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NCT00658658 · ClinicalTrials.gov registry record · Phase 1
Panitumumab in Children With Solid Tumors
A Phase 1 study, sponsored by Amgen.
- Completed
- Registry status
- Phase 1
- Development phase
- 31
- Enrollment target
NCT00658658: Completed Phase 1 study, sponsored by Amgen.
NCT00658658 is a Phase 1 study that has completed, run by Amgen. The registered enrollment target is 31 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (48% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00658658, a Phase 1 study, has completed, sponsored by Amgen.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 31 participants
- Enrollment target
Study Summary
The primary objective of this study was to evaluate the safety and pharmacokinetics of up to 3 different dose schedules of panitumumab in pediatric patients with solid tumors.
Primary Outcome
Any panitumumab related grade 3 or 4 hematologic or non-hematologic toxicity (graded according to the modified Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 criteria) was considered a DLT with the exception of alopecia and fatigue. Hypomagnesemia, nausea, diarrhea, vomiting, and skin or nail toxicities constituted a DLT only of the following occured: • Grade 3 or 4 hypomagnesemia that persisted for at least 5 days despite maximal magnesium replacement; • Grade 3 or 4 diarrhe
Interventions
- BIOLOGICAL Panitumumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2008-03 |
| Est. Completion | 2015-03 |
| Phase | Phase 1 |
What the finished NCT00658658 record still lists
NCT00658658 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 31 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (48% lower).
The record links to 0 conditions, and to 1 intervention - of which Panitumumab is the first listed.
NCT00658658 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00658658 about?
NCT00658658 is a clinical study titled "Panitumumab in Children With Solid Tumors". The primary objective of this study was to evaluate the safety and pharmacokinetics of up to 3 different dose schedules of panitumumab in pediatric patients with solid tumors.
What is the current status of trial NCT00658658?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 31 participants. The study started on 2008-03. Estimated completion is 2015-03.
What interventions are being tested in trial NCT00658658?
The interventions under investigation include: Panitumumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT00658658?
This trial is sponsored by Amgen, which has 558 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00658658's enrollment target sits among peer trials
31 1322nd of 2000 higher than 669 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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