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cabazitaxel

Generic: CABAZITAXEL·Brand: CABAZITAXEL, JEVTANA KIT, Jevtana

cabazitaxel: developed by 1 company · 14 clinical trials tracked · 1 FDA decision.

cabazitaxel evidence translation

What we can confirm

1 FDA record · 14 tracked trials

What it means

Source-backed records connect cabazitaxel to SNY; that link alone does not prove the drug works.

What to watch

Watch active trials and any change in FDA or trial status.
BioSniper AIPage evidence connected

Prepared research question

How could cabazitaxel → SNY affect its developer, and what evidence supports the link?

Run cited research

Traceable citations · Unknowns marked

See linked entities and source evidence4 indications · 6 study sponsors
Development Pipeline (2)
CompanyPhase
Sanofi (SNY)Approved
Sanofi (SNY)Approved
Clinical Trials (14)showing 10 most recent

A Phase III, Multicentre, Randomised Controlled Study to Evaluate the Efficacy and Safety of AZD2265 (FPI-2265) ²²⁵Ac-PSMA-I&T Compared With Standard of Care in Patients With PSMA-positive Metastatic Castration-resistant Prostate Cancer (VECTRA-01)

NCT07611110·Phase 3·AZN
Recruiting

Primary endpoint: Radiographic Progression-Free Survival (rPFS)

InterventionalRandomizedsingle670 targetStarted 2026-05Completion 2029-1250 sites · Australia, Austria, Brazil, Canada…AstraZeneca

A Phase 3, Open-label, Multicenter, Randomized Study of Xaluritamig Plus Abiraterone Versus Investigator's Choice in Participants With Chemotherapy-naïve Metastatic Castration-resistant Prostate Cancer

NCT07213674·Phase 3·AMGN
Recruiting

Primary endpoint: OS

InterventionalRandomizedopen750 targetStarted 2025-11Completion 2032-0850 sites · Australia, Austria, United StatesAmgen

PREcision DIagnostics in Prostate Cancer Treatment (PREDICT)

NCT06632977·Phase 2
Recruiting

Primary endpoint: Objective Response

Interventionalopen474 targetStarted 2025-02Completion 2034-1050 sites · United StatesAlliance for Clinical Trials in Oncology

A Phase 3, Open-label, Multicenter, Randomized Study of Xaluritamig vs Cabazitaxel or Second Androgen Receptor-Directed Therapy in Subjects With Metastatic Castration-Resistant Prostate Cancer Previously Treated With Chemotherapy

NCT06691984·Phase 3·AMGN
Active, not recruiting

Primary endpoint: Overall Survival (OS)

InterventionalRandomizedopen707 targetStarted 2024-12Completion 2029-0750 sites · Australia, Austria, United StatesAmgen

MK-5684-01A Substudy: A Phase 1/2 Umbrella Substudy of MK-5684-U01 Master Protocol to Evaluate the Safety and Efficacy of MK-5684-based Treatment Combinations or MK-5684 Alone in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC)

NCT06353386·Phase 1·MRK
Recruiting

Primary endpoint: Number of participants who experience one or more dose-limiting toxicities (DLTs)

InterventionalRandomizedopen220 targetStarted 2024-05Completion 2029-0150 sites · Australia, Canada, Chile, Colombia…Merck Sharp & Dohme LLC

A Phase 1b Study of JNJ-78278343, Targeting Human Kallikrein 2 (KLK2) in Combination With Other Agents for Metastatic Prostate Cancer

NCT05818683·Phase 1·GHRS
Recruiting

Primary endpoint: Part 1: Number of Participants With Dose Limiting Toxicity (DLT)

Interventionalopen300 targetStarted 2023-04Completion 2028-0515 sites · Australia, Spain, United StatesJanssen Research & Development, LLC

Real World Evidence Study on Metastatic Prostate Cancer Patient Characteristics, Treatment Patterns and Outcomes in the Pirkanmaa Hospital District in Finland

Completed

Primary endpoint: Body Mass Index (BMI)

Observational1,083 enrolledStarted 2023-02Completion 2024-041 site · FinlandPfizer

A Phase II, Single Arm Study of Chemoimmunotherapy for the Treatment of Men With Neuroendocrine or Aggressive Variant Metastatic Prostate Cancer (CHAMP)

NCT04709276·Phase 2
Active, not recruiting

Primary endpoint: Proportion of subjects who are progression-free and alive (progression-free survival) at 6 months

Interventionalopen41 targetStarted 2021-06Completion 2028-083 sites · United StatesAndrew J. Armstrong, MD

Cabazitaxel With Abiraterone Versus Abiraterone Alone Randomized Trial for Extensive Disease Following Docetaxel: The CHAARTED2 Trial

NCT03419234·Phase 2
Active, not recruiting

Primary endpoint: Progression-free Survival (PFS)

InterventionalRandomizedopen223 enrolledStarted 2018-04Completion 2028-0450 sites · United StatesECOG-ACRIN Cancer Research Group

Randomized Phase II Study of Olaparib Maintenance Following Cabazitaxel-Carboplatin Induction Chemotherapy in Men With Aggressive Variant Prostate Cancer (AVPC)

NCT03263650·Phase 2
Completed

Primary endpoint: Progression-free survival (PFS) of men with AVPC treated with 6 cycles of cabazitaxel + carboplatin followed by olaparib maintenance versus observation

InterventionalRandomizedopen96 enrolledStarted 2017-10Completion 2026-061 site · United StatesM.D. Anderson Cancer Center
FDA Decisions1 records
Approval1 INDICATIONS AND USAGE 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 )(SNY)FDA ↗
NDA201023Type 1 - New Molecular EntityPriorityIntravenousSolution

Frequently asked questions

Who is developing cabazitaxel?

cabazitaxel is being developed by Sanofi.

How many clinical trials involve cabazitaxel?

BioSniper tracks 14 clinical trials involving cabazitaxel.

What is cabazitaxel's latest FDA decision?

The most recent tracked FDA decision for cabazitaxel is Approval for 1 INDICATIONS AND USAGE 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 ), dated June 17, 2010.