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Tyrosine Kinase Inhibitor

Rogaratinib for Sarcoma and Gastrointestinal Stromal Tumors

Phase 2

Waitlist Available

Led By Suzanne George

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age >= 18 years

Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)

Must not have

Concomitant administration of medications that prolong QT/QTc interval is prohibited in accordance with the published FDA guidance 'E14 Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs'

Patients with disturbed calcium and/or phosphate metabolism are excluded from this study

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 30 days after removal from study

Awards & highlights

No Placebo-Only Group

Summary

This trial studies the effect of rogaratinib in treating patients with sarcoma with a change in FGFRs or SDH-deficient GIST. Rogaratinib may stop growth of tumor cells by blocking enzymes needed for cell growth.

Who is the study for?

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.

What is being tested?

The 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.

What are the potential side effects?

While the document does not specify side effects of Rogaratinib, similar cancer drugs can cause fatigue, nausea, liver issues, risk of infection due to low blood counts and potential heart problems.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I can take care of myself but might not be able to do heavy physical work.

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I had hepatitis C but am cured, or I'm being treated with no detectable virus.

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My hepatitis B virus load is undetectable with treatment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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My calcium and phosphate levels are normal.

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I am allergic to medications similar to rogaratinib.

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I am not pregnant or breastfeeding.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 30 days after removal from study

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 30 days after removal from study

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 30 days after removal from study for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Objective radiographic response

Secondary study objectives

Incidence of adverse events

Progression-free survival

Other study objectives

Banking of tumor material, germline deoxyribonucleic acid, and peripheral blood

Mechanisms of resistance

Serial measurements of FGFR and FGFR ligand

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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 every 8 weeks. Patients may also undergo blood sample collection on study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Biospecimen Collection

2004

Completed Phase 3

~2030

Computed Tomography

2017

Completed Phase 2

~2790