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:
Completed
Phase:
2
Start Date 07/27/2021
Age of Trial (yrs) 2.7
Treatment Phase:
Gleevec-resistant
Drug Category:
SDH-directed
Strategy:
Block FGFR Pathway
Trial Type:
Specifically GIST plus other cancers
Other Protocol IDs:
NCI-2020-08011 21-070 10411 [Dana-Farber - Harvard Cancer Center LAO] 10411 [CTEP] UM1CA186709 [U.S. NIH Grant/Contract]
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.
Participant must be willing to undergo pre-treatment biopsy if disease site is amenable to biopsy and low risk for the biopsy procedure. If biopsy is not possible, eligibility may be approved after discussion with the Study Chair. Of note, a minimum of 15 participants in each arm open to stage 2 should have disease amenable to biopsy. For those arms open in stage 1, all patients should have biopsiable disease

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
660 S. Euclid Ave
St. Louis
MO
63110
USA
Pittsburgh
PA
15232
USA
1665 N. Ursula St.
Aurora
CO
80045
USA
1475 Northwest 12th Ave
Miami
FL
33136
USA
1500 East Medical Center Dr
Ann Arbor
MI
48109
USA
Columbus
OH
43210
USA
2220 Pierce Ave.
Nashville
TN
37232
USA
Irvine
CA
92618
USA
675 North St. Clair
Chicago
IL
60611
USA
1505 Holcombe Blvd.
Houston
TX
77030
USA