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NCT00495144 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Hypoxia and Tumors, sponsored by Threshold Pharmaceuticals.

Completed
Registry status
Phase 1
Development phase
129
Enrollment target
7
Study locations

NCT00495144: Completed Phase 1 study of Hypoxia and Tumors, sponsored by Threshold Pharmaceuticals.

NCT00495144 is a Phase 1 study of Hypoxia and Tumors that has completed, run by Threshold Pharmaceuticals. The registered enrollment target is 129 participants, below the 3,114-participant average among 39 other Hypoxia trials with a reported enrollment target (96% lower). The trial reports 7 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00495144, a Phase 1 study of Hypoxia and Tumors, has completed, sponsored by Threshold Pharmaceuticals.

COMPLETED
Registry status
Phase 1
Development phase
129 participants
Enrollment target
7
Study locations

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 Studied

Interventions

  • DRUG TH-302

Study Locations (7)

Arizona

  • TGen Drug Development Services - Scottsdale
  • Mayo Clinic Arizona - Scottsdale

California

  • St. Mary's Medical Center - San Francisco

Indiana

  • Indiana University Simon Cancer Center - Indianapolis

Minnesota

  • Mayo Clinic Rochester - Rochester

Tennessee

  • Sarah Cannon Research Institute - Nashville

Texas

  • Mary Crowley Cancer Research Centers - Dallas

Trial Details

FieldValue
Enrollment Target 129 participants
Start Date 2007-06
Est. Completion 2012-06
Phase Phase 1
Threshold Pharmaceuticals

9 total trials

What the finished NCT00495144 record still lists

NCT00495144 is an interventional study that assigns participants to a tested intervention. The registered 129 participants enrollment target is mid-sized for trials with a published cap, below the 3,114-participant average among 39 other Hypoxia trials with a reported enrollment target (96% lower).

The record links to 2 conditions, with Hypoxia appearing as the primary indexed condition, and to 1 intervention - of which TH-302 is the first listed.

NCT00495144 lists 7 locations in 6 states (Arizona, California, Indiana).

Frequently Asked Questions

What is clinical trial NCT00495144 about?

NCT00495144 is a clinical study titled "A Phase I Study of the Safety, Pharmacokinetics, and Anti-Tumor Activity of TH-302 in Patients With Advanced Solid Tumors". 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 pharmac...

What is the current status of trial NCT00495144?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 129 participants. The study started on 2007-06. Estimated completion is 2012-06.

What conditions does trial NCT00495144 study?

This clinical trial studies the following conditions: Hypoxia, Tumors.

What interventions are being tested in trial NCT00495144?

The interventions under investigation include: TH-302 (DRUG).

Who is sponsoring clinical trial NCT00495144?

This trial is sponsored by Threshold Pharmaceuticals, which has 9 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00495144 being conducted?

This trial has 7 study locations across Arizona, California, Indiana, Minnesota, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Hypoxia

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT00495144's enrollment target sits among peer trials

129 9th of 39 higher than 31 of 39 other Hypoxia trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Hypoxia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00495144, the US trial registry maintained by the National Library of Medicine. NCT00495144 (mid enrollment · multi site footprint · completed) retrieved and formatted by PlainTrial, see methodology.