Clinical Trials in South Korea / NCT03899792
Active, not recruiting
Phase 1/2
A Study of Oral LOXO-292 (Selpercatinib) in Pediatric Participants With Advanced Solid or Primary Central Nervous System (CNS) Tumors
NCT03899792 · tracked via the Priya Life Science South Korea tracker
Condition(s) studied
Medullary Thyroid CancerInfantile MyofibromatosisInfantile FibrosarcomaPapillary Thyroid CancerSoft Tissue Sarcoma
Study summary
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.
Eligibility
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\[s\])
Primary outcome measure(s)
- Phase 1: Number of Participants With Dose Limiting Toxicities (DLTs) — Cycle 1 (28 Day Cycle)
A DLT was any of the adverse events that starts on or after the first administration of study drug listed below, as defined by the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0. * Any Grade(G) ≥3 nonhematologic toxicity except G3 fatigue, nausea, tendon reflex decrease, weight gain attributable to normal growth and development. * G3 vomiting/diarrhea was DLT only if it persists \>48 h despite standard of care treatment. * G4 vomiting/diarrhea was DLT regardless of duration. * Any toxicity, regardless of the NCI CTCAE v5.0 grade, resulting in discontinuation or dose reduction of treatment (except symptoms related to progressive disease (PD)). * G4/G3 thrombocytopenia with G1 or higher bleeding. * G4 anemia lasting \>8 days, despite supportive therapy. * G4 neutropenia, lasting \>8 days, despite supportive therapy - Phase 2: Percentage of Participants With Overall Response Rate (ORR) in Study — Date of first dose to disease progression or death (Up to 62.4 Months)
ORR: Percentage of participants who achieve best overall response Complete Response (CR) or Partial Response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST). * CR is defined as disappearance of all target lesions. * PR is defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.
Trial sites (26)
| Facility | City | Region | Status |
|---|---|---|---|
| Childrens Hospital of Los Angeles | Los Angeles | California | |
| The Children's Hospital for Cancer and Blood Disorders | Aurora | Colorado | |
| Nemours Children's Health | Orlando | Florida | |
| Dana-Farber Cancer Institute | Boston | Massachusetts | |
| University of Minnesota Hospital | Minneapolis | Minnesota | |
| Memorial Sloan Kettering Cancer Center | New York | New York | |
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | |
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | |
| St. Jude Children's Research Hospital | Memphis | Tennessee | |
| University of Texas Southwestern Medical Center at Dallas | Dallas | Texas | |
| Texas Childrens Hospital | Houston | Texas | |
| Seattle Children's Hospital Research Foundation | Seattle | Washington | |
| The Children's Hospital at Westmead | Westmead | New South Wales | |
| Royal Children's Hospital | Melbourne | Victoria | |
| The Hospital for Sick Children | Toronto | Ontario | |
| Rigshospitalet | Copenhagen | Denmark | |
| Gustave Roussy | Villejuif | France | |
| Universitätsklinikum Heidelberg | Heidelberg | Baden-Wurttemberg | |
| Fondazione IRCCS Istituto Nazionale dei Tumori | Milan | Lombardy | |
| Hokkaido University Hospital | Sapporo | Hokkaido | |
| National Cancer Center Hospital | Chuo-ku | Tokyo | |
| Hiroshima University Hospital | Hiroshima | Japan | |
| Kyoto University Hospital | Kyoto | Japan | |
| Seoul National University Hospital | Seoul | Korea | |
| Hospital Universitari Vall d'Hebron | Barcelona | Barcelona [Barcelona] | |
| University College Hospital - London | London | Greater London |
More Eli Lilly and Company trials in South Korea
Other trials for the same condition
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT03899792 on ClinicalTrials.gov ↗ ← All trials in South Korea