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NCT02171260 · ClinicalTrials.gov registry record · Phase 1
This is a Phase 1 Study of Eribulin Mesylate in Pediatric Participants With Recurrent or Refractory Solid Tumors (Excluding [Central Nervous System] CNS), Including Lymphomas
A Phase 1 study, sponsored by Eisai.
- Completed
- Registry status
- Phase 1
- Development phase
- 23
- Enrollment target
NCT02171260 is a Phase 1 study that has completed, run by Eisai. The registered enrollment target is 23 participants.
The verdict
NCT02171260, a Phase 1 study, has completed, sponsored by Eisai.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 23 participants
- Enrollment target
Study Summary
This is a Phase 1 study of eribulin mesylate in pediatric participants with recurrent or refractory solid tumors (excluding CNS), including lymphomas. Eribulin mesylate will be administered intravenously, once per day on Days 1 and 8 of a 21-day cycle. This study aims to determine the maximum tolerated dose (MTD) and/or the Recommended Phase 2 Dose (RP2D) of this regimen in Part A1 (participants greater than or equal to \[\>=\] 12 months and less than \[\<\] 18 years). Part A2 will enroll infants (greater than \[\>\] 6 months and \<12 months) one dose level behind the dose level at which participants in Part A1 are enrolling, in order to maximize safety for infant participants. Additionally, this study aims to describe the toxicities and the pharmacokinetics of eribulin mesylate when administered to children. In a preliminary manner, the antitumor effect of eribulin mesylate will also be described.
Interventions
- DRUG Eribulin Mesylate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 2014-07-31 |
| Est. Completion | 2016-01-28 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02171260
The ClinicalTrials.gov registry entry for NCT02171260 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 23 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Eisai, which has 287 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Eribulin Mesylate is the first listed.
NCT02171260 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02171260 about?
NCT02171260 is a clinical study titled "This is a Phase 1 Study of Eribulin Mesylate in Pediatric Participants With Recurrent or Refractory Solid Tumors (Excluding [Central Nervous System] CNS), Including Lymphomas". This is a Phase 1 study of eribulin mesylate in pediatric participants with recurrent or refractory solid tumors (excluding CNS), including lymphomas. Eribulin mesylate will be administered intravenously, once per day on Days 1 and 8 of a 21-day cycle. This study aims to determine the maximum tolera...
What is the current status of trial NCT02171260?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 23 participants. The study started on 2014-07-31. Estimated completion is 2016-01-28.
What interventions are being tested in trial NCT02171260?
The interventions under investigation include: Eribulin Mesylate (DRUG).
Who is sponsoring clinical trial NCT02171260?
This trial is sponsored by Eisai, which has 287 total clinical trials registered on ClinicalTrials.gov.
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