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COMPLETED Phase 1

Study of Lenvatinib in Combination With Everolimus in Recurrent and Refractory Pediatric Solid Tumors, Including Central Nervous System Tumors

NCT03245151 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 64 participants
Start Date 2017-11-16
Est. Completion 2022-09-30
Phase Phase 1

Sponsor

Eisai

71 total trials

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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. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. 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 71 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT03245151 reports 20 study locations spanning 12 distinct geographic areas — top geographies include California, Florida, Alabama. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT03245151?

The interventions under investigation include: Everolimus (DRUG), Lenvatinib (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03245151?

This trial is sponsored by Eisai, which has 71 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

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