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Tyrosine Kinase Inhibitor

Pazopanib for Renal Cell Carcinoma

Phase 3
Waitlist Available
Led By Leonard J Appleman
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
Patient must have a corrected QT (QTc) interval on electrocardiogram (ECG) =< 0.48 seconds by Bazett's calculation (=< Common Terminology Criteria for Adverse Events [CTCAE] version [v.]4 grade 2) prior to randomization
Patient must have pathologically confirmed renal cell carcinoma with a clear cell component; pure papillary and chromophobe histologies are excluded; there must be pathologic confirmation of metastatic disease in the resected metastasectomy specimen
Must not have
Taking drugs known to prolong the QTc interval; such drugs should be discontinued at least 5 half-lives prior to randomization
History of hemoptysis in excess of 2.5 mL (1/2 teaspoon) within 8 weeks prior to randomization
Timeline
Screening 3 weeks
Treatment Varies
Follow Up assessed every 3 months for the first 2 years, every 6 months for the next 3 years, and then annually up to 6 years
Awards & highlights

Summary

This trial is testing whether pazopanib hydrochloride can help prevent the return of kidney cancer in patients who have had surgery to remove it. The medication aims to stop cancer cell growth and block blood flow to tumors. Patients will take the drug for several months and be monitored frequently. Pazopanib has been approved for treating kidney cancer since 2009.

Who is the study for?
This trial is for patients with metastatic kidney cancer who've had surgery to remove all detectable disease. They should be in good physical condition, able to swallow pills without gastrointestinal issues, and have no remaining signs of cancer on scans. Women must not be pregnant and participants need effective contraception.
What is being tested?
The study compares pazopanib hydrochloride, a drug that may prevent tumor growth by blocking enzymes and blood flow to tumors, against a placebo. It's randomized: patients are put into the treatment or placebo group by chance.
What are the potential side effects?
Pazopanib can cause liver problems, high blood pressure, diarrhea, hair color changes, nausea or vomiting. It might also affect heart rhythm (QTc prolongation) and could lead to unusual bleeding.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My heart's electrical activity, measured by ECG, is within a safe range.
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My kidney cancer is confirmed and has spread, but it's not purely papillary or chromophobe type.
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My recent scans show no signs of cancer.
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I can swallow pills and don’t have issues absorbing food or medicine.
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I am fully active or restricted in physically strenuous activity but can do light work.
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I have had surgery to remove kidney cancer.
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My initial cancer diagnosis included cancer that had spread to distant parts of my body.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have stopped taking any medication that affects my heart's rhythm for a specific period before joining the study.
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I have not coughed up more than a half teaspoon of blood in the last 8 weeks.
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I am currently taking strong CYP3A4 inhibitors.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~assessed every 3 months for the first 2 years, every 6 months for the next 3 years, then annually up to 10 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed every 3 months for the first 2 years, every 6 months for the next 3 years, then annually up to 10 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
Disease-free Survival (DFS)
Secondary study objectives
3-year Overall Survival (OS) Rate
Change in Functional Assessment of Cancer Therapy-Kidney Symptom Index Score From Baseline to 6 Months
Change in Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Score From Baseline to 6 Months
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Arm A (Pazopanib)Experimental Treatment4 Interventions
Patients receive pazopanib hydrochloride PO QD on days 1-28. Treatment repeats every 28 days for up to 13 courses in the absence of disease progression or unacceptable toxicity. Patients also undergo CT or MRI throughout the study.
Group II: Arm B (Placebo)Placebo Group4 Interventions
Patients receive placebo PO QD on days 1-28. Treatment repeats every 28 days for up to 13 courses in the absence of disease progression or unacceptable toxicity. Patients also undergo CT or MRI throughout the study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Magnetic Resonance Imaging
2017
Completed Phase 3
~1160
Computed Tomography
2017
Completed Phase 2
~2740
Pazopanib Hydrochloride
2009
Completed Phase 2
~820

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Renal Cell Carcinoma (RCC) often involve enzyme inhibition and anti-angiogenesis. Drugs like Pazopanib Hydrochloride inhibit tyrosine kinases, which are enzymes that play a crucial role in the signaling pathways that regulate cell growth and blood vessel formation. By blocking these enzymes, these treatments can prevent the growth and spread of cancer cells. Additionally, anti-angiogenic agents target the vascular endothelial growth factor (VEGF) pathway, reducing the blood supply to tumors and thereby inhibiting their growth. These mechanisms are vital for RCC patients as they directly interfere with the cancer's ability to grow and metastasize, offering a targeted approach to treatment that can improve outcomes and potentially extend survival.

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,842 Previous Clinical Trials
41,002,871 Total Patients Enrolled
Leonard J ApplemanPrincipal InvestigatorECOG-ACRIN Cancer Research Group

Media Library

Pazopanib Hydrochloride (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT01575548 — Phase 3
Renal Cell Carcinoma Research Study Groups: Arm A (Pazopanib), Arm B (Placebo)
Renal Cell Carcinoma Clinical Trial 2023: Pazopanib Hydrochloride Highlights & Side Effects. Trial Name: NCT01575548 — Phase 3
Pazopanib Hydrochloride (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01575548 — Phase 3
~10 spots leftby Sep 2025