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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 is a Phase 1 study of Recurrent and Refractory Solid Tumors that has completed, run by Eisai. The registered enrollment target is 64 participants. The trial reports 20 study locations across 12 states.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03245151
The ClinicalTrials.gov registry entry for NCT03245151 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 64 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 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 reports 20 study locations spanning 12 distinct geographic areas - top geographies include 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.
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