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Tyrosine Kinase Inhibitor

Cabozantinib vs Sunitinib for Kidney Cancer

Phase 2

Waitlist Available

Led By Matthew T Campbell

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

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

Must have

The subject has organ and marrow function and laboratory values as follows within 4 days before the first dose of cabozantinib or sunitinib: a.The ANC >/= 1500/mm^3 without colony stimulating factor support; b.White blood cell count >/= 2500/mm^3 (>/= 2.5 GI/L). c.Platelets >/=100,000/mm^3; d.Hemoglobin >/= 9 g/dL; e. Bilirubin </= 1.5 x the ULN. For subjects with known Gilbert's disease, bilirubin </= 3.0 mg/dL; f.Serum albumin >/= 2.8 g/dl g.Serum creatinine </= 2.0 X ULN or calculated creatinine clearance >/= 30 mL/min (>/= 0.5 mL/sec) using the Cockcroft-Gault equation: Males: (140 - age) x weight (kg)/(serum creatinine [mg/dL] × 72) Females: [(140 - age) x weight (kg)/(serum creatinine [mg/dL] × 72)] × 0.85 h.Alanine aminotransferase (ALT), aspartate aminotransferase (AST), and alkaline phosphatase (ALP) </= 3 X upper limit of normal (ULN). ALP </= 5 X ULN with documented bone metastases. i.Urine protein/creatinine ratio (UPCR) </= 1 mg/mg (</= 113.2 mg/mmol);

The subject is >/=18 years old on the day of consent;

Must not have

The subject has a variant histology that includes renal medullary carcinoma or collecting duct renal cell carcinoma. Any clear cell component in the tumor will lead to exclusion.

Major surgery (eg, GI surgery, removal or biopsy of brain metastasis) within 8 weeks before first dose of study treatment. Complete wound healing from major surgery must have occurred 1 month before first dose and from minor surgery (eg, simple excision, tooth extraction) at least 10 days before first dose. Subjects with clinically relevant ongoing complications from prior surgery are not eligible.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from randomization up to the time of disease progression or death up to two years

Awards & highlights

No Placebo-Only Group

Summary

This trial will compare the safety and effectiveness of two drugs for kidney cancer.

Who is the study for?

This trial is for adults with a specific type of kidney cancer that has spread and may have had one prior treatment excluding certain drugs. They should be in good physical condition, not pregnant, able to follow the study plan, and willing to use contraception. People with certain medical conditions or who've taken specific treatments recently can't join.

What is being tested?

The trial aims to compare the safety and effectiveness of two FDA-approved drugs for advanced kidney cancer: cabozantinib and sunitinib malate. Participants will receive either drug to determine which works better against this particular form of cancer.

What are the potential side effects?

Potential side effects include high blood pressure, fatigue, diarrhea, hand-foot syndrome (redness and pain on palms or soles), mouth sores, altered taste sensation, nausea/vomiting, decreased appetite/weight loss, hair color changes.

Eligibility Criteria

Inclusion Criteria

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

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Before starting the medication, your blood and organ function need to be within certain levels. For example, your white blood cell count needs to be at least 2500/mm^3, and your bilirubin levels need to be below a certain number.

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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 agree to use two forms of birth control during the study and for 4 months after.

Exclusion Criteria

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

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My kidney cancer is a specific type without any clear cell components.

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I have fully healed from any major surgery 1 month before starting the treatment and have no ongoing complications.

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I have previously been treated with drugs that stop the formation of new blood vessels in tumors, including cabozantinib.

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I haven't had recent radiation for bone metastasis or other radiation treatments.

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I have had brain metastases treated and stable for 4 weeks, and I'm not on steroids.

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I do not have serious heart issues, uncontrolled high blood pressure, or recent major cardiovascular events.

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I have serious stomach or intestine problems, including recent surgery complications.

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I have not had significant bleeding or serious wounds, and my liver and thyroid function are stable.

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My heart's electrical activity, measured by QTcF, is not over 500 ms.

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I cannot swallow pills.

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I need ongoing treatment with certain strong medications.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from randomization to death or last contact if still alive up to two years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from randomization to death or last contact if still alive up to two years

This trial's timeline: 3 weeks for screening, Varies for treatment, and from randomization to death or last contact if still alive up to two 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

Progression-Free Survival (PFS) Evaluated Using RECIST 1.1 Criteria

Secondary study objectives

Adverse Event Rates

Objective Response Rate (ORR) Evaluated Using RECIST 1.1 Criteria

Overall Survival (OS)

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Group I: Group 2 (sunitinib malate)Experimental Treatment1 Intervention

Participants receive sunitinib malate PO QD on days 1-28. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.

Group II: Group 1 (cabozantinib)Experimental Treatment1 Intervention

Participants receive cabozantinib PO QD on days 1-42. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cabozantinib

2020

Completed Phase 2

~1760

Sunitinib Malate

2008