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COMPLETED Phase 1

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

NCT00495144 · View on ClinicalTrials.gov ↗

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

2 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00495144

The ClinicalTrials.gov registry entry for NCT00495144 describes a study currently listed as completed. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 129 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Threshold Pharmaceuticals, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT00495144 reports 7 study locations spanning 6 distinct geographic areas — top geographies include Arizona, California, Indiana. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00495144?

The interventions under investigation include: TH-302 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00495144?

This trial is sponsored by Threshold Pharmaceuticals, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

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