drugset / Trial / NCT02144051

Phase I Open Label Dose Escalation Study to Investigate the Safety & Pharmacokinetics of AZD5312 in Patients With Androgen Receptor Tumors

NCT02144051

Phase 1 Completed 32 enrolled AstraZeneca
NaSingle-groupOpen-labelTreatment

Summary

This is a first time in man (FTIM), Phase I study to determine the Maximum Tolerated Dose, Recommended Phase 2 Dose, safety, tolerability and Pharmacokinetics of AZD5312. This is a multicentre study with sites in the United States and United Kingdom. Approximately 90 patients are expected to be enrolled in this study. The study involves two parts, Part A, Dose Escalation and Part B, Dose Expansion.

Timeline

Start
2014-05
Primary completion
2016-03
Completion
2016-03

Drugs

EvaluationDrugModalityDoseRoute
Subject AZD5312 Unknown Intravenous

Indications

No indication recorded.