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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
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

Study Summary

This trial compares pazopanib hydrochloride to placebo in treating patients with kidney cancer that has spread and have no evidence of disease after surgery.

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.Check my eligibility
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.See study design
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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Disease-free Survival (DFS)
Secondary outcome measures
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
Other outcome measures
To Prospectively Bank Preserved Tissue From Primary Tumors and Associated Metastatic Sites in Patients With RCC

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
Pazopanib Hydrochloride
2009
Completed Phase 2
~820
Magnetic Resonance Imaging
2017
Completed Phase 3
~1190
Computed Tomography
2017
Completed Phase 2
~2720

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,687 Previous Clinical Trials
40,930,242 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people total have been asked to participate in this research?

"This particular trial is no longer searching for patients, as the last update was on June 23rd, 2022. However, if you are still seeking a clinical trial to participate in, there are 2664 trials for carcinoma and 25 Pazopanib Hydrochloride trials that are currently recruiting."

Answered by AI

Are we presently enrolling patients for this research?

"According to the clinicaltrials.gov website, this research is no longer actively recruiting patients as it has not been updated since June 23rd, 2020. This study was first posted on August 8th, 2012. Although this specific trial has completed recruitment, there are 2,689 other studies that have open enrolment at this time."

Answered by AI

Has there been research like this conducted before?

"Pazopanib Hydrochloride has been under medical scrutiny since 2011 when the first Novartis-sponsored study was published. Since then, there have been 25 active trials in 23 countries and 608 cities."

Answered by AI

Has Pazopanib Hydrochloride been cleared by the FDA?

"Pazopanib Hydrochloride is rated as a 3 in terms of safety by our team at Power. This means that there is some efficacy data supporting the drug and multiple rounds of data showing that it is safe."

Answered by AI

Can you share any other published studies on Pazopanib Hydrochloride?

"Pazopanib Hydrochloride was first studied at the University of Texas MD Anderson Cancer Center back in 2011. As of now, 561 studies have been completed with 25 more currently underway - many in Marshfield, Wisconsin."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Pazopanib Hydrochloride in Treating Patients With Metastatic Kidney Cancer Who Have No Evidence of Disease After Surgery
2012. "Pazopanib Hydrochloride in Treating Patients With Metastatic Kidney Cancer Who Have No Evidence of Disease After Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01575548.
All > Metastatic Renal Cell Carcinoma > Votrient
~10 spots leftby May 2025
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