Clinical Trials / Research Studies
LOXO-RET-18036: A Study of Oral LOXO-292 in Pediatric Patients With Advanced Solid or Primary Central Nervous System Tumors
Why are we doing this research?
To determine the safety of oral LOXO-292 in pediatric patients with advanced solid tumors: Dose limiting toxicities (DLTs) [ Time Frame: During the first 28-day cycle of LOXO-292 treatment ]
LOXO-RET-18036: A Phase 1/2 Study of the Oral RET Inhibitor LOXO 292 in Pediatric Patients With Advanced RET-Altered Solid or Primary Central Nervous System Tumors
Who can participate?
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 (patients 16 years and older) or Lansky (patients younger than 16) performance score of at least 50.
- Patient 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 2 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 patient 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 patients who will receive LOXO-292 suspension.
- Current treatment with proton pump inhibitors.
Ages
- 6 Months to 21 Years
Conditions
- Brain and Spinal Tumor Medulloblastoma Relapse - Refractory
- Adult - Brain and Spinal Tumor Medulloblastoma Relapse - Refractory
- Brain and Spinal Tumor Low Grade Glioma Relapse - Refractory
- Adult - Brain and Spinal Tumor Low Grade Glioma Relapse - Refractory
- Brain and Spinal Tumor DIPG High Grade Glioma Relapse - Refractory
- Adult - Brain and Spinal Tumor DIPG High Grade Glioma Relapse - Refractory
- Brain and Spinal Tumor Ependymoma Relapse
- Adult - Brain and Spinal Tumor Ependymoma Relapse
- Brain and Spinal Tumor Neurofibromatosis Sarcoma MPNST Relapse - Refractory
- Adult - Brain and Spinal Tumor Neurofibromatosis Sarcoma MPNST Relapse - Refractory
- Sarcoma Osteosarcoma Relapse - Refractory
- Adult - Sarcoma Osteosarcoma Relapse - Refractory
- Sarcoma Ewing Relapse Relapse - Refractory
- Adult - Sarcoma Ewing Relapse Relapse - Refractory
- Sarcoma Rhabdomyosarcoma Relapse - Refractory
- Adult - Sarcoma Rhabdomyosarcoma Relapse - Refractory
- Neuroblastoma Relapse - Refractory
- Adult - Neuroblastoma Relapse - Refractory
- Adult - Liver Relapse - Refractory
- Liver Relapse - Refractory
- Kidney Relapse - Refractory
- Adult - Kidney Relapse - Refractory
Contact
Cincinnati Children’s Hospital Medical CenterDivision of Hematology/Oncology
3333 Burnet Ave., Cincinnati, OH 45229-3039
Phone: 513-636-2799
cancer@cchmc.org
3333 Burnet Avenue, Cincinnati, Ohio 45229-3026
© 1999-2024 Cincinnati Children's Hospital Medical Center. All rights reserved.
