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NCT00441142 · ClinicalTrials.gov registry record · Phase 1
Zactima With Temodar During Radiation Treatment for Newly Diagnosed Stage IV Brain Tumors
A Phase 1 study, sponsored by Patrick Y. Wen, MD.
- Completed
- Registry status
- Phase 1
- Development phase
- 119
- Enrollment target
NCT00441142: Completed Phase 1 study, sponsored by Patrick Y. Wen, MD.
NCT00441142 is a Phase 1 study that has completed, run by Patrick Y. Wen, MD. The registered enrollment target is 119 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (98% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00441142, a Phase 1 study, has completed, sponsored by Patrick Y. Wen, MD.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 119 participants
- Enrollment target
Study Summary
Phase I: The purpose of this research study is to determine the safety of the combination treatment of ZD6474 (Vandetanib) with the standard therapy for glioblastomas and gliosarcomas, temozolomide (Temodar) and radiation therapy. This agent is investigational for the treatment of glioblastomas. We will determine the highest dose of ZD6474 (Vandetanib) that can be given safely when combined with temozolomide (Temodar) and radiation therapy. Phase II: The purpose of this research study is to determine the efficacy of the combination treatment of ZD6474 (Vandetanib) with the standard therapy for glioblastomas and gliosarcomas, temozolomide (Temodar) and radiation therapy. This agent is investigational for the treatment of glioblastomas. All subjects participating in this research study must NOT be taking a certain type of anti-seizure medication called enzyme inducing anticonvulsant drugs. These drugs include (but are not limited to) the following medications: Dilantin, Tegretol, Phenobarbital and trileptal.
Primary Outcome
The primary outcome of Phase I of this trial was to determine the maximum tolerated dose (MTD) of ZD6474 (Vandetanib) in patients with newly-diagnosed glioblastomas multiforme (GBM) and gliosarcomas who are also receiving radiation therapy with concomitant and adjuvant temozolomide. The MTD is the dose level at which 0/6 or 1/6 patients experience a dose-limiting toxicity (DLT) with the next higher dose having at least 2/3 or 2/6 patients encountering DLT.
Interventions
- RADIATION Radiation Therapy
- DRUG temozolomide
- DRUG ZD6474
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 119 participants |
| Start Date | 2007-05-25 |
| Est. Completion | 2017-10-10 |
| Phase | Phase 1 |
What the finished NCT00441142 record still lists
NCT00441142 is an interventional study that assigns participants to a tested intervention. The registered 119 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (98% higher).
The record links to 0 conditions, and to 3 interventions - of which Radiation Therapy is the first listed.
NCT00441142 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00441142 about?
NCT00441142 is a clinical study titled "Zactima With Temodar During Radiation Treatment for Newly Diagnosed Stage IV Brain Tumors". Phase I: The purpose of this research study is to determine the safety of the combination treatment of ZD6474 (Vandetanib) with the standard therapy for glioblastomas and gliosarcomas, temozolomide (Temodar) and radiation therapy. This agent is investigational for the treatment of glioblastomas. We...
What is the current status of trial NCT00441142?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 119 participants. The study started on 2007-05-25. Estimated completion is 2017-10-10.
What interventions are being tested in trial NCT00441142?
The interventions under investigation include: Radiation Therapy (RADIATION), temozolomide (DRUG), ZD6474 (DRUG).
Who is sponsoring clinical trial NCT00441142?
This trial is sponsored by Patrick Y. Wen, MD, which has 7 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00441142's enrollment target sits among peer trials
119 498th of 2000 higher than 1,502 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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