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NCT01004861 · ClinicalTrials.gov registry record · Phase 1
Safety Study of PLX108-01 in Patients With Solid Tumors
A Phase 1 study, sponsored by Daiichi Sankyo.
- Completed
- Registry status
- Phase 1
- Development phase
- 132
- Enrollment target
NCT01004861: Completed Phase 1 study, sponsored by Daiichi Sankyo.
NCT01004861 is a Phase 1 study that has completed, run by Daiichi Sankyo. The registered enrollment target is 132 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (120% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01004861, a Phase 1 study, has completed, sponsored by Daiichi Sankyo.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 132 participants
- Enrollment target
Study Summary
PLX3397 is a selective inhibitor of Fms, Kit, and oncogenic Flt3 activity. The primary objective of this study is to evaluate the safety and pharmacokinetics of orally administered PLX3397 in patients with advanced, incurable, solid tumors in which these target kinases are linked to disease pathophysiology. The secondary objective is to measure the pharmacodynamic activity of PLX3397 via blood, plasma and urine biomarkers of Fms activity.
Primary Outcome
Best overall tumor response (complete response \[CR\], partial response \[PR\], stable disease \[SD\], progressive disease \[PD\]) is reported, including participants who were not evaluable (NE). RECIST v1.1 for target lesions are assessed by magnetic resonance imaging, computed tomography, or positron emission tomography-computed tomography and are summarized as: CR, Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to \<10 mm; PR, At least a 3
Interventions
- DRUG PLX3397
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 132 participants |
| Start Date | 2009-10-01 |
| Est. Completion | 2018-10-25 |
| Phase | Phase 1 |
What the finished NCT01004861 record still lists
NCT01004861 is an interventional study that assigns participants to a tested intervention. The registered 132 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 (120% higher).
The record links to 0 conditions, and to 1 intervention - of which PLX3397 is the first listed.
NCT01004861 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01004861 about?
NCT01004861 is a clinical study titled "Safety Study of PLX108-01 in Patients With Solid Tumors". PLX3397 is a selective inhibitor of Fms, Kit, and oncogenic Flt3 activity. The primary objective of this study is to evaluate the safety and pharmacokinetics of orally administered PLX3397 in patients with advanced, incurable, solid tumors in which these target kinases are linked to disease pathophy...
What is the current status of trial NCT01004861?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 132 participants. The study started on 2009-10-01. Estimated completion is 2018-10-25.
What interventions are being tested in trial NCT01004861?
The interventions under investigation include: PLX3397 (DRUG).
Who is sponsoring clinical trial NCT01004861?
This trial is sponsored by Daiichi Sankyo, which has 236 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01004861's enrollment target sits among peer trials
132 432nd of 2000 higher than 1,562 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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