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NCT01396148 · ClinicalTrials.gov registry record · Phase 2
A Study of Sunitinib In Young Patients With Advanced Gastrointestinal Stromal Tumor
A Phase 2 study, sponsored by Pfizer.
- Completed
- Registry status
- Phase 2
- Development phase
- 6
- Enrollment target
NCT01396148: Completed Phase 2 study, sponsored by Pfizer.
NCT01396148 is a Phase 2 study that has completed, run by Pfizer. The registered enrollment target is 6 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01396148, a Phase 2 study, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 6 participants
- Enrollment target
Study Summary
Children and young adults with gastrointestinal stromal tumors (GIST) will be treated with sunitinib. The safety (including pharmacokinetics) and tolerability of sunitinib will be studied in these patients. In addition, tumor responses and overall survival will be assessed.
Primary Outcome
Estimated steady-state maximum plasma concentration (Cmax,ss) of Sunitinib and its metabolite SU012662. Summarized data for all time points was reported.
Interventions
- DRUG sunitinib malate
- DRUG sunitinib malate dose escalation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2012-06 |
| Est. Completion | 2017-08 |
| Phase | Phase 2 |
What the finished NCT01396148 record still lists
NCT01396148 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 2 interventions - of which sunitinib malate is the first listed.
NCT01396148 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01396148 about?
NCT01396148 is a clinical study titled "A Study of Sunitinib In Young Patients With Advanced Gastrointestinal Stromal Tumor". Children and young adults with gastrointestinal stromal tumors (GIST) will be treated with sunitinib. The safety (including pharmacokinetics) and tolerability of sunitinib will be studied in these patients. In addition, tumor responses and overall survival will be assessed.
What is the current status of trial NCT01396148?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 6 participants. The study started on 2012-06. Estimated completion is 2017-08.
What interventions are being tested in trial NCT01396148?
The interventions under investigation include: sunitinib malate (DRUG), sunitinib malate dose escalation (DRUG).
Who is sponsoring clinical trial NCT01396148?
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 NCT01396148's enrollment target sits among peer trials
6 1996th of 2000 higher than 1 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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