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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 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.

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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

Sponsor

Threshold Pharmaceuticals

9 total trials

What the Registry Record Tells You About NCT00495144

The ClinicalTrials.gov registry entry for NCT00495144 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 129 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 3,114-participant average among 39 other Hypoxia trials with a reported enrollment target (96% lower). The listed sponsor is Threshold Pharmaceuticals, which has 9 total studies on file at ClinicalTrials.gov.

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 reports 7 study locations spanning 6 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.