Study of Lenvatinib in Combination With Everolimus in Recurrent and Refractory Pediatric Solid Tumors, Including Central Nervous System Tumors
Public ClinicalTrials.gov record NCT03245151. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 1/2 Study of Lenvatinib in Combination With Everolimus in Recurrent and Refractory Pediatric Solid Tumors, Including CNS Tumors
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT03245151
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 64 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 2 Years to 21 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 16, 2017 (Actual)
- Primary completion
- Sep 30, 2022 (Actual)
- Completion
- Sep 30, 2022 (Actual)
- Last update posted
- Aug 30, 2023
2017 – 2022
United States locations
- U.S. sites
- 47
- U.S. states
- 28
- U.S. cities
- 45
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Children's Hospital of Alabama | Birmingham | Alabama | 35233 | — |
| Phoenix Children's Hospital | Phoenix | Arizona | 85016 | — |
| Loma Linda University Medical Center | Loma Linda | California | 92350 | — |
| Miller Children's and Women's Hospital | Long Beach | California | 90806 | — |
| Children's Hospital of Los Angeles | Los Angeles | California | 90027 | — |
| Southern California Permanente Medical Group | Los Angeles | California | 90027 | — |
| Kaiser Permenente | Oakland | California | 94611 | — |
| Children's Hospital of Orange County | Orange | California | 92868 | — |
| UCSF Medical Center at Mission Bay - Pediatric Oncology | San Francisco | California | 94158 | — |
| Children's Hospital Colorado | Aurora | Colorado | 80045 | — |
| Nemours/ Alfred I. duPont Hospital for Children | Wilmington | Delaware | 19803 | — |
| Children's National Medical Center | Washington D.C. | District of Columbia | 20010 | — |
| Golisano Children's Hospital of Southwest Florida | Fort Myers | Florida | 33908 | — |
| University of Florida | Gainesville | Florida | 32610 | — |
| Nicklaus Children's Hospital | Miami | Florida | 33155 | — |
| Kapi'olani Medical Center | Honolulu | Hawaii | 96826 | — |
| St Jude Midwest Affiliate | Peoria | Illinois | 61637 | — |
| Riley Hospital for Children - Indiana University | Indianapolis | Indiana | 46202 | — |
| University of Louisville and Norton Children's Hospital | Louisville | Kentucky | 40202 | — |
| Johns Hopkins | Baltimore | Maryland | 21287 | — |
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02215 | — |
| CS Mott Children's Hospital | Ann Arbor | Michigan | 48109 | — |
| University of Minnesota/Masonic Cancer Center | Minneapolis | Minnesota | 55455 | — |
| University of Mississippi Medical Center | Jackson | Mississippi | 39216 | — |
| Children's Mercy Hospital and Clinics | Kansas City | Missouri | 64108 | — |
| Alliance for Childhood Diseases | Las Vegas | Nevada | 89135 | — |
| Hackensack University Medical Center | Hackensack | New Jersey | 07601 | — |
| Morristown Medical Center | Morristown | New Jersey | 07960 | — |
| Rutgers cancer Institute of NJ | New Brunswick | New Jersey | 08901 | — |
| Cohen Children's Medical Center | New Hyde Park | New York | 11040 | — |
| Columbia University/Herbert Irving Cancer Center | New York | New York | 10032 | — |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | — |
| New York Medical College | Valhalla | New York | 10595 | — |
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229 | — |
| Nationwide Children's Hospital | Columbus | Ohio | 43205 | — |
| University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | 73104 | — |
| Oregon Health & Science University | Portland | Oregon | 97239 | — |
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | — |
| Children's Hospital of Pittsburgh of UPMC | Pittsburgh | Pennsylvania | 15224 | — |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | — |
| Dell Children's Medical Center of Central Texas | Austin | Texas | 78723 | — |
| The University of Texas Southwestern Medical Center | Dallas | Texas | 75390 | — |
| Cook Children's Medical Center | Fort Worth | Texas | 76104 | — |
| Texas Children's Hospital | Houston | Texas | 77030 | — |
| The Children's Hospital of San Antonio | San Antonio | Texas | 78207 | — |
| Children's Hospital of The King's Daughters | Norfolk | Virginia | 23507 | — |
| Seattle Children's Hospital | Seattle | Washington | 98105 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 3 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03245151, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 30, 2023 · Synced Oct 23, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03245151 live on ClinicalTrials.gov.