Silmitasertib + Chemotherapy for Recurrent Solid Tumors
What You Need to Know Before You Apply
What is the purpose of 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
Will I have to stop taking my current medications?
The trial requires that you stop taking certain medications, including other investigational drugs, anticancer agents, Vitamin K antagonists (like warfarin), and statins (a type of cholesterol-lowering medication). If you are on any of these, you will need to stop them before participating.
What makes the drug Silmitasertib unique for treating recurrent solid tumors?
Silmitasertib is unique because it targets a specific enzyme called CK2, which is involved in cancer cell growth and survival, making it different from other treatments that may not target this enzyme. This approach could potentially offer a new way to treat recurrent solid tumors that have not responded to standard therapies.12345
Who Is on the Research Team?
Chandrika Behura, MD
Principal Investigator
Penn State Health Children's Hospital
Are You a Good Fit for This Trial?
This trial is for young patients under 30 years old initially diagnosed with specific solid tumors like Neuroblastoma, Ewing Sarcoma, Osteosarcoma, Rhabdomyosarcoma, or Liposarcoma that have not responded to treatment or have come back after treatment. Patients must have a confirmed diagnosis and meet certain criteria based on their type of cancer.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive silmitasertib in combination with chemotherapy to establish a recommended dose and test safety and tolerability
Follow-up
Participants are monitored for safety, tolerability, and progression-free survival after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Silmitasertib
Silmitasertib is already approved in United States for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
Milton S. Hershey Medical Center
Lead Sponsor