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Studies

Interventional Active not recruiting Phase 2

NCT04595747 on ClinicalTrials.gov

Testing the Anti-cancer Drug, Rogaratinib (BAY 1163877), for Treatment of Advanced Sarcoma With Alteration in Fibroblast Growth Factor Receptor (FGFR 1-4), and in Patients With SDH-deficient Gastrointestinal Stromal Tumor (GIST)

Official 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)

  • Sponsor: National Cancer Institute (Egypt)
  • Enrollment: 48 (Estimated)
  • Study start: 2021-05-03 (Actual)
  • Primary completion: 2027-07-31 (Estimated)
  • Study completion: 2027-07-31 (Estimated)
  • Allocation: N/a
  • InterventionModel: Single Group
  • Masking: None
  • PrimaryPurpose: Treatment

Brief Summary

This phase II trial studies the effect of rogaratinib in treating patients with sarcoma with a change in a group of proteins called fibroblast growth factor receptors (FGFRs) or SDH-deficient gastrointestinal stromal tumor (GIST). Rogaratinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Conditions

  • Locally Advanced Gastrointestinal Stromal Tumor
  • Locally Advanced Sarcoma
  • Metastatic Gastrointestinal Stromal Tumor
  • Metastatic Sarcoma
  • Stage III Gastric and Omental Gastrointestinal Stromal Tumor AJCC v8
  • Stage III Small Intestinal, Esophageal, Colorectal, Mesenteric, and Peritoneal Gastrointestinal Stromal Tumor AJCC v8
  • Stage IV Gastric and Omental Gastrointestinal Stromal Tumor AJCC v8
  • Stage IV Small Intestinal, Esophageal, Colorectal, Mesenteric, and Peritoneal Gastrointestinal Stromal Tumor AJCC v8

Intervention / Treatment

  • Procedure: Biopsy Procedure
  • Procedure: Biospecimen Collection
  • Procedure: Computed Tomography
  • Procedure: Magnetic Resonance Imaging
  • Procedure: Positron Emission Tomography
  • Drug: Rogaratinib

Primary Outcome Measures

  • Objective radiographic response (Up to 30 days after removal from study)
    The duration of overall response is measured from the time measurement criteria are met for complete response or partial response (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started).

Countries

United States

Locations and Investigators

  • City of Hope Comprehensive Cancer Center, Duarte, United States
  • City of Hope at Irvine Lennar, Irvine, United States
  • UCHealth University of Colorado Hospital, Aurora, United States
  • University of Miami Miller School of Medicine-Sylvester Cancer Center, Miami, United States
  • UM Sylvester Comprehensive Cancer Center at Plantation, Plantation, United States
  • Northwestern University, Chicago, United States
  • National Cancer Institute Developmental Therapeutics Clinic, Bethesda, United States
  • National Institutes of Health Clinical Center, Bethesda, United States
  • Dana-Farber Cancer Institute, Boston, United States
  • University of Michigan Rogel Cancer Center, Ann Arbor, United States
  • Siteman Cancer Center at West County Hospital, Creve Coeur, United States
  • Washington University School of Medicine, St Louis, United States
  • Siteman Cancer Center-South County, St Louis, United States
  • Memorial Sloan Kettering Cancer Center, New York, United States
  • Ohio State University Comprehensive Cancer Center, Columbus, United States
  • UPMC Hillman Cancer Center, Pittsburgh, United States
  • Vanderbilt University/Ingram Cancer Center, Nashville, United States
  • UT MD Anderson Cancer Center, Houston, United States

Study Officials

  • Suzanne George (Principal Investigator) — Dana-Farber - Harvard Cancer Center LAO