Drug · Small Molecule

Cabazitaxel

CI-DRUG-00000130Explore in graph →NCIt C66937 CHEMBL1201748 CIViC Approved

Regulatory

Approvals (13)

Each record names the authority, jurisdiction, indication text and status. A drug approved in one jurisdiction for one indication is not 'approved' in general.

openfdaRegulatory4 approval records · authority, jurisdiction and indication text as published.

Jurisdiction · authority	Cancer	Indication	Status	Approval date	Source
US FDA	—	Efficacy supplement 2020-12-18 (see label)	approved	Dec 18, 2020	openfda
US FDA	—	Efficacy supplement 2017-09-14 (see label)	approved	Sep 14, 2017	openfda
US FDA	—	Efficacy supplement 2017-05-17 (see label)	approved	May 17, 2017	openfda
US FDA	Castration-Resistant Prostate Carcinoma	JEVTANA ® is indicated in combination with prednisone for the treatment of patients with metastatic castration-resistant prostate cancer previously treated with a docetaxel-containing treatment regimen. JEVTANA is a microtubule inhibitor indicated in combination with prednisone for treatment of patients with metastatic castration-resistant prostate cancer previously treated with a docetaxel-containing treatment regimen. ( 1 )

Health Canada records are DIN-level: one row per marketed product (brand, strength, form). The Drug Product Database does not publish indications, so no cancer is stated for these rows, and a cancelled or dormant DIN is the status of that one product — not a withdrawal of the molecule.

Data updated 17 hours agoSource updated unknown

Derived

Development pipeline

Most advanced stage across all cancers, then per top-level cancer reached through trial conditions or approval indications. Approval in any ingested jurisdiction outranks trial phase; counts are interventional studies.

Scope	Stage	Max phase	Active	Recruiting	Phase 3	Trials	Approvals	Jurisdictions	First approval	First trial
All cancers	Approved	Phase 4	19	9	17	102	13	CA, EU, US	Jun 17, 2010	1999-10
Malignant Prostate Neoplasm	Approved	Phase 4	15	6	10	45	3	EU, US	Jun 17, 2010	2011-01
Malignant Bladder Neoplasm	Phase2	Phase 2	1	0	0	1	0	—	—	Dec 1, 2014
Malignant Breast Neoplasm	Phase2	Phase 2	0	0	0	4	0

Curated evidence

Clinical evidence (3)

CIViC items in which this therapy appears, grouped by cancer context, then molecular profile. 50 items per page.

civicCuratedShowing 1–3 of 3 evidence items · levels, directions and significance as curated at the source; each row links to its CIViC record.

Therapy	Cancer	Type	Level	Direction · significance	Rating (1–5)	Status	Evidence	Source
AR AR-V71
Cabazitaxel	Malignant Prostate Neoplasm

Clinical trials

Trials with this intervention (104)

Most recently updated first, 50 per page.

clinicaltrialsPublishedShowing 101–104 of 104 studies · status and phase as posted by the registrant; each row links to the study record.

NCT	Title	Status	Phase	Enrollment (n)	Sponsor	Countries	Last update	Source
NCT00925743	A Study to Evaluate the Effects of Combining Cabazitaxel With Cisplatin Given Every 3 Weeks in Patients With Advanced Solid Cancer	completed	Phase 1	76	SanofiINDUSTRY	1	May 16, 2013	clinicaltrials
NCT01755390	A Dose Finding Study of XRP6258 in Patients With Advanced Solid Tumors	completed	Phase 1

Molecule

Record

Kind: Small Molecule
Mechanism: Tubulin inhibitor
Targets: 15 genes
Aliases: 1-hydroxy-7beta,10beta-dimethoxy-9-oxo-5beta,20-epoxytax-11-ene-2alpha,4,13alpha-triyl 4-acetate 2-benzoate 13-[(2R,3S)-3-{[(tertbutoxy)carbonyl]amino}-2-hydroxy-3-phenylpropanoate], Cabazitaxel, Cabazitaxel accord, Cabazitaxel acetonate, Jevtana, JEVTANA, Jevtana kit, NSC-761432, RPR 116258A, RPR116258A, Taxoid XRP6258, TXD 258, TXD258, XRP 6258, XRP6258

Data updated 20 hours agoSource updated unknown

Identifiers

Codes (18)

Upstream identifiers kept as first-class codes; each links to its registry where a stable public URL exists.

System	Code	Label
ATC (WHO)	L01CD	Antineoplastic agents
ATC (WHO)	L01CD04	CABAZITAXEL
DIN (Health Canada)

IGF2 Overexpression2
Cabazitaxel + LinsitinibCombination	Malignant Prostate Neoplasm	Predictive	D	Supports Sensitivity Response	3	submitted	EID12428 OSI-906, an IGF1R/INSR inhibitor, sensitizes cell lines to cabazitaxel, resulting in better overall survival in mouse xenografts of patient derived chemotherapy resistant castration-resistant prostate… (full text at CIViC) PMID 25670080 · Vidal et al., 2015 · Open in CIViC	civic
Cabazitaxel + Docetaxel + LinsitinibSubstitutes	Malignant Prostate Neoplasm	Predictive	D	Supports Sensitivity Response	3	accepted	EID414 OSI-906, an IGF1R/INSR inhibitor, sensitizes cell lines to docetaxel and cabazitaxel, resulting in better overall survival in mouse xenografts of patient derived chemotherapy resistant castration-resi… (full text at CIViC) PMID 25670080 · Vidal et al., 2015 · Open in CIViC	civic