This study is currently recruiting participants.
Number
000475-C
Sponsoring Institute
National Cancer Institute (NCI)
Recruitment Detail
Type: Participants currently recruited/enrolled Gender: Male & Female Min Age: 18 Years Max Age: N/A
Referral Letter Required
No
Population Exclusion(s)
Fetuses;Pregnant Women;Children
Keywords
Solid Tumors; Personalized Medicine
Recruitment Keyword(s)
None
Condition(s)
Sarcoma; SDH-deficient Gastrointestinal Stromal Tumor
Investigational Drug(s)
Rogaratinib
Investigational Device(s)
Intervention(s)
Drug: Rogaratinib
Supporting Site
National Cancer Institute
Sarcomas are a complex group of malignancies. They develop in connective tissue in bone or soft tissue. In the United States, there are about 12,000-15,000 new cases of sarcoma each year, and 4,000-5,000 deaths. Researchers want to see if a new drug can help treat sarcomas.
Objective:
To test if rogaratinib will shrink tumors in patients with a sarcoma that has alteration in FGFR or patients with (SDH)-deficient GIST.
Eligibility:
Adults age 18 and older who have sarcoma, and their cancer has a change in a group of proteins called FGFRs, or they have a type of sarcoma called succinate dehydrogenase (SDH)-deficient GIST.
Design:
Participants will be screened with a medical record review. For those who do not have SDH-deficient GIST, existing test results will be reviewed to find out if their tumor has a specific change in FGFRs. People with SDH-deficient GIST do not need this screening test.
Participants will have an eye exam before they start to take the study drug.
Participants will take the study drug tablets by mouth, twice a day, every day of each cycle. One cycle lasts 28 days. They will take the drug for up to 24 cycles.
Participants will have study visits every cycle. At these visits, they will have a physical exam. They will give blood samples. Their tumor may be measured using imaging scans.
Participants will have at least one tumor biopsy.
After treatment ends, participants will be followed for side effects for 30 days. They will have a phone call 30 days after their last dose of the study drug.
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Eligibility: - 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. - Progression of disease following at least one standard prior chemotherapy with the exception of SDH-deficient GIST for which there is no standard of care. - One site of disease amendable to biopsy and willingness to undergo biopsy - Age >=18 with ECOG <= 2 and adequate organ and marrow function.
- 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.
- Progression of disease following at least one standard prior chemotherapy with the exception of SDH-deficient GIST for which there is no standard of care.
- One site of disease amendable to biopsy and willingness to undergo biopsy
- Age >=18 with ECOG <= 2 and adequate organ and marrow function.
Principal Investigator
Referral Contact
For more information: