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NCT00272350 · ClinicalTrials.gov registry record · Phase 1
ZD6474 to Treat Advanced Brain Cancer in Patients
A Phase 1 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 1
- Development phase
- 83
- Enrollment target
NCT00272350: Completed Phase 1 study, sponsored by National Cancer Institute (NCI).
NCT00272350 is a Phase 1 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 83 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00272350, a Phase 1 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 83 participants
- Enrollment target
Study Summary
Background: In vivo experiments have documented the ability of ZD6474 to inhibit tumor growth in various preclinical tumor models. Given the pronounced neovasculature associated with malignant gliomas, and abundant published data demonstrating the dependence of glioma growth on the maintenance and proliferation of this neovasculature, ZD6474 represents a potentially promising new therapeutic approach to these otherwise refractory tumors. Thus, we now propose a phase I trial of ZD6474 in patients with recurrent and progressive low-grade gliomas who are on P450-inducing anti-epileptic drugs and a phase II trial for patients with recurrent gliomas not taking P450-inducing anti-epileptic drugs. Objective: Phase I - To establish the maximally tolerated dose of ZD6474 and to obtain preliminary information regarding the spectrum of toxicities of ZD6474, and to obtain pharmacokinetic data to patients taking EIAED. Phase I - To obtain preliminary information regarding potential anti-tumor activity of ZD6474 in patients taking EIAED. Phase II - To establish data regarding the anti-tumor activity of ZD6474 and to collect information regarding the spectrum of toxicities in patients not taking EIAEDs. Eligibility: Patients with histologically proven malignant primary gliomas will be eligible for this protocol. Additionally, patients with progressive low-grade gliomas and patients with infiltrative brain stem gliomas, diagnosed radiographically rather than by biopsy will also be eligible. Design: Phase I - Group B patients will be accrued to the formal dose-escalation phase I trial. Groups of patients with recurrent high-grade gliomas will be accrued to increasingly higher doses of ZD6474 until the MTD is established. Phase II - Patients will be treated at a dose of 300 mg day, every day, on a 4-week cycle.
Interventions
- DRUG Steroids
- DRUG ZD6474
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 83 participants |
| Start Date | 2005-12-29 |
| Est. Completion | 2014-02-27 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00272350
The ClinicalTrials.gov registry entry for NCT00272350 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 83 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Steroids is the first listed.
NCT00272350 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00272350 about?
NCT00272350 is a clinical study titled "ZD6474 to Treat Advanced Brain Cancer in Patients". Background: In vivo experiments have documented the ability of ZD6474 to inhibit tumor growth in various preclinical tumor models. Given the pronounced neovasculature associated with malignant gliomas, and abundant published data demonstrating the dependence of glioma growth on the maintenance and ...
What is the current status of trial NCT00272350?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 83 participants. The study started on 2005-12-29. Estimated completion is 2014-02-27.
What interventions are being tested in trial NCT00272350?
The interventions under investigation include: Steroids (DRUG), ZD6474 (DRUG).
Who is sponsoring clinical trial NCT00272350?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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