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Protocol Details

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)

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

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)

None

Intervention(s)

Drug: Rogaratinib

Supporting Site

National Cancer Institute

Background:

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

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.


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Citations:

Not Provided

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Contacts:

Principal Investigator

Referral Contact

For more information:

Alice P. Chen, M.D.
National Cancer Institute (NCI)
NIHBC 10 - CLINICAL CENTER BG RM 8D53
10 CENTER DR
BETHESDA MD 20892
(240) 781-3320
chenali@mail.nih.gov

Ashley B. Bruns
National Cancer Institute (NCI)
National Institutes of Health
Building 10
Room 8D53
10 Center Drive
Bethesda, Maryland 20892
(240) 858-3162
ashley.bruns@nih.gov

NCI Referral Office
National Institute of Health Clinical Center (CC), 9000 Rockville Pike, Bethesda, Maryland 20892, United States: NCI Clinical Trials Referral Office
1-888-NCI-1937

Clinical Trials Number:

NCT04595747

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