What side effects are associated with this type of intervention?

Common side effects of treatments for Renal Cell Carcinoma, particularly those involving enzyme inhibition and anti-angiogenesis like Pazopanib Hydrochloride, include hypertension, diarrhea, hypothyroidism, and liver toxicity. Patients may also experience fatigue, hand-foot syndrome, and gastrointestinal disturbances. Severe but less common side effects can include cardiac issues such as decreased ventricular ejection fraction and venous thromboembolism.

What prior FDA approvals exist?

For the treatment of Renal Cell Carcinoma (RCC), the FDA has approved several drugs that function through enzyme inhibition and anti-angiogenesis, similar to Pazopanib Hydrochloride. These include Sunitinib and Sorafenib, which are tyrosine kinase inhibitors targeting vascular endothelial growth factor receptors (VEGFR) and other pathways to inhibit tumor growth and angiogenesis. Additionally, Axitinib and Cabozantinib have been approved for their roles in targeting multiple tyrosine kinases involved in tumor proliferation and blood vessel formation. These drugs have shown efficacy in managing advanced RCC by disrupting the blood supply to tumors and inhibiting critical growth pathways.

What other types of research exist?

Promising novel alternatives to Pazopanib Hydrochloride for RCC patients in 2024 include: 1) Pembrolizumab plus Axitinib, which combines an immune checkpoint inhibitor with a tyrosine kinase inhibitor, showing improved progression-free survival and overall survival. 2) Nivolumab plus Ipilimumab, an immunotherapy combination that has demonstrated significant efficacy in advanced RCC. 3) Lenvatinib plus Pembrolizumab, another combination therapy that targets both angiogenesis and immune checkpoints, showing promising results in clinical trials.

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Tyrosine Kinase Inhibitor

Pazopanib for Renal Cell Carcinoma

Q: What is the mechanism of action of this treatment?

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.

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

Pivotal Trial

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 weeks3 visits

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

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

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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

0 / 10Eligibility criteria met

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.