Silmitasertib (CX-4945) in Combination With Chemotherapy for Relapsed Refractory Solid Tumors
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
AgeUp to 30
SponsorMilton S. Hershey Medical Center
About 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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Relapsed/refractory Neuroblastoma
Relapsed/refractory Ewing sarcoma
Disqualifiers
Investigational Drugs: Subjects who are currently receiving another investigational drug are excluded from participation.
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).
Trial design
Design model
Sequential
Treatments tested in this trial
Silmitasertib
DrugCapsules
Irinotecan
DrugIV
Temozolomide
DrugOral or IV
Vincristine
DrugIV
Treatment groups
104 Participants
are divided into 4 treatment groupsGroup A: Phase I- Dose level 1Experimental treatment 4 interventions
Group B: Phase I- Dose level 2Experimental treatment 4 interventions
Group C: Phase II- Relapsed/refractory NeuroblastomaExperimental treatment 3 interventions
Group D: Phase II- Relapsed/refractory Ewing sarcomaExperimental treatment 4 interventions
Trial outcomes
Primary outcomes
1
Phase I- Number of Participants with Adverse Events as a Measure of Safety and Tolerability
To characterize the safety profile of silmitasertib in combination with chemotherapy
Time frame
2 years plus 30 days2
Phase I- Number of Participants with Dose Limiting Toxicities to determine RP2D
To determine the Recommended Phase 2 Dose (RP2D) of silmitasertib in combination with chemotherapy
Time frame
21 days3
Phase II- Determine the Overall Response Rate (ORR) of Participants using INRC
To evaluate the efficacy of silmitasertib in combination with chemotherapy in 2 disease cohorts, based upon Overall response rate (ORR)
Time frame
2 yearsSecondary outcomes
1
Phase I- Determine the Overall Response Rate (ORR) of Participants using INRC
To evaluate the efficacy of silmitasertib in combination with chemotherapy in 2 disease cohorts based upon Overall response rate (ORR)
Time frame
2 years2
Number of participants with progression free survival (PFS) during study
To evaluate the efficacy of silmitasertib in combination with chemotherapy in 2 disease cohorts based upon Progression Free Survival (PFS)
Time frame
2 years3
Phase II- Length of time that participants experience Overall Survival (OS)
To evaluate the efficacy of silmitasertib in combination with chemotherapy in 2 disease cohorts based upon Overall Survival (OS)
Time frame
7 years4
Phase II- Number of Participants with Adverse Events as a Measure of Safety and Tolerability
To characterize the safety profile of silmitasertib in combination with chemotherapy
Time frame
2 years plus 30 daysSponsors and contacts
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Source ClinicalTrials.gov