Silmitasertib (CX-4945) in Combination With Chemotherapy for Relapsed Refractory Solid Tumors
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
AgeUp to 30
SponsorMilton S. Hershey Medical Center
About this trial
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 criteria
Qualifiers
Age: Less than 30 years old at initial diagnosis
Pathology All subjects must have a confirmed diagnosis of tumor type. Phase I: Relapsed/refractory solid tumors: Neuroblastoma, Ewing Sarcoma, Osteosarcoma, Rhabdomyosarcoma, Liposarcoma
Relapsed/refractory Neuroblastoma
Relapsed/refractory Ewing sarcoma
Disqualifiers
Investigational Drugs: Subjects who are currently receiving another investigational drug are excluded from participation.
Anti-cancer Agents: Subjects who are currently receiving other anticancer agents are not eligible. Subjects must have fully recovered from the hematological and bone marrow suppression effects of prior therapy.
Subjects who are currently receiving Vitamin K antagonists (warfarin).
Subjects who are currently receiving the class of lipid-lowering medications HMG-CoA reductase inhibitors (statins).
Trial design
Treatments tested in this trial
- Silmitasertib
- Irinotecan
- Temozolomide
- Vincristine
Treatment groups
104 Participants
are divided into 4 treatment groupsLocations
22Canada
UHC Sainte-JustineQC H3S 2G4, MontrealQuebec, Canada
United States
Alabama
University of Alabama/Children's of Alabama35233, Birmingham United States
Arizona
Phoenix Children's Hospital85016, Phoenix United States
California
UCSF Benioff Children's Hospital Oakland94609, Oakland United States
Sponsors and collaborators
Milton S. Hershey Medical Center
Lead sponsor
Source ClinicalTrials.gov