drugset / Trial / NCT01594918
Phase I Cabazitaxel, Mitoxantrone, and Prednisone Metastatic Castration-Resistant Prostate Cancer
NaSingle-groupOpen-labelTreatment
Summary
The purpose of this study is to test the safety of cabazitaxel, mitoxantrone, and prednisone (CAMP) in combination at different dose levels and to determine the highest dose that does not cause bad side effects. The investigators want to find out what effects, good and/or bad, CAMP has on patients and their metastatic castration-resistant prostate cancer.
Timeline
- Start
- 2012-06
- Primary completion
- 2016-08
- Completion
- 2017-06-23
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cabazitaxel | Other / unclassified | 20 mg/m2 | Intravenous |
| Subject | Cabazitaxel | Other / unclassified | 25 mg/m2 | Intravenous |
| Subject | Mitoxantrone | Small molecule | 4 mg/m2 | Intravenous |
| Subject | Mitoxantrone | Small molecule | 6 mg/m2 | Intravenous |
| Subject | Mitoxantrone | Small molecule | 8 mg/m2 | Intravenous |
| Subject | Mitoxantrone | Small molecule | 10 mg/m2 | Intravenous |
| Subject | Mitoxantrone | Small molecule | 12 mg/m2 | Intravenous |
| Background | Pegfilgrastim | Protein / enzyme biologic | 6 mg | Subcutaneous |
| Background | Prednisone | Other / unclassified | 5 mg | Oral |