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NCT01525602 · ClinicalTrials.gov registry record · Phase 1
Safety Study of PLX3397 and Paclitaxel in Patients With Advanced Solid Tumors
A Phase 1 study, sponsored by Daiichi Sankyo.
- Completed
- Registry status
- Phase 1
- Development phase
- 74
- Enrollment target
NCT01525602: Completed Phase 1 study, sponsored by Daiichi Sankyo.
NCT01525602 is a Phase 1 study that has completed, run by Daiichi Sankyo. The registered enrollment target is 74 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (23% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01525602, a Phase 1 study, has completed, sponsored by Daiichi Sankyo.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 74 participants
- Enrollment target
Study Summary
This was a 3-part study designed to explore the safety and tolerability of escalating doses of PLX3397 with weekly paclitaxel to establish a recommended Phase 2 dose (RP2D), to confirm RP2D in participants with advanced non-resectable solid tumors, and to determine the efficacy of PLX3397 600 mg twice daily (BID) administered in combination with weekly paclitaxel in participants with advanced, metastatic or non-resectable, platinum-resistant or -refractory epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer.
Primary Outcome
Treatment-emergent adverse events (TEAEs) reported by \>10% of all participants in Parts 1 and 2 are reported.
Interventions
- DRUG Paclitaxel
- DRUG PLX3397
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 74 participants |
| Start Date | 2012-05 |
| Est. Completion | 2018-02 |
| Phase | Phase 1 |
What the finished NCT01525602 record still lists
NCT01525602 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 74 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (23% higher).
The record links to 0 conditions, and to 2 interventions - of which Paclitaxel is the first listed.
NCT01525602 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01525602 about?
NCT01525602 is a clinical study titled "Safety Study of PLX3397 and Paclitaxel in Patients With Advanced Solid Tumors". This was a 3-part study designed to explore the safety and tolerability of escalating doses of PLX3397 with weekly paclitaxel to establish a recommended Phase 2 dose (RP2D), to confirm RP2D in participants with advanced non-resectable solid tumors, and to determine the efficacy of PLX3397 600 mg twi...
What is the current status of trial NCT01525602?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 74 participants. The study started on 2012-05. Estimated completion is 2018-02.
What interventions are being tested in trial NCT01525602?
The interventions under investigation include: Paclitaxel (DRUG), PLX3397 (DRUG).
Who is sponsoring clinical trial NCT01525602?
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 NCT01525602's enrollment target sits among peer trials
74 725th of 2000 higher than 1,269 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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