Silmitasertib (CX-4945) in Combination With Chemotherapy for Relapsed Refractory Solid Tumors

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Milton S. Hershey Medical Center
Study ID
NCT06541262
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Ewing Sarcoma
  • Liposarcoma
  • Neuroblastoma
  • Osteosarcoma
  • Rhabdomyosarcoma

Eligibility Criteria

Sex
ALL
Age
N/A - 30 Years
Healthy Volunteers
Not accepted

Interventions

  • Silmitasertib — DRUG
    Capsules
  • Irinotecan — DRUG
    IV
  • Temozolomide — DRUG
    Oral
  • Vincristine — DRUG
    IV

Study Details

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

Key Dates

Start date
Oct 30, 2024
Status verified
Apr 2026
Primary completion
Nov 1, 2030
Completion
Nov 1, 2035

Study Design

Enrollment
104 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Phase I- Dose level 1
    Silmitasertib 600 mg/m2 twice a day plus Neuroblastoma: Regimen A: Irinotecan and Temozolomide Sarcoma: Regimen B: Vincristine, Irinotecan and Temozolomide
  • Experimental: Phase I- Dose level 2
    Silmitasertib 800 mg/m2 twice a day plus Neuroblastoma: Regimen A: Irinotecan and Temozolomide Sarcoma: Regimen B: Vincristine, Irinotecan and Temozolomide
  • Experimental: Phase II- Relapsed/refractory Neuroblastoma
    Silmitasertib RP2D twice a day plus Irinotecan and Temozolomide
  • Experimental: Phase II- Relapsed/refractory Ewing sarcoma
    Silmitasertib RP2D twice a day plus Vincristine, irinotecan and temozolomide

Primary Outcome Measure

Phase I- Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 2 years plus 30 days ]

Central Contacts

Locations (20)

FacilityCityStateZIPSite coordinators
University of Alabama/Children's of AlabamaBirminghamAlabama35233
Bridget Tate
[email protected]
Elizabeth Alva (PRINCIPAL_INVESTIGATOR)
Phoenix Children's HospitalPhoenixArizona85016
Brianna Lent
[email protected]
Francis Eshun (PRINCIPAL_INVESTIGATOR)
UCSF Benioff Children's Hospital OaklandOaklandCalifornia94609
Group Contact
[email protected]
Jennifer Michlitsch (PRINCIPAL_INVESTIGATOR)
Rady Children's HospitalSan DiegoCalifornia92123
William Roberts (PRINCIPAL_INVESTIGATOR)
University of FloridaGainesvilleFlorida32611
Ashley Bayne
[email protected]
Joanne Lagmay (PRINCIPAL_INVESTIGATOR)
Nicklaus Children's HospitalMiamiFlorida33155
Aixa Guadarrama
[email protected]
Maggie Fader (PRINCIPAL_INVESTIGATOR)
Arnold Palmer Hospital for ChildrenOrlandoFlorida32806
Marie Frankos
[email protected]
Jaime Libes-Bander (PRINCIPAL_INVESTIGATOR)
All Children's Hospital Johns Hopkins MedicineSt. PetersburgFlorida33701
Kevin Samnarine
[email protected]
Jennifer Dean (PRINCIPAL_INVESTIGATOR)
St. Joseph's Children's HospitalTampaFlorida33614
Jennifer Manns, RN
[email protected]
Don Eslin (PRINCIPAL_INVESTIGATOR)
Kapiolani Medical Center for Women and ChildrenHonoluluHawaii96813
Andrea Siu, MPH
[email protected]
Kelley Hutchins (PRINCIPAL_INVESTIGATOR)
Norton Children's Research Institute/Affiliated with University of Louisville School of MedicineLouisvilleKentucky40202
Jennifer Miller
[email protected]
Michael Ferguson (PRINCIPAL_INVESTIGATOR)
Children's Mercy Hospitals and ClinicsKansas CityMissouri64108
Nicole Harvey
[email protected]
Kevin Ginn (PRINCIPAL_INVESTIGATOR)
Cardinal Glennon Children's Medical CenterSt LouisMissouri63104
William Ferguson (PRINCIPAL_INVESTIGATOR)
Hackensack University Medical CenterHackensackNew Jersey07601
Kellie Daniel
[email protected]
Katharine Offer (PRINCIPAL_INVESTIGATOR)
Penn State Milton S. Hershey Medical Center and Children's HospitalHersheyPennsylvania17033
Suzanne Treadway
[email protected]
Valerie Brown (PRINCIPAL_INVESTIGATOR)
Hasbro Children's HospitalProvidenceRhode Island02903
Christopher Bouressa
[email protected]
Bradley DeNardo (PRINCIPAL_INVESTIGATOR)
Monroe Carrell Jr. Children's Hospital at VanderbiltNashvilleTennessee37232
Aida Constantinescu
[email protected]
Daniel Benedetti (PRINCIPAL_INVESTIGATOR)
Children's Medical CenterDallasTexas75235
Tanya Watt (PRINCIPAL_INVESTIGATOR)
Primary Children's HospitalSalt Lake CityUtah84113
Group Contact
[email protected]
Matthew Dietz (PRINCIPAL_INVESTIGATOR)
Virginia Commonwealth UniversityRichmondVirginia23284
Madhu Gowda (PRINCIPAL_INVESTIGATOR)

Find similar trials in Birmingham, AL

By condition
Neuroblastoma
By specialty
OncologyPediatric oncology
By research site
University of Alabama/Children's of Alabama· Birmingham, ALPhoenix Children's Hospital· Phoenix, AZUCSF Benioff Children's Hospital Oakland· Oakland, CARady Children's Hospital· San Diego, CAUniversity of Florida· Gainesville, FLNicklaus Children's Hospital· Miami, FL

Related Studies