drugset / Trial / NCT02020226

A Cardiac Safety Study of TH-302 in Patients With Advanced Solid Tumors

NCT02020226

Phase 1 Unknown 40 enrolled Threshold Pharmaceuticals
NaSingle-groupOpen-labelTreatment

Summary

The Primary objective of this study is: 1\. To determine the cardiac safety of TH-302 in patients with advanced solid tumors The Secondary objectives are: 1. To assess the pharmacokinetics (PK) of TH-302 2. To evaluate whether there is an association between plasma exposure to TH-302 and its active metabolite, Br-IPM, and effects on cardiac repolarization 3. To assess the safety and antitumor activity of TH-302 in patients with advanced solid tumors

Timeline

Start
2013-11
Primary completion
2016-07
Completion
2016-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Evofosfamide Other / unclassified 480 mg/m2 Intravenous

Indications