NCT00495144

A Phase I Study of the Safety, Pharmacokinetics, and Anti-Tumor Activity of TH-302 in Patients With Advanced Solid Tumors

A Phase I, Multi-Center, Open-Label, Dose-Escalation Study of the Safety, Pharmacokinetics and Anti-Tumor Activity of TH-302 in Patients With Advanced Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 129 (actual)
• Sponsor: Threshold Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a phase I, multi-center, open-label, dose-escalation study of TH-302 in patients with advanced solid tumors. TH-302 is a hypoxia activated product designed to exploit the hypoxic nature of tumors. The study is designed to establish the safety including the maximum tolerated dose, the pharmacokinetics, and the anti-tumor activity of TH-302.

Conditions

• Tumors
• Hypoxia

Interventions

Type	Name	Description
DRUG	TH-302

Timeline

• Start date: 2007-06-01
• Primary completion: 2011-12-01
• Completion: 2012-06-01
• First posted: 2007-07-02
• Last updated: 2012-07-27

Locations

7 sites across 1 country: United States