A Phase II Study of Rogaratinib for Recurrent Sarcoma with FGFR Alterations and SDH-Deficient Gastrointestinal Stromal Tumors

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Full Title

Phase 2 Study of Rogaratinib (BAY 1163877) in the Treatment of Patients with Sarcoma Harboring Alterations in Fibroblast Growth Factor Receptor (FGFR) 1-4 and SDH-deficient Gastrointestinal Stromal Tumor (GIST) (NCI 10411) (CIRB)

Purpose

The purpose of this study is to assess the safety and effectiveness of the drug rogaratinib in patients with recurrent sarcoma with a change in a group of proteins called fibroblast growth factor receptors (FGFRs) or patients with SDH-deficient gastrointestinal stromal tumor (GIST). Rogaratinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is taken orally (by mouth).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Participant must have advanced sarcoma with an FGFR alteration that has continued to grow despite therapy. Those with SDH-deficient GIST can be enrolled regardless of their FGFR status or prior therapy.
  • At least 2 weeks must pass between the completion of prior treatment and receipt of rogaratinib.
  • Patients must be able to walk and do routine activities for more than half of their normal waking hours.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Katherine Thornton at 646-888-6952.

Protocol

21-131

Phase

II

Investigator

Thornton, Katherine, MD

Co-Investigators