostate carcinoma Sanofi Completed Met primary
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
Comparator or background therapy18 trials
Phase 1 NCT03043989 Comparator Mar 2017 → Jul 2019 prostate cancer Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Terminated No outcome recorded Stop: Enrollment
Phase 1/2 NCT06085729 Background Feb 2024 → Sep 2027 expected prostate cancer M.D. Anderson Cancer Center Recruiting No outcome recorded
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

News releases announcing trial results or a regulatory action · 17

DateIssuerRelease
2024-01-18 Starpharma Pty Ltd Results DEP cabazitaxel data presentation at ASCO GI cancer meeting starpharma.com ↗
DEP® cabazitaxel achieved disease control rates of 100% and 50%, respectively, in these advanced and typically hard-to-treat gastro-oesophageal cancers, which have a one-year survival rate of approximately 20%3,4.
2023-11-14 Starpharma Pty Ltd Results Starpharma Presents at Bell Potter Conference starpharma.com ↗
75% of the evaluable ovarian cancer patients achieved reductions of up to 95% in ovarian cancer biomarkers, CA125, or CEA.
2023-10-25 Starpharma Pty Ltd Results SPL to present DEP radiotheranostics at Wilsons Conference starpharma.com ↗
DEP® cabazitaxel achieved a disease control rate (DCR) of 66.7% and an objective response rate (ORR) of 17.6%
2023-10-17 Starpharma Pty Ltd Results Positive DEP Cabazitaxel Phase 2 Results in Multiple Cancer starpharma.com ↗
Starpharma (ASX: SPL, OTCQX: SPHRY) today announces the final positive results from its completed Phase 2 open-label clinical trial of DEP® cabazitaxel.
2023-06-23 Starpharma Pty Ltd Results Life Sciences Investor Forum Presentation starpharma.com ↗
2022-11-10 Xencor, Inc. Results Xencor Presents Early Clinical Data from Combination Study of Vudalimab and New Data from Multiple Preclinical-stage XmAb® Programs at the SITC Annual Meeting xencor.com ↗
As of the data cut on September 7, 2022 , prostate-specific antigen (PSA) reductions of more than 50% from baseline (PSA50) had been observed in three of nine patients, inclusive of all cohorts and time on study.
2022-09-15 Starpharma Pty Ltd Results Starpharma to present at Life Sciences Investor Forum starpharma.com ↗
the latest interim clinical trial results presented at ESMO oncology conference that show efficacy signals in 100% of prostate cancer patients assessed following DEP® cabazitaxel treatment;
2022-09-11 Starpharma Pty Ltd Results New clinical data for DEP cabazitaxel in prostate cancer starpharma.com ↗
2022-07-25 NATCO Pharma Ltd. Regulatory NATCO Announces Approval of its ANDA for Cabazitaxel Intravenous Solution (generic for Jevtana Kit®) natcopharma.co.in ↗
Natco Pharma Limited (NSE: NATCOPHARM; BSE: 524816) announces today that the U.S. Food and Drug Administration has granted approval to its partner Breckenridge Pharmaceutical Inc’s Abbreviated New Drug Application for Cabazitaxel Intravenous Powder (generic for Jevtana Kit®) for the 60mg/1.5mL (40mg/mL) strength.
2021-11-25 Starpharma Pty Ltd Results Positive DEP phase 2 interim results in prostate cancer starpharma.com ↗
Starpharma reports positive interim results for the prostate cancer cohort in its phase 2 DEP® cabazitaxel clinical trial, all of whom have hormone refractory, Stage IV metastatic disease
2020-01-29 Starpharma Pty Ltd Results Shareholder Update January 2020 starpharma.com ↗
In phase 1, e ncouraging efficacy signals were observed in 67% of patients assessed and included prolonged stable disease in multiple tumour types, including prostate cancer.
2019-12-09 Starpharma Pty Ltd Results DEP cabazitaxel progresses to phase 2 on positive results starpharma.com ↗
The trial met its objective of evaluating safety, tolerability and preliminary efficacy data, and identifying a recommended phase 2 dose of 20 mg/m2.

All press releases naming this drug 20 releases

DateIssuerRelease

Evidence & citations 13 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 ↗
117

“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 ↗

NCT07611110 ↗

NCT01505868 ↗

NCT03356912 ↗

NCT07213674 ↗

NCT03878524 ↗

Show 107 more sources

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 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)” NCT01649635 ↗

“Drug: Cabazitaxel (XRP6258)” NCT01324583 ↗

“Drug: CABAZITAXEL XRP6258” NCT02074137 ↗

“Cabazitaxel (XRP6258)” NCT01140607 ↗

“CABAZITAXEL (XRP6258)” NCT01718353 ↗

“Cabazitaxel (XRP6258)” NCT01308580 ↗

“Cabazitaxel (XRP6258)” NCT01751308 ↗

“Cabazitaxel (XRP6258)” NCT01755390 ↗

“Cabazitaxel (XRP6258)” NCT01308567 ↗

Show 7 more sources

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