Cabazitaxel

Generic Name: Cabazitaxel

Brand Names: Jevtana, Cabazitaxel Accord

Drug Type: Small Molecule

Chemical Formula: C_₄₅H_₅₇NO_₁₄

CAS Number: 183133-96-2

Unique Ingredient Identifier: 51F690397J

Background: Cabazitaxel is a taxoid synthesized from 10-deacetylbaccatin III, a compound isolated from the yew tree. As a second-generation semisynthetic microtubule inhibitor, cabazitaxel stabilizes microtubules and induces tumour cell death. Due to its low affinity for the P-glycoprotein (P-gp) efflux pump, cabazitaxel can more readily penetrate the blood–brain barrier compared to other taxanes like paclitaxel and docetaxel.

Cabazitaxel is used to treat metastatic castration-resistant prostate cancer. It was first approved by the FDA on June 17, 2010. It was also approved by the EMA on March 17, 2011 and Health Canada on December 17, 2019.

Indication: 用于治疗转移性去势抵抗性前列腺癌患者。

Associated Conditions: Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Clinical Trials

Cabazitaxel Versus Docetaxel Both With Prednisone in Patients With Metastatic Castration Resistant Prostate Cancer

Phase 3

Completed

Conditions: Prostate Cancer

Interventions: Drug: Cabazitaxel (XRP6258)
Drug: Docetaxel (XRP6976)
Drug: Prednisone

First Posted Date: 2011-03-04

Last Posted Date: 2019-06-05

Lead Sponsor: Sanofi

Target Recruit Count: 1168

Registration Number: NCT01308567

Locations: 🇫🇷
Investigational Site Number 250010, Besancon Cedex, France
🇺🇸
Investigational Site Number 840035, Jacksonville, Florida, United States
🇧🇾
Investigational Site Number 112001, Minsk, Belarus

and more 164 locations

Early Access to Cabazitaxel in Patients With Metastatic Hormone Refractory Prostate Cancer Previously Treated With a Docetaxel-containing Regimen

Phase 3

Completed

Conditions: Prostate Cancer Metastatic

Interventions: Drug: CABAZITAXEL

First Posted Date: 2010-12-06

Last Posted Date: 2015-01-21

Lead Sponsor: Sanofi

Target Recruit Count: 984

Registration Number: NCT01254279

Locations: 🇮🇹
Investigational Site Number 380-005, Genova, Italy
🇦🇺
Investigational Site Number 036002, Camperdown, Australia
🇦🇺
Investigational Site Number 036020, Campbelltown, Australia

and more 162 locations

Safety and Pharmacokinetic Study of Cabazitaxel in Patients With Advanced Solid Tumors and Liver Impairment

Phase 1

Completed

Conditions: Neoplasm Malignant

Interventions: Drug: Cabazitaxel (XRP6258)

First Posted Date: 2010-06-09

Last Posted Date: 2015-07-21

Lead Sponsor: Sanofi

Target Recruit Count: 56

Registration Number: NCT01140607

Locations: 🇺🇸
Investigational Site Number 840003, Metairie, Louisiana, United States
🇺🇸
Investigational Site Number 840001, St Louis, Missouri, United States
🇺🇸
Investigational Site Number 840020, Washington, District of Columbia, United States

and more 11 locations

Effect of Cabazitaxel on the QTc Interval in Cancer Patients

Phase 1

Completed

Conditions: Neoplasms, Malignant

Interventions: Drug: Cabazitaxel (XRP6258)

First Posted Date: 2010-03-15

Last Posted Date: 2011-12-16

Lead Sponsor: Sanofi

Target Recruit Count: 45

Registration Number: NCT01087021

Locations: 🇧🇪
Sanofi-Aventis Investigational Site Number 056002, Bruxelles, Belgium
🇺🇸
Sanofi-Aventis Investigational Site Number 840006, San Diego, California, United States
🇺🇸
Sanofi-Aventis Investigational Site Number 840005, Decatur, Illinois, United States

and more 12 locations

A Study Evaluating the Pain Palliation Benefit of Adding Custirsen to Docetaxel Retreatment or Cabazitaxel as Second Line Therapy in Men With Metastatic Castrate Resistant Prostate Cancer (mCRPC)

Phase 3

Terminated

Conditions: Hormone Refractory Prostate Cancer
Castrate-Resistant Prostate Cancer

Interventions: Drug: isotonic, 0.9% sodium chloride
Drug: custirsen sodium
Drug: docetaxel
Drug: cabazitaxel
Drug: prednisone

First Posted Date: 2010-03-10

Last Posted Date: 2016-10-12

Lead Sponsor: Achieve Life Sciences

Target Recruit Count: 14

Registration Number: NCT01083615

Dose-Escalation, Safety, Pharmacokinetics Study of Cabazitaxel With Gemcitabine In Patients With Solid Tumor

Phase 1

Terminated

Conditions: Neoplasms, Malignant

Interventions: Drug: cabazitaxel
Drug: gemcitabine

First Posted Date: 2009-10-26

Last Posted Date: 2013-09-11

Lead Sponsor: Sanofi

Target Recruit Count: 19

Registration Number: NCT01001221

Locations: 🇺🇸
Investigational Site Number 840004, Philadelphia, Pennsylvania, United States
🇺🇸
Investigational Site Number 840005, Cincinnati, Ohio, United States
🇺🇸
Investigational Site Number 840001, Nashville, Tennessee, United States

and more 1 locations

A Study to Evaluate the Effects of Combining Cabazitaxel With Cisplatin Given Every 3 Weeks in Patients With Advanced Solid Cancer

Phase 1

Completed

Conditions: Solid Cancer

Interventions: Drug: cabazitaxel (XRP6258)

First Posted Date: 2009-06-22

Last Posted Date: 2013-05-16

Lead Sponsor: Sanofi

Target Recruit Count: 76

Registration Number: NCT00925743

Locations: 🇺🇸
Investigational Site Number 840002, Baltimore, Maryland, United States
🇺🇸
Investigational Site Number 840010, Decatur, Illinois, United States
🇺🇸
Investigational Site Number 840003, San Diego, California, United States

and more 4 locations

XRP6258 Plus Prednisone Compared to Mitoxantrone Plus Prednisone in Hormone Refractory Metastatic Prostate Cancer

Phase 3

Completed

Conditions: Neoplasms
Prostatic Neoplasms

Interventions: Drug: cabazitaxel (XRP6258) (RPR116258)
Drug: mitoxantrone
Drug: prednisone

First Posted Date: 2006-12-29

Last Posted Date: 2011-03-10

Lead Sponsor: Sanofi

Target Recruit Count: 755

Registration Number: NCT00417079

Locations: 🇭🇺
Sanofi-Aventis Hungaria, Budapest, Hungary
🇫🇮
sanofi-aventis Finland, Helsinki, Finland
🇮🇳
sanofi-aventis India, Mumbai, India

and more 23 locations

Drug Development Updates

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