drugset / Trial / NCT03343977

Toxicity & Pharmacokinetics of 2 & 3-weekly Docetaxel in Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)

NCT03343977 ↗

Phase 1/2 Withdrawn Peng Wang, MD PhD
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Stopped: “Study withdrawn for technical reasons”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

EvaluationDrugModalityDoseRoute
Subject Docetaxel Small molecule 50 mg/m2 Intravenous
Subject Docetaxel Small molecule 75 mg/m2 Intravenous

Indications