TRIAL DETAIL

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)

Drug:
Trial Name:
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)
NCT#:
Conditions:
Sarcoma
Status:
Recruiting
Phase:
2
Start Date 07/27/2021
Age of Trial (yrs) .2
Treatment Phase:
Gleevec-resistant
Drug Category:
FGFR inhibitor
Strategy:
Block FGFR Pathway
Trial Type:
Specifically GIST plus other cancers
Other Protocol IDs:
NCI-2020-08011
Sponsor:
National Cancer Institute (NCI)
Patient Contact:
Contact email:
Contact Phone:
Randomized:
IV or Oral:
Oral
Trial Notes:
Inclusion Criteria:

Participant must have histologically confirmed sarcoma with FGFR alteration identified by next-generation sequencing profiling with the exception of SDH-deficient GIST who can be enrolled regardless of FGFR status. Initial testing can be performed on archival tissue
Presence of measurable disease: Patient must have measurable disease
Patients must have progressed following at least one standard prior chemotherapy regimen with the exception of SDH-deficient GIST for which there is no standard of care

Trial Links

Trial Results

Drug Information

Rogaratinib: A potent and selective pan-FGFR inhibitor with broad antitumor activity in FGFR-overexpressing preclinical cancer models
 

Trial Sites

Name
Address
City
State
Zip
Country
450 Brookline Ave
Boston
MA
02215-5450
USA
Building 10, Room 4-3760
Bethesda
MD
20892
USA
1500 E. Duarte Road
Duarte
CA
91010
USA
1275 York Ave
New York
NY
10065
USA