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NCT00533169 · ClinicalTrials.gov registry record · Phase 1
ZD6474 Alone and in Combination With Retinoic Acid in Pediatric Neuroblastoma
A Phase 1 study, sponsored by M.D. Anderson Cancer Center.
- Terminated
- Registry status
- Phase 1
- Development phase
- 10
- Enrollment target
NCT00533169: Clinical Trial Phase 1 study, sponsored by M.D. Anderson Cancer Center.
NCT00533169 is a Phase 1 study that was terminated before completion, run by M.D. Anderson Cancer Center. The registered enrollment target is 10 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00533169, a Phase 1 study, was terminated before completion, sponsored by M.D. Anderson Cancer Center.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 10 participants
- Enrollment target
Study Summary
The goal of this clinical research study is to find the highest safe dose of the drug ZactimaTM (ZD6474) in patients with neuroblastoma or medulloblastoma that has gotten worse, has come back, or has not responded to the treatment. Primary Objective: -To determine the pharmacokinetics, safety, dose-limiting toxicities, and maximum tolerated dose of ZD6474, alone in children with medulloblastoma, and alone in combination with retinoic acid, in patients with relapsed or refractory neuroblastoma. Secondary Objective: -To assess progression-free survival (PFS) and objective tumor response rates in children with relapsed and refractory neuroblastoma and medulloblastoma treated with ZD6474 +/- retinoic acid in the context of a Phase I trial.
Primary Outcome
MTD is highest dose level in which 6 participants have been treated with at most 2 experiencing dose limiting toxicity (DLT).
Interventions
- DRUG ZD6474
- DRUG Retinoic Acid
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2007-09 |
| Est. Completion | 2011-02 |
| Phase | Phase 1 |
Why NCT00533169 stopped before completion
NCT00533169 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (83% lower).
The record links to 0 conditions, and to 2 interventions - of which ZD6474 is the first listed.
NCT00533169 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00533169 about?
NCT00533169 is a clinical study titled "ZD6474 Alone and in Combination With Retinoic Acid in Pediatric Neuroblastoma". The goal of this clinical research study is to find the highest safe dose of the drug ZactimaTM (ZD6474) in patients with neuroblastoma or medulloblastoma that has gotten worse, has come back, or has not responded to the treatment. Primary Objective: -To determine the pharmacokinetics, safety, dos...
What is the current status of trial NCT00533169?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 10 participants. The study started on 2007-09. Estimated completion is 2011-02.
What interventions are being tested in trial NCT00533169?
The interventions under investigation include: ZD6474 (DRUG), Retinoic Acid (DRUG).
Who is sponsoring clinical trial NCT00533169?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00533169's enrollment target sits among peer trials
10 1913th of 2000 higher than 46 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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