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NCT01499043 · ClinicalTrials.gov registry record · Phase 2
Pilot Study of PLX3397 in Patients With Advanced Castration-Resistant Prostate Cancer (CRPC)
A Phase 2 study, sponsored by Daiichi Sankyo.
- Terminated
- Registry status
- Phase 2
- Development phase
- 6
- Enrollment target
NCT01499043: Clinical Trial Phase 2 study, sponsored by Daiichi Sankyo.
NCT01499043 is a Phase 2 study that was terminated before completion, run by Daiichi Sankyo. 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
NCT01499043, a Phase 2 study, was terminated before completion, sponsored by Daiichi Sankyo.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 6 participants
- Enrollment target
Study Summary
The main objective of this study is to evaluate the effects of PLX3397 on male subjects with CRPC. Secondary objectives include evaluating the safety and tolerability of PLX3397 and the anti-tumor effects that PLX3397 has on the the subjects.
Primary Outcome
Effects of PLX3397 on CTC number in men with radiographically progressive CRPC and high CTC counts (≥10 CTCs/7.5 mL of blood using CellSearch Assay) CTC counts were to be evaluated at the following time points: Screening, Baseline, every 4 weeks after treatment initiation, and at Safety Follow-up. Radiographic tumor evaluation were to be performed every 8 weeks. Progression at the first reassessment required a confirmatory scan at a minimum of 6 weeks later, and treatment with study medication
Interventions
- DRUG PLX3397
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2012-05-25 |
| Est. Completion | 2013-03-11 |
| Phase | Phase 2 |
Why NCT01499043 stopped before completion
NCT01499043 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 1 intervention - of which PLX3397 is the first listed.
NCT01499043 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01499043 about?
NCT01499043 is a clinical study titled "Pilot Study of PLX3397 in Patients With Advanced Castration-Resistant Prostate Cancer (CRPC)". The main objective of this study is to evaluate the effects of PLX3397 on male subjects with CRPC. Secondary objectives include evaluating the safety and tolerability of PLX3397 and the anti-tumor effects that PLX3397 has on the the subjects.
What is the current status of trial NCT01499043?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 6 participants. The study started on 2012-05-25. Estimated completion is 2013-03-11.
What interventions are being tested in trial NCT01499043?
The interventions under investigation include: PLX3397 (DRUG).
Who is sponsoring clinical trial NCT01499043?
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 NCT01499043'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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