A Study of Oral LOXO-292 (Selpercatinib) in Pediatric Participants With Advanced Solid or Primary Central Nervous System (CNS) Tumors
NCT ID: NCT03899792
Last Updated: 2026-01-06
Study Results
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View full resultsBasic Information
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ACTIVE_NOT_RECRUITING
PHASE1/PHASE2
36 participants
INTERVENTIONAL
2019-06-13
2029-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Cohort 1: Medullary Thyroid Cancer (MTC) Group
Participants in this cohort had MTC and received 160 mg of selpercatinib BID orally on Days 1 through 28 of a 28-day cycle.
The treatment was continued until participants experienced a progressive disease, unacceptable toxicity, or other protocol-defined reason for discontinuation.
Selpercatinib
Oral LOXO-292
Cohort 2: Papillary Thyroid Cancer (PTC) Group
Participants in this cohort had PTC and received 160 mg of selpercatinib BID orally on Days 1 through 28 of a 28-day cycle.
The treatment was continued until participants experienced a progressive disease, unacceptable toxicity, or other protocol-defined reason for discontinuation.
Selpercatinib
Oral LOXO-292
Cohort 3: Other Cancer Group
Participants in this cohort had other (REarranged during Transfection (RET)-altered non-thyroid) cancer and received 160 mg of selpercatinib BID orally on Days 1 through 28 of a 28-day cycle.
The treatment was continued until participants experienced a progressive disease, unacceptable toxicity, or other protocol-defined reason for discontinuation.
Selpercatinib
Oral LOXO-292
Interventions
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Selpercatinib
Oral LOXO-292
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Evidence of an activating RET gene alteration in the tumor and/or blood
* Measurable or non-measurable disease
* Karnofsky (participants 16 years and older) or Lansky (participants younger than 16) performance score of at least 50
* Participant with primary CNS tumors or cerebral metastases must be neurologically stable for 7 days prior and must not have required increasing doses of steroids within the last 7 days
* Adequate hematologic, hepatic and renal function.
* Ability to receive study drug therapy orally or via gastric access
* Willingness of men and women of reproductive potential to observe conventional and effective birth control
Exclusion Criteria
* Clinically significant, uncontrolled cardiac, cardiovascular disease or history of myocardial infarction within 6 months prior to planned start of LOXO-292
* Active uncontrolled systemic bacterial, viral, fungal or parasitic infection
* Clinically significant active malabsorption syndrome
* Pregnancy or lactation
* Uncontrolled symptomatic hyperthyroidism or hypothyroidism (i.e. the participant required a modification to current thyroid medication in the 7 days before start of LOXO-292)
* Uncontrolled symptomatic hypercalcemia or hypocalcemia
* Known hypersensitivity to any of the components of the investigational agent, LOXO-292 or Ora-Sweet® SF and OraPlus®, for participants who will receive LOXO-292 suspension
* Prior treatment with a selective RET inhibitor(s) (including investigational selective RET inhibitor\[s\])
6 Months
21 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Loxo Oncology, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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Childrens Hospital of Los Angeles
Los Angeles, California, United States
The Children's Hospital for Cancer and Blood Disorders
Aurora, Colorado, United States
Nemours Children's Health
Orlando, Florida, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
University of Minnesota Hospital
Minneapolis, Minnesota, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
St. Jude Children's Research Hospital
Memphis, Tennessee, United States
University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, United States
Texas Childrens Hospital
Houston, Texas, United States
Seattle Children's Hospital Research Foundation
Seattle, Washington, United States
The Children's Hospital at Westmead
Westmead, New South Wales, Australia
Royal Children's Hospital
Melbourne, Victoria, Australia
The Hospital for Sick Children
Toronto, Ontario, Canada
Rigshospitalet
Copenhagen, , Denmark
Gustave Roussy
Villejuif, , France
Universitätsklinikum Heidelberg
Heidelberg, Baden-Wurttemberg, Germany
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, Lombardy, Italy
Hokkaido University Hospital
Sapporo, Hokkaido, Japan
National Cancer Center Hospital
Chuo-ku, Tokyo, Japan
Hiroshima University Hospital
Hiroshima, , Japan
Kyoto University Hospital
Kyoto, , Japan
Seoul National University Hospital
Seoul, Korea, South Korea
Hospital Universitari Vall d'Hebron
Barcelona, Barcelona [Barcelona], Spain
University College Hospital - London
London, Greater London, United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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J2G-OX-JZJJ
Identifier Type: OTHER
Identifier Source: secondary_id
LOXO-RET-18036
Identifier Type: OTHER
Identifier Source: secondary_id
2019-000212-28
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
17493
Identifier Type: -
Identifier Source: org_study_id
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