drugset / Trial / NCT03343977
Toxicity & Pharmacokinetics of 2 & 3-weekly Docetaxel in Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)
RandomizedParallel-groupOpen-labelTreatment
Summary
This study is designed to investigate the toxicity and pharmacokinetics (PK) of 2-weekly and 3-weekly docetaxel in metastatic hormone-sensitive prostate cancer (mHSPC). Also, a mechanism-based population pharmacokinetics/pharmacodynamics (PK/PD) model will be developed to provide a better understanding of the complex relationships between the drug exposure and toxicity profiles of docetaxel in mHSPC.
Timeline
- Start
- 2018-02-14
- Primary completion
- 2019-04-30
- Completion
- 2029-04-30
Outcome
Outcome not reported
Stopped: “Study withdrawn for technical reasons”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Docetaxel | Small molecule | 50 mg/m2 | Intravenous |
| Subject | Docetaxel | Small molecule | 75 mg/m2 | Intravenous |