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NCT02432274 · ClinicalTrials.gov registry record · Phase 1
Study of Lenvatinib in Children and Adolescents With Refractory or Relapsed Solid Malignancies and Young Adults With Osteosarcoma
A Phase 1 study, sponsored by Eisai Limited.
- Completed
- Registry status
- Phase 1
- Development phase
- 117
- Enrollment target
NCT02432274: Completed Phase 1 study, sponsored by Eisai Limited.
NCT02432274 is a Phase 1 study that has completed, run by Eisai Limited. The registered enrollment target is 117 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (95% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02432274, a Phase 1 study, has completed, sponsored by Eisai Limited.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 117 participants
- Enrollment target
Study Summary
This is a phase 1/2 study evaluating safety, tolerability, and efficacy of lenvatinib as single-agent, and in combination with chemotherapy (ifosfamide and etoposide) in children and adolescents with refractory or relapsed solid malignancies including differentiated thyroid carcinoma (single agent lenvatinib) and osteosarcoma (single agent and combination lenvatinib).
Primary Outcome
RD was defined as the dose that had a dose limiting toxicity (DLT) rate closest to the targeted 20% rate. DLT was an adverse drug reaction and was assessed according to common terminology criteria for adverse events (CTCAE) version (v) 4.03 defined as 1) Grade 4 neutropenia for greater than or equal to (\>=) 7 days, 2) Grade \>=3 thrombocytopenia with bleeding, or lasting greater than (\>) 7 days, 3) Grade \>=3 febrile neutropenia, 4) Next course of chemotherapy delayed for \>=7 days, 5) Grade \
Interventions
- DRUG Lenvatinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 117 participants |
| Start Date | 2014-12-29 |
| Est. Completion | 2022-07-20 |
| Phase | Phase 1 |
What the finished NCT02432274 record still lists
NCT02432274 is an interventional study that assigns participants to a tested intervention. The registered 117 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 (95% higher).
The record links to 0 conditions, and to 1 intervention - of which Lenvatinib is the first listed.
NCT02432274 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02432274 about?
NCT02432274 is a clinical study titled "Study of Lenvatinib in Children and Adolescents With Refractory or Relapsed Solid Malignancies and Young Adults With Osteosarcoma". This is a phase 1/2 study evaluating safety, tolerability, and efficacy of lenvatinib as single-agent, and in combination with chemotherapy (ifosfamide and etoposide) in children and adolescents with refractory or relapsed solid malignancies including differentiated thyroid carcinoma (single agent l...
What is the current status of trial NCT02432274?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 117 participants. The study started on 2014-12-29. Estimated completion is 2022-07-20.
What interventions are being tested in trial NCT02432274?
The interventions under investigation include: Lenvatinib (DRUG).
Who is sponsoring clinical trial NCT02432274?
This trial is sponsored by Eisai Limited, which has 4 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02432274's enrollment target sits among peer trials
117 499th of 2000 higher than 1,500 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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