In short
Cabazitaxel 2-PROPANOL solvate is a chemically synthesised microtubule inhibitor used in metastatic castration-resistant prostate cancer (mCRPC). It is already authorised as a medicine and appears as a comparator in one registered trial. Two clinical trials in the provided data involve this substance: one Phase 1 study with 311 participants and one Phase 2 study with 60 participants.
Key points
- Cabazitaxel is a microtubule inhibitor authorised for metastatic castration-resistant prostate cancer after docetaxel treatment.
- It is given as an intravenous infusion, typically at 20 mg/m² every three weeks with oral prednisone.
- In the provided data, cabazitaxel appears as a comparator in one trial and as an intervention in another.
- The Phase 1 trial (NCT06353386) has 311 participants and tests cabazitaxel as part of combination therapy in mCRPC.
- The Phase 2 trial (2025-521051-23-00) has 60 participants and compares darolutamide plus bipolar androgen therapy against standard of care.
- Known serious side effects include neutropenia and severe hypersensitivity reactions.
What is cabazitaxel 2-PROPANOL solvate?
Cabazitaxel 2-PROPANOL solvate is a chemically synthesised substance classified as a taxane derivative and antineoplastic agent (ATC code L01CD04). It is also known as cabazitaxel, Jevtana, RPR-116258A, and XRP-6258. The substance is already authorised as a medicine. In the provided registry data, cabazitaxel appears as a comparator in one trial.
How does cabazitaxel work?
Cabazitaxel is a microtubule inhibitor. It binds to tubulin and promotes its assembly into microtubules while simultaneously inhibiting their disassembly. This stabilises microtubules and prevents cell division, which leads to the death of rapidly dividing cancer cells.
Which conditions is cabazitaxel used or studied for?
- Metastatic castration-resistant prostate cancer (mCRPC) — a form of advanced prostate cancer that continues to grow despite treatments that lower testosterone. Cabazitaxel is indicated in combination with prednisone for patients previously treated with a docetaxel-containing regimen.
How is cabazitaxel given?
Cabazitaxel is given as an intravenous infusion. The recommended dose is 20 mg/m² administered every three weeks as a one-hour intravenous infusion in combination with oral prednisone 10 mg daily. A dose of 25 mg/m² can be used in select patients at the discretion of the treating healthcare provider. In the registry data, the route of administration is recorded as IV infusion.
What do the clinical trials show?
Two trials in the provided data involve cabazitaxel. In the Phase 1 trial NCT06353386, cabazitaxel is listed as an intervention in a study of MK-5684-based therapies in advanced prostate cancer with 311 participants. The primary outcomes include dose-limiting toxicities, adverse events, discontinuations due to adverse events, and prostate-specific antigen (PSA) response rate.
In the Phase 2 trial 2025-521051-23-00, cabazitaxel is listed as an intervention in a study comparing darolutamide and bipolar androgen therapy against standard of care in mCRPC with 60 participants. The primary outcomes are progression-free survival (PFS) and quality of life measured with the FACIT-F scale. Both trials are currently authorised.
What side effects are known?
The prescribing information highlights neutropenia and severe hypersensitivity as serious risks. Neutropenic deaths have been reported, and cabazitaxel is contraindicated in patients with neutrophil counts of 1,500 cells/mm³ or lower. Severe hypersensitivity can occur and may include generalised rash, erythema, hypotension, and bronchospasm. Cabazitaxel is also contraindicated in patients with a history of severe hypersensitivity to cabazitaxel or polysorbate 80, and in patients with severe hepatic impairment.