Table 3.
Ongoing clinical trials of cabazitaxel.
| ClinicalTrials.gov identifier | Trial summary | Study phase/enrollment | Primary endpoint | Target completion date |
|---|---|---|---|---|
| Dose and frequency | ||||
| NCT01518283 | 4 weekly cabazitaxel 10 mg/m2 of 5-week cycle | II (n = 74) | PSA progression | September 2014 |
| NCT01558219 | Cabazitaxel 16 mg/m2 every 2 weeks | II (n = 60) | Safety and tolerability | December 2014 |
| NCT01541007 | 5 weekly cabazitaxel 10 mg/m2 of 6-week cycle | II (n = 100) | Cumulative dose | June 2015 |
| NCT01308580 | Compare 20 mg/m2 with 25 mg/m2 | III (n = 1200) | Overall survival | September 2017 |
| Combination therapy (with cabazitaxel) | ||||
| NCT01845792 | Abiraterone/prednisone | I/II (n = 72) | PSA reduction | July 2019 |
| NCT01505868 | Carboplatin | I/II (n = 178) | Progression-free survival | July 2029 |
| NCT01578655 | Custirsen | III (n = 630) | Overall survival | December 2015 |
| NCT01083615 | Custirsen | III (n = 292) | Pain palliation | December 2013 |
| NCT01650285 | Cabazitaxel with radiation | II (n = 24) | Maximum tolerated dose | January 2016 |
| NCT01952223 | Cabazitaxel with radiation | III (n = 1048) | Progression-free survival | September 2026 |
| Other disease states | ||||
| NCT01576029 | Early switch to cabazitaxel | II (n = 78) | PSA progression | November 2014 |
| NCT01718353 | Early switch from docetaxel to cabazitaxel and opposite sequence | II (n = 100) | PSA and circulating tumor cells | July 2015 |
| NCT01941550 | Neoadjuvant cabazitaxel | II (n = 35) | Progression free survival | August 2018 |
| NCT01308567 | Cabazitaxel versus docetaxel | III (n = 1170) | Overall survival | December 2017 |
| NCT01978873 | Early chemotherapy with curative intent | III (n = 400) | Overall survival | November 2019 |
| Supportive care | ||||
| NCT01649635 | G-CSF and antibiotic prophylaxis | II (n = 45) | Rate of ≥ 3 neutropenia | July 2015 |
G-CSF, granulocyte colony-stimulating factor; PSA, prostate-specific antigen.