Study on the Anti-Cancer Drug Rogaratinib for Treating Advanced Sarcoma and SDH-Deficient Gastrointestinal Stromal Tumor (GIST)
Sponsor: National Cancer Institute (NCI)
ClinicalTrials ID:NCT04595747
This clinical trial is testing the drug rogaratinib to see if it can help treat patients with advanced sarcoma or SDH-deficient gastrointestinal stromal tumor (GIST) by blocking certain proteins that help cancer cells grow.
Patient Parameters
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Program Overview
This phase II study is investigating how well the drug rogaratinib works in patients with advanced sarcoma that has changes in fibroblast growth factor receptors (FGFRs) or in patients with SDH-deficient gastrointestinal stromal tumor (GIST). Rogaratinib may help stop tumor growth by blocking enzymes needed for cancer cells to grow.
Description
The main goal of this study is to see how well rogaratinib works in shrinking tumors in two groups of patients: those with sarcoma that has changes in FGFR proteins and those with advanced SDH-deficient GIST. Researchers will also look at how long patients live without the cancer getting worse and check the safety of the drug.
Patients will take rogaratinib pills twice a day in 28-day cycles, for up to 24 cycles, unless the cancer progresses or side effects become too severe. During the study, patients will have regular scans and may need to provide blood samples and tumor biopsies to help researchers understand how the drug works.
After finishing the treatment, patients will have a follow-up visit 30 days later to check their health.
Eligibility Criteria
Inclusion Criteria
- Must have a confirmed diagnosis of sarcoma with FGFR changes or SDH-deficient GIST.
- Cancer must be advanced or spread and cannot be removed by surgery.
- Must have measurable cancer that can be tracked.
- Must have tried at least one standard chemotherapy treatment, except for SDH-deficient GIST.
- Must be willing to have a biopsy if possible.
- Must be 18 years or older.
- Must be in good general health with specific blood counts and organ function levels.
- Must not have other active cancers or be receiving treatment for other cancers.
- Must not have severe heart problems.
- Must be able to swallow pills.
- Women must not be pregnant and must use birth control during the study and for 4 months after.
- Must be willing to sign a consent form and follow study procedures.
Exclusion Criteria
- Cannot be taking other experimental drugs.
- Cannot have allergies to similar drugs.
- Cannot take certain medications that interact with rogaratinib.
- Cannot have uncontrolled health issues or psychiatric conditions that affect study participation.
- Pregnant or breastfeeding women cannot participate.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| City of Hope Comprehensive Cancer Center | 91010 | Duarte | California |
| City of Hope at Irvine Lennar | 92618 | Irvine | California |
| UCHealth University of Colorado Hospital | 80045 | Aurora | Colorado |
| University of Miami Miller School of Medicine-Sylvester Cancer Center | 33136 | Miami | Florida |
| UM Sylvester Comprehensive Cancer Center at Plantation | 33324 | Plantation | Florida |
| Northwestern University | 60611 | Chicago | Illinois |
| National Cancer Institute Developmental Therapeutics Clinic | 20892 | Bethesda | Maryland |
| National Institutes of Health Clinical Center | 20892 | Bethesda | Maryland |
| Dana-Farber Cancer Institute | 02215 | Boston | Massachusetts |
| University of Michigan Rogel Cancer Center | 48109 | Ann Arbor | Michigan |
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