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Kinase Inhibitor

Sunitinib for Cancer

Phase 2

Waitlist Available

Led By Lilian T Gien

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

Creatinine must be within normal institutional limits OR Creatinine clearance >= 60 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal

Patients must have an electrocardiogram (ECG) within 8 weeks prior to treatment assignment and must have no clinically important abnormalities in rhythm, conduction or morphology of resting ECG

Must not have

Serious or non-healing wound, ulcer, or bone fracture

Known hypersensitivity or excess toxicity from sunitinib or compounds of similar chemical composition or biologic effect

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Awards & highlights

No Placebo-Only Group

Summary

"This trial is testing how effective sunitinib is in treating cancer patients with specific genetic changes. Sunitinib is a type of medication that blocks mutated genes in cancer cells from multiplying, which

Who is the study for?

This trial is for cancer patients with a specific genetic change in the cKIT gene. It's open to those with lymphoma, multiple myeloma, or solid tumors who meet certain health standards. People are excluded if they don't have the cKIT mutation or if their health conditions make it unsafe to participate.

What is being tested?

The trial is testing Sunitinib, a kinase inhibitor medication that targets cancers with cKIT mutations. Patients will undergo various assessments including biopsies and imaging tests like MRI and CT scans to see how well the treatment works.

What are the potential side effects?

Sunitinib may cause side effects such as fatigue, nausea, mouth sores, high blood pressure, bleeding events, skin problems and can affect heart function which might be monitored through echocardiography.

Eligibility Criteria

Inclusion Criteria

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

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My kidney function is normal or meets the required levels for the study.

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My recent ECG showed no significant heart issues.

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My heart's pumping ability is within the normal range according to recent tests.

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My cancer has a specific genetic change but not in exon 17 or 18.

Exclusion Criteria

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

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I have a serious or non-healing wound, ulcer, or bone fracture.

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I am allergic or had a bad reaction to sunitinib or similar drugs.

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I have been treated with sunitinib before.

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I have not had severe bleeding in the last 4 weeks.

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My high blood pressure is not controlled by medication.

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My thyroid condition cannot be controlled with medication.

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I have brain metastases.

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I am taking strong or moderate drugs that affect liver enzyme levels.

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I am taking warfarin or similar blood thinners.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years 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 response rate (ORR)

Secondary study objectives

6-month progression free survival (PFS)

Overall survival

Progression free survival

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 (sunitinib)Experimental Treatment7 Interventions

Patients receive sunitinib PO QD on days 1-28 of each cycle. Cycles repeat every 42 days in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo CT or MRI during screening and on study, as well as during follow-up as clinically necessary. Patients also undergo ECHO or nuclear study throughout the trial as clinically necessary. Patients undergo biopsies and blood sample collection on study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Biopsy

2014

Completed Phase 4

~1150

Echocardiography

2013

Completed Phase 4

~11580