A Study of Oral LOXO-292 (Selpercatinib) in Pediatric Participants With Advanced Solid or Primary Central Nervous System (CNS) Tumors

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A Study of Oral LOXO-292 (Selpercatinib) in Pediatric Participants With Advanced Solid or Primary Central Nervous System (CNS) Tumors

Study Purpose

This is an open-label, multi-center Phase 1/2 study of oral LOXO-292 in pediatric participants with an activating rearranged during transfection (RET) alteration and an advanced solid or primary CNS tumor.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	6 Months - 21 Years
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- Advanced or metastatic solid or primary CNS tumor which has failed standard of care therapies.

- 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:

- Major surgery within two weeks prior to planned start of LOXO-292.

- 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])

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT03899792
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 1/Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Eli Lilly and Company
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	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)
Principal Investigator Affiliation	Eli Lilly and Company
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Active, not recruiting
Countries	Australia, Canada, Denmark, France, Germany, Italy, Japan, South Korea, Spain, United Kingdom, United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Medullary Thyroid Cancer, Infantile Myofibromatosis, Infantile Fibrosarcoma, Papillary Thyroid Cancer, Soft Tissue Sarcoma

Additional Details

This study includes 2 parts: phase 1 (dose escalation) and phase 2 (dose expansion). In phase 1, participants will be enrolled using a rolling 6 dose escalation scheme. The starting dose of LOXO-292 is equivalent to the adult recommended phase 2 dose of 160 milligrams (mg) twice a day (BID). Once the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) is identified, participants will be enrolled to one of four phase 2 dose expansion cohorts depending on tumor histology and tumor genotype. Cycle length will be 28 days.

Arms & Interventions

Arms

Experimental: LOXO-292

Phase 1- Dose Escalation and determination of MTD; multiple dose levels of LOXO-292 to be evaluated; Phase 2 - The MTD/recommended dose from Phase 1

Interventions

Drug: - LOXO-292

Oral LOXO-292

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Childrens Hospital of Los Angeles, Los Angeles 5368361, California 5332921

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Childrens Hospital of Los Angeles

Los Angeles 5368361, California 5332921, 90027

Aurora 5412347, Colorado 5417618

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The Children's Hospital for Cancer and Blood Disorders

Aurora 5412347, Colorado 5417618, 80045

Nemours Children's Health, Orlando 4167147, Florida 4155751

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Nemours Children's Health

Orlando 4167147, Florida 4155751, 32827

Dana-Farber Cancer Institute, Boston 4930956, Massachusetts 6254926

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Dana-Farber Cancer Institute

Boston 4930956, Massachusetts 6254926, 02215

University of Minnesota Hospital, Minneapolis 5037649, Minnesota 5037779

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University of Minnesota Hospital

Minneapolis 5037649, Minnesota 5037779, 55455

Memorial Sloan Kettering Cancer Center, New York 5128581, New York 5128638

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Memorial Sloan Kettering Cancer Center

New York 5128581, New York 5128638, 10065

Cincinnati 4508722, Ohio 5165418

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Cincinnati Children's Hospital Medical Center

Cincinnati 4508722, Ohio 5165418, 45229-3039

Children's Hospital of Philadelphia, Philadelphia 4560349, Pennsylvania 6254927

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Children's Hospital of Philadelphia

Philadelphia 4560349, Pennsylvania 6254927, 19104

St. Jude Children's Research Hospital, Memphis 4641239, Tennessee 4662168

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St. Jude Children's Research Hospital

Memphis 4641239, Tennessee 4662168, 38105

Dallas 4684888, Texas 4736286

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University of Texas Southwestern Medical Center at Dallas

Dallas 4684888, Texas 4736286, 75390-9063

Texas Childrens Hospital, Houston 4699066, Texas 4736286

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Texas Childrens Hospital

Houston 4699066, Texas 4736286, 77025

Seattle 5809844, Washington 5815135

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Seattle Children's Hospital Research Foundation

Seattle 5809844, Washington 5815135, 98105

International Sites

The Children's Hospital at Westmead, Westmead 2143973, New South Wales 2155400, Australia

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The Children's Hospital at Westmead

Westmead 2143973, New South Wales 2155400, 2145

Royal Children's Hospital, Melbourne 2158177, Victoria 2145234, Australia

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Royal Children's Hospital

Melbourne 2158177, Victoria 2145234, 3052

The Hospital for Sick Children, Toronto 6167865, Ontario 6093943, Canada

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The Hospital for Sick Children

Toronto 6167865, Ontario 6093943, M5G 1X8

Rigshospitalet, Copenhagen 2618425, Denmark

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Rigshospitalet

Copenhagen 2618425, , 2200

Gustave Roussy, Villejuif 2968705, France

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Gustave Roussy

Villejuif 2968705, , 94805

Universitätsklinikum Heidelberg, Heidelberg 2907911, Baden-Wurttemberg 2953481, Germany

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Universitätsklinikum Heidelberg

Heidelberg 2907911, Baden-Wurttemberg 2953481, 69115

Milan 3173435, Lombardy 3174618, Italy

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Fondazione IRCCS Istituto Nazionale dei Tumori

Milan 3173435, Lombardy 3174618, 20133

Hokkaido University Hospital, Sapporo 2128295, Hokkaido 2130037, Japan

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Hokkaido University Hospital

Sapporo 2128295, Hokkaido 2130037, 060-8648

National Cancer Center Hospital, Chuo-ku, Tokyo 1850144, Japan

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National Cancer Center Hospital

Chuo-ku, Tokyo 1850144, 104-0045

Hiroshima University Hospital, Hiroshima 1862415, Japan

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Hiroshima University Hospital

Hiroshima 1862415, , 734-8551

Kyoto University Hospital, Kyoto 1857910, Japan

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Kyoto University Hospital

Kyoto 1857910, , 606-8507

Seoul National University Hospital, Seoul 1835848, Korea, South Korea

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Seoul National University Hospital

Seoul 1835848, Korea, 03080

Hospital Universitari Vall d'Hebron, Barcelona 3128760, Barcelona [Barcelona], Spain

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Hospital Universitari Vall d'Hebron

Barcelona 3128760, Barcelona [Barcelona], 8035

University College Hospital - London, London 2643743, Greater London, United Kingdom

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University College Hospital - London

London 2643743, Greater London, NW1 2BU

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