Cabazitaxel (XRP6258)

DRUG11 trials

Sponsors

Sanofi

Conditions

Advanced Solid TumorMalignant Solid Tumor - Malignant Nervous System NeoplasmNeoplasm MalignantNeoplasms, MalignantProstate CancerProstate Cancer MetastaticProstatic NeoplasmsSolid Cancer

Phase 1

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

CompletedNCT00925743

SanofiSolid Cancer

Start: 2009-06-30End: 2013-03-31Updated: 2013-05-16

Effect of Cabazitaxel on the QTc Interval in Cancer Patients

CompletedNCT01087021

SanofiNeoplasms, Malignant

Start: 2010-03-31End: 2011-11-30Updated: 2011-12-16

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

CompletedNCT01140607

SanofiNeoplasm Malignant

Start: 2010-05-31End: 2014-07-31Updated: 2015-07-21

Dose Escalation Study With Cabazitaxel in Combination With Daily Prednisolone in Patients With Hormone Refractory Prostate Cancer

CompletedNCT01324583

SanofiProstate Cancer

Start: 2011-01-31End: 2014-11-30Updated: 2015-01-07

Safety and Efficacy of Cabazitaxel in Pediatric Patients With Refractory Solid Tumors Including Central Nervous System Tumors

CompletedNCT01751308

SanofiMalignant Solid Tumor - Malignant Nervous System Neoplasm

Start: 2013-02-28End: 2016-02-29Updated: 2016-08-12

A Dose Finding Study of XRP6258 in Patients With Advanced Solid Tumors

CompletedNCT01755390

SanofiAdvanced Solid Tumor

Start: 1999-10-31End: 2002-10-31Updated: 2012-12-24

Phase 2

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

CompletedNCT01576029

SanofiProstatic Neoplasms

Start: 2012-08-31End: 2013-12-31Updated: 2013-12-24

Early Switch From First-Line Docetaxel/Prednisone to Cabazitaxel/Prednisone and the Opposite Sequence, Exploring Molecular Markers in Men With Metastatic Castration-Resistant Prostate Cancer (mCRPC)

CompletedNCT01718353

SanofiProstate Cancer Metastatic

Start: 2013-03-31End: 2015-08-31Updated: 2017-11-20

Phase 3

Cabazitaxel at 20 mg/m² Compared to 25 mg/m² With Prednisone for the Treatment of Metastatic Castration Resistant Prostate Cancer

CompletedNCT01308580

SanofiProstate Cancer

Start: 2011-04-30End: 2015-08-31Updated: 2017-04-17

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

CompletedNCT01308567

SanofiProstate Cancer

Start: 2011-05-05End: 2018-05-31Updated: 2019-06-05

Phase 4

Study of Cabazitaxel Combined With Prednisone and Prophylaxis of Neutropenia Complications in the Treatment of Patients With Metastatic Castration-resistant Prostate Cancer

CompletedNCT01649635

SanofiProstate Cancer

Start: 2012-07-31End: 2016-06-30Updated: 2016-07-06

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Phase III Study Comparing a Reduced Dose of Cabazitaxel (20 mg/m<sup>2</sup>) and the Currently Approved Dose (25 mg/m<sup>2</sup>) in Postdocetaxel Patients With Metastatic Castration-Resistant Prostate Cancer—PROSELICA

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Cabazitaxel Versus Docetaxel As First-Line Therapy for Patients With Metastatic Castration-Resistant Prostate Cancer: A Randomized Phase III Trial—FIRSTANA

Journal of Clinical Oncology2017-07-28350 citations

Randomized, Noncomparative, Phase II Trial of Early Switch From Docetaxel to Cabazitaxel or Vice Versa, With Integrated Biomarker Analysis, in Men With Chemotherapy-Naïve, Metastatic, Castration-Resistant Prostate Cancer

Journal of Clinical Oncology2017-06-2081 citations

AR nuclear localization and microtubule bundling as markers of docetaxel and cabazitaxel sensitivity in metastatic castration-resistant prostate cancer (mCRPC): Prospective biomarker analysis from TAXYNERGY.

Journal of Clinical Oncology2017-02-20

Cabazitaxel vs docetaxel in chemotherapy-naive (CN) patients with metastatic castration-resistant prostate cancer (mCRPC): A three-arm phase III study (FIRSTANA).

Journal of Clinical Oncology2016-05-2053 citations

Phase III non-inferiority study of cabazitaxel (C) 20 mg/m<sup>2</sup> (C20) versus 25 mg/m<sup>2</sup> (C25) in patients (pts) with metastatic castration-resistant prostate cancer (mCRPC) previously treated with docetaxel (D).

Journal of Clinical Oncology2016-05-2039 citations

TAXYNERGY: Randomized trial of early switch from first-line docetaxel (D) to cabazitaxel (C) or vice versa with circulating tumor cell (CTC) biomarkers in patients (pts) with metastatic castration-resistant prostate cancer (mCRPC).

Journal of Clinical Oncology2016-05-205 citations

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