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

Comparison of Cabazitaxel/Prednisone Alone or in Combination With Custirsen for 2nd Line Chemotherapy in Prostate Cancer

Phase 3

Completed

Conditions: Prostate Cancer

Interventions: Drug: cabazitaxel
Drug: prednisone
Drug: custirsen sodium

First Posted Date: 2012-04-17

Last Posted Date: 2016-10-12

Lead Sponsor: Achieve Life Sciences

Target Recruit Count: 630

Registration Number: NCT01578655

Locations: 🇺🇸
Georgia Cancer Specialists, P.C., Marietta, Georgia, United States
🇨🇦
Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada
🇨🇿
Krajská nemocnice Liberec a.s., Liberec, Czech Republic

and more 90 locations

Continued Treatment With Docetaxel Versus Switch to Cabazitaxel After Minor Prostate Specific Antigen Response to Docetaxel in Patients With Castration-Resistant Metastatic Prostate Cancer

Phase 2

Completed

Conditions: Prostatic Neoplasms

Interventions: Drug: DOCETAXEL (XRP6976)
Drug: CABAZITAXEL (XRP6258)

First Posted Date: 2012-04-12

Last Posted Date: 2013-12-24

Lead Sponsor: Sanofi

Target Recruit Count: 2

Registration Number: NCT01576029

Locations: 🇧🇷
Investigational Site Number 004, Barretos, Brazil
🇧🇷
Investigational Site Number 001, Rio De Janeiro, Brazil
🇧🇷
Investigational Site Number 006, Rio De Janeiro, Brazil

and more 5 locations

A Study Looking at Novel Scheduling of Cabazitaxel for Patients With Metastatic Prostate Cancer

Phase 2

Completed

Conditions: Metastatic Castration Resistant Prostate Cancer

Interventions: Drug: Cabazitaxel
Drug: weekly cabazitaxel

First Posted Date: 2012-02-29

Last Posted Date: 2015-11-01

Lead Sponsor: Jeffrey Yachnin M.D., PhD.

Target Recruit Count: 100

Registration Number: NCT01541007

Locations: 🇸🇪
Deapartment of Oncology Karolinska University Hospital, Stockholm, Sweden

Neoadjuvant Chemohormonal Therapy Followed by Salvage Surgery for High Risk PSA

Phase 2

Terminated

Conditions: Prostate Cancer

Interventions: Drug: Androgen Ablation
Drug: Cabazitaxel
Drug: Salvage Therapy
Drug: Neoadjuvant Treatment - Hormonal Therapy
Drug: Neoadjuvant Treatment - Cabazitaxel

First Posted Date: 2012-02-10

Last Posted Date: 2014-11-05

Lead Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Target Recruit Count: 2

Registration Number: NCT01531205

Locations: 🇺🇸
H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida, United States

Pharmacokinetics and Safety Study of Cabazitaxel in Cancer Patients With Renal Impairment

Phase 1

Completed

Conditions: Neoplasm Malignant

Interventions: Drug: Cabazitaxel XRP6258

First Posted Date: 2012-02-07

Last Posted Date: 2013-12-04

Lead Sponsor: Sanofi

Target Recruit Count: 25

Registration Number: NCT01527929

Locations: 🇧🇪
Investigational Site Number 056002, Bruxelles, Belgium
🇧🇪
Investigational Site Number 056001, Gent, Belgium
🇳🇱
Investigational Site Number 528002, Utrecht, Netherlands

and more 4 locations

Study Comparing Two Treatments in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck

Phase 2

Completed

Conditions: Squamous Cell Carcinoma of the Head and Neck

Interventions: Drug: Cabazitaxel
Drug: Methotrexate

First Posted Date: 2012-02-07

Last Posted Date: 2017-06-14

Lead Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Target Recruit Count: 101

Registration Number: NCT01528163

Locations: 🇧🇪
Grand Hôpital de Charleroi, Charleroi, Hainaut, Belgium
🇱🇺
Centre Hospitalier de Luxembourg, Luxembourg, Luxembourg
🇧🇪
Hôpital de Jolimont, Haine-Saint-Paul, Hainaut, Belgium

and more 13 locations

Study of Weekly Cabazitaxel for Advanced Prostate Cancer

Phase 2

Completed

Conditions: Hormone Refractory Prostate Cancer

Interventions: Drug: Cabazitaxel 10 mg/m2

First Posted Date: 2012-01-25

Last Posted Date: 2017-07-02

Lead Sponsor: Spanish Oncology Genito-Urinary Group

Target Recruit Count: 74

Registration Number: NCT01518283

Locations: 🇪🇸
Hospital Clinic I Provincial de Barcelona, Barcelona, Spain
🇪🇸
Institut Català D'Oncologia L'Hospitalet (Ico), L'Hospitalet de Llobregat, Barcelona, Spain
🇪🇸
Complejo Hospitalario Universitario de Santiago, Santiago de Compostela, A Coruña, Spain

and more 9 locations

Cabazitaxel and Abiraterone Acetate in Patients With Metastatic Castrate-Resistant Prostate Cancer

Phase 1

Completed

Conditions: Prostate Cancer

Interventions: Drug: Cabazitaxel XRP6258
Drug: Abiraterone acetate
Drug: Prednisone 5 mg

First Posted Date: 2012-01-18

Last Posted Date: 2016-07-28

Lead Sponsor: Sanofi

Target Recruit Count: 38

Registration Number: NCT01511536

Locations: 🇬🇧
Investigational Site Number 826001, Sutton, United Kingdom
🇺🇸
Investigational Site Number 840002, New Haven, Connecticut, United States
🇺🇸
Investigational Site Number 840001, San Francisco, California, United States

and more 1 locations

Cabazitaxel With or Without Carboplatin in Treating Patients With Previously Treated Metastatic Castration-Resistant Prostate Cancer

Phase 1

Completed

Conditions: Castration Levels of Testosterone
Castration-Resistant Prostate Carcinoma
Lymphadenopathy
Metastatic Prostate Carcinoma
Prostate Adenocarcinoma
Prostate Small Cell Carcinoma
Prostate Carcinoma Metastatic in the Bone

Interventions: Drug: Cabazitaxel
Other: Laboratory Biomarker Analysis
Drug: Carboplatin

First Posted Date: 2012-01-09

Last Posted Date: 2021-07-30

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 170

Registration Number: NCT01505868

Locations: 🇺🇸
Wayne State University/Karmanos Cancer Institute, Detroit, Michigan, United States
🇺🇸
M D Anderson Cancer Center, Houston, Texas, United States

Cabazitaxel Compared to Topotecan for the Treatment of Small Cell Lung Cancer

Phase 2

Completed

Conditions: Small Cell Lung Cancer

Interventions: Drug: Cabazitaxel
Drug: Topotecan

First Posted Date: 2011-12-28

Last Posted Date: 2015-04-13

Lead Sponsor: Sanofi

Target Recruit Count: 179

Registration Number: NCT01500720

Locations: 🇷🇴
Investigational Site Number 642001, Craiova, Romania
🇬🇷
Investigational Site Number 300005, Athens, Greece
🇺🇸
Investigational Site Number 840006, Lebanon, New Hampshire, United States

and more 55 locations

Drug Development Updates

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