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COMPLETED Phase 2

Ph. 2 Sorafenib + Protracted Temozolomide in Recurrent GBM

NCT00597493 · View on ClinicalTrials.gov ↗

Study Summary

PURPOSE AND OBJECTIVES: Primary Objective To evaluate the activity of Sorafenib plus protracted, daily temozolomide in patients with recurrent glioblastoma multiforme (GBM) as measured by 6-month PFS. Secondary Objectives To evaluate the safety and toxicity of combination therapy using Sorafenib plus temozolomide; To determine the pharmacokinetics of Sorafenib when combined with temozolomide in patients on and not on concurrent EIAC medications.

Interventions

  • DRUG Sorafenib and Temozolomide

Study Locations (1)

North Carolina

  • Duke University Health System — Durham

Trial Details

FieldValue
Enrollment Target 32 participants
Start Date 2007-09
Est. Completion 2010-12
Phase Phase 2

Sponsor

Duke University

1,129 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00597493

The ClinicalTrials.gov registry entry for NCT00597493 describes a study currently listed as completed. It is categorized as Phase 2, 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 32 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Duke University, which has 1,129 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Recurrent Glioblastoma Multiforme appearing as the primary indexed condition, and to 1 intervention — of which Sorafenib and Temozolomide 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: NCT00597493 reports 1 study location spanning 1 distinct geographic area — top geographies include North Carolina. 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 NCT00597493 about?

NCT00597493 is a clinical study titled "Ph. 2 Sorafenib + Protracted Temozolomide in Recurrent GBM". PURPOSE AND OBJECTIVES: Primary Objective To evaluate the activity of Sorafenib plus protracted, daily temozolomide in patients with recurrent glioblastoma multiforme (GBM) as measured by 6-month PFS. Secondary Objectives To evaluate the safety and toxicity of combination therapy using Sorafenib p...

What is the current status of trial NCT00597493?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 32 participants. The study started on 2007-09. Estimated completion is 2010-12.

What conditions does trial NCT00597493 study?

This clinical trial studies the following conditions: Recurrent Glioblastoma Multiforme. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00597493?

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

Who is sponsoring clinical trial NCT00597493?

This trial is sponsored by Duke University, which has 1,129 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT00597493 being conducted?

This trial has 1 study location across North Carolina. 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