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NCT00405587 · ClinicalTrials.gov registry record · Phase 1
Safety Study of PLX4032 in Patients With Solid Tumors
A Phase 1 study, sponsored by Plexxikon.
- Completed
- Registry status
- Phase 1
- Development phase
- 109
- Enrollment target
NCT00405587: Completed Phase 1 study, sponsored by Plexxikon.
NCT00405587 is a Phase 1 study that has completed, run by Plexxikon. The registered enrollment target is 109 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (82% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00405587, a Phase 1 study, has completed, sponsored by Plexxikon.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 109 participants
- Enrollment target
Study Summary
The primary objective of this FIH study is to assess the safety and pharmacokinetics of PLX4032 in patients with solid tumors. The secondary objective is to assess the pharmacodynamic activity in paired biopsy specimens obtained from patients with malignant melanoma who have the V600E BRAF oncogenic mutation.
Primary Outcome
AUC (0-8 hour) was defined as the area under the plasma concentration-time curve from time equals zero (0) to 8 hours post-dose. AUC (0-24 hour) was defined as the area under the plasma concentration-time curve from time equals 0 to 24 hours post-dose. AUC (0-8 hour) and AUC (0-24 hour) were computed using the linear trapezoidal rule.
Interventions
- DRUG PLX4032
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 109 participants |
| Start Date | 2006-11 |
| Est. Completion | 2016-02 |
| Phase | Phase 1 |
What the finished NCT00405587 record still lists
NCT00405587 is an interventional study that assigns participants to a tested intervention. The registered 109 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 (82% higher).
The record links to 0 conditions, and to 1 intervention - of which PLX4032 is the first listed.
NCT00405587 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00405587 about?
NCT00405587 is a clinical study titled "Safety Study of PLX4032 in Patients With Solid Tumors". The primary objective of this FIH study is to assess the safety and pharmacokinetics of PLX4032 in patients with solid tumors. The secondary objective is to assess the pharmacodynamic activity in paired biopsy specimens obtained from patients with malignant melanoma who have the V600E BRAF oncogenic...
What is the current status of trial NCT00405587?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 109 participants. The study started on 2006-11. Estimated completion is 2016-02.
What interventions are being tested in trial NCT00405587?
The interventions under investigation include: PLX4032 (DRUG).
Who is sponsoring clinical trial NCT00405587?
This trial is sponsored by Plexxikon, which has 6 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00405587's enrollment target sits among peer trials
109 522nd of 2000 higher than 1,478 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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