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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 is a Phase 1 study that has completed, run by Daiichi Sankyo. The registered enrollment target is 132 participants.

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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.

Interventions

  • DRUG PLX3397

Trial Details

FieldValue
Enrollment Target 132 participants
Start Date 2009-10-01
Est. Completion 2018-10-25
Phase Phase 1

Sponsor

Daiichi Sankyo

236 total trials

What the Registry Record Tells You About NCT01004861

The ClinicalTrials.gov registry entry for NCT01004861 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 132 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Daiichi Sankyo, which has 236 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which PLX3397 is the first listed.

NCT01004861 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.