Phase I/II Study of Silmitasertib (CX-4945) in Combination With Chemotherapy in Children and Young Adults With Relapsed Refractory Solid Tumors
Milton S. Hershey Medical Center
Summary
The purpose of this study is to evaluate the investigational drug, silmitasertib (a pill taken by mouth), in combination with FDA approved drugs for solid tumors. An investigational drug is one that has not been approved by the U.S. Food \& Drug Administration (FDA), or any other regulatory authorities around the world for use alone or in combination with any drug, for the condition or illness it is being used to treat. The goals of this part of the study are: * Establish a recommended dose of silmitasertib in combination with chemotherapy * Test the safety and tolerability of silmitasertib in combination with chemotherapy in subjects with cancer * To determine the activity of study treatments chosen based on: * How each subject responds to the study treatment * How long a subject lives without their disease returning/progressing
Eligibility
- Age range
- Up to 30 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Age: Less than 30 years old at initial diagnosis 2. Pathology All subjects must have a confirmed diagnosis of tumor type. Phase I: Relapsed/refractory solid tumors: Neuroblastoma, Ewing Sarcoma, Osteosarcoma, Rhabdomyosarcoma, Liposarcoma Phase II: * Relapsed/refractory Neuroblastoma * Relapsed/refractory Ewing sarcoma 3. Tumor assessment: Disease assessment is required for eligibility and must be done after last dose of previous therapy and prior to first dose of study drug. 4. Disease Status: Relapsed/Refractory Neuroblastoma Relapsed disease defined…
Interventions
- DrugSilmitasertib
Capsules
- DrugIrinotecan
IV
- DrugTemozolomide
Oral
- DrugVincristine
IV
Locations (21)
- University of Alabama/Children's of AlabamaBirmingham, Alabama
- Phoenix Children's HospitalPhoenix, Arizona
- UCSF Benioff Children's Hospital OaklandOakland, California
- Rady Children's HospitalSan Diego, California
- University of FloridaGainesville, Florida
- Nicklaus Children's HospitalMiami, Florida