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

NCT00495144 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 129

Last updated 2012-07-27

No results posted yet for this study

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

Interventions

DRUG

TH-302

Sponsors & Collaborators

  • Threshold Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Howard Burris, MD · SCRI Development Innovations, LLC

  • Glen Weiss, MD · Translational Drug Development

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-06-30
Primary Completion
2011-12-31
Completion
2012-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00495144 on ClinicalTrials.gov