Rogaratinib for Sarcoma and Gastrointestinal Stromal Tumors

Recruiting in Palo Alto (17 mi)

+18 other locations

Overseen bySuzanne George

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: National Cancer Institute (NCI)

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This phase II trial studies the effect of rogaratinib in treating patients with sarcoma with a change in a group of proteins called fibroblast growth factor receptors (FGFRs) or SDH-deficient gastrointestinal stromal tumor (GIST). Rogaratinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Research Team

Suzanne George

Principal Investigator

Dana-Farber - Harvard Cancer Center LAO

Eligibility Criteria

Adults with advanced sarcoma showing FGFR alterations or SDH-deficient GIST, not suitable for surgery. Must have measurable disease, acceptable organ function, and be willing to undergo a biopsy if safe. Excludes those with certain viral infections unless treated, pregnant women, and individuals on medications that interact with Rogaratinib.

Inclusion Criteria

Participant is willing to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up

Absolute neutrophil count >= 1,000/mcL

Platelets >= 100,000/mcL

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Exclusion Criteria

Patients with uncontrolled intercurrent illness

You are not currently taking any experimental drugs or treatments.

I am not taking any medications that affect my heart's electrical cycle.

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Treatment Details

Interventions

Rogaratinib (Tyrosine Kinase Inhibitor)

Trial OverviewThe trial is testing Rogaratinib's effectiveness in halting tumor growth by blocking enzymes needed for cell growth in patients with specific protein changes in their sarcomas or who have a particular type of GIST.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Treatment (rogaratinib)Experimental Treatment6 Interventions

Patients receive rogaratinib PO BID on days 1-28 of each cycle. Treatment repeats every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo biopsy at baseline and progression and CT, MRI, and PET-CT throughout the study. Patients may also undergo blood sample collection on study.