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Completed Phase 1 Interventional

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

ClinicalTrials.gov ID: NCT00495144

Public ClinicalTrials.gov record NCT00495144. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 2, 2026, 11:45 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT00495144
Recruitment status
Completed
Study type
Interventional
Phase
Phase 1
Lead sponsor
Threshold Pharmaceuticals
Industry
Enrollment
129 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
May 31, 2007
Primary completion
Nov 30, 2011
Completion
May 31, 2012
Last update posted
Jul 26, 2012

2007 – 2012

United States locations

U.S. sites
7
U.S. states
6
U.S. cities
6
Facility City State ZIP Site status
TGen Drug Development Services Scottsdale Arizona 85258
Mayo Clinic Arizona Scottsdale Arizona 85259
St. Mary's Medical Center San Francisco California 94117
Indiana University Simon Cancer Center Indianapolis Indiana 46202
Mayo Clinic Rochester Rochester Minnesota 55905
Sarah Cannon Research Institute Nashville Tennessee 37203
Mary Crowley Cancer Research Centers Dallas Texas 75201

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00495144, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jul 26, 2012 · Synced Sep 2, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00495144 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →