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NCT00106353 · ClinicalTrials.gov registry record · Phase 1
Study Evaluating Biomarkers In Relapsed/Refractory Pediatric Solid Tumors
A Phase 1 study, sponsored by Pfizer.
- Completed
- Registry status
- Phase 1
- Development phase
- 71
- Enrollment target
NCT00106353: Completed Phase 1 study, sponsored by Pfizer.
NCT00106353 is a Phase 1 study that has completed, run by Pfizer. The registered enrollment target is 71 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (18% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00106353, a Phase 1 study, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 71 participants
- Enrollment target
Study Summary
This is an open label, two-part study of temsirolimus given as a 60-minute intravenous (IV) infusion once weekly to pediatric subjects with advanced solid tumors. Part 1 is an ascending-dose study to evaluate the safety of IV temsirolimus given once weekly to subjects ages 1 to 21 years with advanced solid tumors disease that is recurrent or refractory to standard therapy or for whom standard therapy is not available. (enrollment completed) Part 2 will be conducted in three groups of children with refractory or relapsed pediatric solid tumors. Subjects with the following tumor types will be enrolled: neuroblastoma, rhabdomyosarcoma, and high-grade gliomas. Subjects will receive IV temsirolimus once weekly until disease progression or unacceptable toxicity. (recruiting)
Primary Outcome
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Interventions
- DRUG Torisel
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 71 participants |
| Start Date | 2005-03 |
| Est. Completion | 2012-01 |
| Phase | Phase 1 |
What the finished NCT00106353 record still lists
NCT00106353 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 71 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (18% higher).
The record links to 0 conditions, and to 1 intervention - of which Torisel is the first listed.
NCT00106353 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00106353 about?
NCT00106353 is a clinical study titled "Study Evaluating Biomarkers In Relapsed/Refractory Pediatric Solid Tumors". This is an open label, two-part study of temsirolimus given as a 60-minute intravenous (IV) infusion once weekly to pediatric subjects with advanced solid tumors. Part 1 is an ascending-dose study to evaluate the safety of IV temsirolimus given once weekly to subjects ages 1 to 21 years with advanc...
What is the current status of trial NCT00106353?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 71 participants. The study started on 2005-03. Estimated completion is 2012-01.
What interventions are being tested in trial NCT00106353?
The interventions under investigation include: Torisel (DRUG).
Who is sponsoring clinical trial NCT00106353?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00106353's enrollment target sits among peer trials
71 747th of 2000 higher than 1,252 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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