Study on Silmitasertib with Chemotherapy for Treating Relapsed or Hard-to-Treat Solid Tumors

Sponsor: Milton S. Hershey Medical Center

Sponsor score: 0

ClinicalTrials ID:NCT06541262

Provider View

This clinical trial is testing a new drug, silmitasertib, taken as a pill, combined with approved chemotherapy drugs to treat solid tumors that have returned or are difficult to treat. The study aims to find the best dose, check safety, and see how well the treatment works.

Patient Parameters

Program Overview

The purpose of this study is to test a new drug called silmitasertib, which is taken as a pill, in combination with approved chemotherapy drugs for treating solid tumors that have come back or are hard to treat. The study will help determine the best dose of silmitasertib when used with chemotherapy, check how safe and tolerable the combination is, and see how well it works based on how patients respond and how long they live without the cancer returning or getting worse.

Eligibility Criteria

Inclusion Criteria

  • Must be under 30 years old at the time of initial cancer diagnosis.
  • Must have a confirmed diagnosis of certain types of solid tumors, such as Neuroblastoma, Ewing Sarcoma, Osteosarcoma, Rhabdomyosarcoma, or Liposarcoma.
  • Must have cancer that has returned after treatment or has not responded to standard treatments.
  • Must have measurable or detectable cancer through scans or tests.
  • Must have recovered from previous cancer treatments and meet specific timelines for starting this study.
  • Must be able to swallow pills.
  • Must have good organ function, including heart, blood, liver, and kidneys.
  • Women who can become pregnant must have a negative pregnancy test and agree to use birth control.
  • Must provide written consent to participate in the study.

Exclusion Criteria

  • Currently taking another investigational drug or cancer treatment.
  • Taking certain medications like blood thinners (warfarin) or cholesterol-lowering drugs (statins).
  • Have an uncontrolled infection.
  • Have a serious illness that could affect participation in the study.
  • Have digestive issues that affect swallowing or absorbing medication.
  • Are breastfeeding or have a history of other cancers.

Locations

FACILITYZIPCITYSTATE
Penn State Milton S. Hershey Medical Center and Children's Hospital17033HersheyPennsylvania

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