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NCT03245151 · ClinicalTrials.gov registry record · Phase 1
Study of Lenvatinib in Combination With Everolimus in Recurrent and Refractory Pediatric Solid Tumors, Including Central Nervous System Tumors
A Phase 1 study of Recurrent and Refractory Solid Tumors, sponsored by Eisai.
- Completed
- Registry status
- Phase 1
- Development phase
- 64
- Enrollment target
- 20
- Study locations
NCT03245151: Completed Phase 1 study of Recurrent and Refractory Solid Tumors, sponsored by Eisai.
NCT03245151 is a Phase 1 study of Recurrent and Refractory Solid Tumors that has completed, run by Eisai. The registered enrollment target is 64 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03245151, a Phase 1 study of Recurrent and Refractory Solid Tumors, has completed, sponsored by Eisai.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 64 participants
- Enrollment target
- 20
- Study locations
Study Summary
Phase 1 of this study, utilizing a rolling 6 design, will be conducted to determine a maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D), and to describe the toxicities of lenvatinib administered in combination with everolimus once daily to pediatric participants with recurrent/refractory solid tumors. Phase 2, utilizing Simon's optimal 2-stage design, will be conducted to estimate the antitumor activity of lenvatinib in combination with everolimus in pediatric participants with selected recurrent/refractory solid tumors including Ewing sarcoma, rhabdomyosarcoma, and high grade glioma (HGG) using objective response rate (ORR) at Week 16 as the outcome measure.
Primary Outcome
MTD was defined as the highest dose level at which no more than 1/6 participants experienced a dose limiting toxicity (DLTs), with the next higher dose having at least 0 of 3 or 1 of 6 participants experiencing DLTs. DLT was graded according to common terminology criteria for adverse events (CTCAE) version 4.03.
Conditions Studied
Interventions
- DRUG Everolimus
- DRUG Lenvatinib
Study Locations (20)
California
- Loma Linda University Medical Center - Loma Linda
- Miller Children's and Women's Hospital - Long Beach
- Children's Hospital of Los Angeles - Los Angeles
- Southern California Permanente Medical Group - Los Angeles
- Kaiser Permenente - Oakland
- Children's Hospital of Orange County - Orange
- UCSF Medical Center at Mission Bay - Pediatric Oncology - San Francisco
Florida
- Golisano Children's Hospital of Southwest Florida - Fort Myers
- University of Florida - Gainesville
- Nicklaus Children's Hospital - Miami
Alabama
- Children's Hospital of Alabama - Birmingham
Arizona
- Phoenix Children's Hospital - Phoenix
Colorado
- Children's Hospital Colorado - Aurora
Delaware
- Nemours/ Alfred I. duPont Hospital for Children - Wilmington
District of Columbia
- Children's National Medical Center - Washington D.C.
Hawaii
- Kapi'olani Medical Center - Honolulu
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 64 participants |
| Start Date | 2017-11-16 |
| Est. Completion | 2022-09-30 |
| Phase | Phase 1 |
What the finished NCT03245151 record still lists
NCT03245151 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 64 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.
The record links to 1 condition, with Recurrent and Refractory Solid Tumors appearing as the primary indexed condition, and to 2 interventions - of which Everolimus is the first listed.
NCT03245151 names 20 study sites across 12 states, led by California, Florida, Alabama.
Frequently Asked Questions
What is clinical trial NCT03245151 about?
NCT03245151 is a clinical study titled "Study of Lenvatinib in Combination With Everolimus in Recurrent and Refractory Pediatric Solid Tumors, Including Central Nervous System Tumors". Phase 1 of this study, utilizing a rolling 6 design, will be conducted to determine a maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D), and to describe the toxicities of lenvatinib administered in combination with everolimus once daily to pediatric participants with recurrent/refract...
What is the current status of trial NCT03245151?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 64 participants. The study started on 2017-11-16. Estimated completion is 2022-09-30.
What conditions does trial NCT03245151 study?
This clinical trial studies the following conditions: Recurrent and Refractory Solid Tumors.
What interventions are being tested in trial NCT03245151?
The interventions under investigation include: Everolimus (DRUG), Lenvatinib (DRUG).
Who is sponsoring clinical trial NCT03245151?
This trial is sponsored by Eisai, which has 287 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03245151 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Colorado, Delaware. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03245151's enrollment target sits among peer trials
64 808th of 2000 higher than 1,181 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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