Silmitasertib (CX-4945) in Combination With Chemotherapy for Relapsed Refractory Solid Tumors (NCT06541262) | Clinical Trial Compass
RecruitingPhase 1/2
Silmitasertib (CX-4945) in Combination With Chemotherapy for Relapsed Refractory Solid Tumors
United States104 participantsStarted 2024-10-30
Plain-language summary
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
Who can participate
Age range30 Years
SexALL
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Inclusion criteria
✓. 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
✓. Tumor assessment:
✓. Disease Status:
✓. Any age with International Neuroblastoma Risk Group (INRG) Stage L2, MS, or M with MYCN amplification
✓. Age ≥ 547 days and INRG Stage M regardless of biologic features
✓. Any age initially diagnosed with INRG Stage L1 MYCN amplified NBL who have progressed to Stage M without systemic chemotherapy
✓. Age ≥ 547 days of age initially diagnosed with INRG Stage L1, L2, or MS who have progressed to Stage M without systemic chemotherapy
Exclusion criteria
✕. Investigational Drugs: Subjects who are currently receiving another investigational drug are excluded from participation.
What they're measuring
1
Phase I- Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Timeframe: 2 years plus 30 days
2
Phase I- Number of Participants with Dose Limiting Toxicities to determine RP2D
Timeframe: 21 days
3
Phase II- Determine the Overall Response Rate (ORR) of Participants using INRC
✕. 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).
✕. Infection: Subjects who have an uncontrolled infection are not eligible until the infection is judged to be well controlled in the opinion of the investigator.
✕. Subjects who, in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study, or in whom compliance is likely to be suboptimal, should be excluded.
✕. Subjects with any clinically significant unrelated systemic illness (serious infections or significant cardiac, pulmonary, hepatic or other organ dysfunction), that in the opinion of the investigator would compromise the subject's ability to tolerate protocol therapy, put them at additional risk for toxicity or would interfere with the study procedures or results.
✕. Subjects with any of the following gastrointestinal disorders: