drugset / Trial / NCT00314782

Phase I Study of ZD4054 (Zibotentan) and Docetaxel in Patients With Metastatic HRPC

NCT00314782

Phase 1 Completed 44 enrolled AstraZeneca
RandomizedParallel-groupQuadruple-blindTreatment

Summary

Two-part, multi-center study design to establish a maximum tolerated dose (MTD) of ZD4054 in combination with docetaxel and to explore its safety, tolerability, pharmacokinetic (PK) profiles and clinical efficacy in patients with metastatic hormone-refractory prostate cancer (HRPC)

Timeline

Start
2006-03
Primary completion
2008-03
Completion
2009-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Zibotentan Small molecule 10 mg Oral
Subject Zibotentan Small molecule 15 mg Oral
Background Docetaxel Small molecule 75 mg/m2 Intravenous

Indications