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Information is also accessible through the patient and families tab. Family friendly summaries are created and reviewed by our advocacy partners. The information is updated to the best of our knowledge but might not reflect the latest information. Note that most studies are only available at a limited number of sites, please click on ‘further information’ for details. Studies, particularly early phase trials, may also temporarily close to enrolment or not have slots available for all treatment groups. In all cases, study teams at individual C17 centres will have the most up-to-date information.

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Title
Status

 

BCC021 - Phase I/II Study of Silmitasertib (CX-4945) in Combination With Chemotherapy in Children and Young Adults With Relapsed Refractory Solid Tumors

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BCC021 - Phase I/II Study of Silmitasertib (CX-4945) in Combination With Chemotherapy in Children and Young Adults With Relapsed Refractory Solid Tumors

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DiagnosisRecurrent Neuroblastoma, Ewing's Sarcoma, Osteosarcoma, Rhabdomyosarcoma, LiposarcomaStudy StatusOpen
PhaseI/II
Ageup to 30 YearsRandomisationNO
Line of treatmentDisease relapse or progression
Routes of Treatment AdministrationDrug: Silmitasertib (Oral) Other Names: CX-4945 Drug: Irinotecan (IV) Drug: Temozolomide (Oral) ± Drug: Vincristine (IV)
Last Posted Update2026-02-18
ClinicalTrials.gov #NCT06541262
International Sponsor
Milton S. Hershey Medical Center
Principal Investigators for Canadian Sites
CHU Ste-Justine - Dr. Monia Marzouki
Centres

Aucun centre rattaché

 

 

Study Description

 

The purpose of this study is to learn more about how safe and effective a drug called silmitasertib (an oral pill) is in combination with other FDA approved chemotherapy drugs to treat certain kinds of solid tumours. 

Inclusion Criteria
  • Participants must be 30 years or younger
  • A confirmed tumor type of Neuroblastoma, Ewing sarcoma, Osteosarcoma, Rhabdomyosarcoma, or Liposarcoma that has come back or not responded to standard treatment
  • Doctors must be able to see signs of cancer on a scan or in the bone marrow
  • Must have recovered from past treatments, with enough time passed since chemo, radiation, immunotherapy, or transplant
  • Must meet all organ function and bloodwork requirements
  • Must be up and about for 50% of waking hours
  • If patient can become pregnant, a negative pregnancy test and adequate birth control is required
  • Signed informed consent