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

StatusRecruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Study sites: 23 to 24
    • Eligibility criteria expanded, about 48 words
  2. Study sites: 22 to 23v11
  3. Study sites: 21 to 22
    • Eligibility criteria expanded, about 70 words
    v10
  4. Study sites: 20 to 21v9
  5. Study sites: 18 to 20v8
Show 6 earlier versionsHide 6 earlier versions
  1. Study sites: 5 to 18v7
  2. Primary endpoints revised (3)v6 Show 4 more changesShow less
    • Enrollment target: 114 to 104
    • Study sites: 1 to 5
    • Secondary endpoints: 4 to 5
    • Eligibility criteria expanded, about 4 words
  3. Start date changed from estimate of Nov 30, 2024 to Oct 30, 2024
    • Site contact updated
    v5
  4. Trial status: Not Yet Recruiting to Recruitingv4 Show 4 more changesShow less
    • Start date: Oct 1, 2024 to Nov 30, 2024
    • Study sites: 0 to 1
    • Primary completion date: Sep 1, 2030 to Nov 1, 2030
    • Study completion date: Sep 1, 2035 to Nov 1, 2035
  5. Start date: Sep 1, 2024 to Oct 1, 2024v3
  6. Re-verified, no change to tracked fieldsv2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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
Trial Details
NCT Number NCT06541262
Lead Sponsor Milton S. Hershey Medical Center
Conditions
(from sponsor)		 Neuroblastoma, Ewing Sarcoma, Osteosarcoma, Rhabdomyosarcoma, Liposarcoma
Related terms Liposarcoma, Neuroblastoma, Osteosarcoma, Rhabdomyosarcoma, Sarcoma, Ewing
Enrollment 104 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov