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Monoclonal Antibodies

Pazopanib + Bevacizumab for Kidney Cancer

Phase 1 & 2
Waitlist Available
Led By Saby George
Research Sponsored by Roswell Park Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Ability to swallow and retain oral medication
Biopsy/pathology-proven clear cell renal cell carcinoma (CCRCC) with metastases
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 12 months
Awards & highlights

Study Summary

This trial is studying the side effects and best dosage of two drugs, pazopanib hydrochloride and bevacizumab, to treat patients with metastatic kidney cancer that has not been previously treated. Pazopanib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Bevacizumab is a monoclonal antibody that can prevent tumor growth by blocking the ability of tumor cells to grow and spread. Giving pazopanib hydrochloride together with bevacizumab may kill more tumor

Who is the study for?
This trial is for adults with clear cell renal cell carcinoma that has spread, who are in good physical condition (ECOG <=1), have not had certain other cancers or major surgeries recently, and do not have brain metastases or serious cardiovascular conditions. They must be able to take oral medication and agree to use birth control if of childbearing potential.Check my eligibility
What is being tested?
The study is testing the combination of Pazopanib Hydrochloride, a drug that may block tumor growth by inhibiting enzymes and blood flow to the tumor, with Bevacizumab, an antibody that can prevent tumors from growing. The phase I/II trial aims to determine the best dose and how well these drugs work together against metastatic kidney cancer.See study design
What are the potential side effects?
Possible side effects include high blood pressure, fatigue, diarrhea, changes in hair color, nausea or vomiting. More severe risks involve liver problems like hepatitis B reactivation or liver failure; heart issues such as heart failure; bleeding events; thyroid dysfunction; wound healing complications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can swallow and keep down pills.
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My kidney cancer has spread and was confirmed by a biopsy.
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I am fully active and can carry on all pre-disease activities without restriction.
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My kidney function is normal or meets the required levels.
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My heart pumps well, with an ejection fraction over 50%.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Median PFS (Phase II)
Optimal phase II dose, defined as the largest dose level at which less than 2 out of the 6 patients experienced dose-limiting toxicity, graded according to Common Terminology Criteria for Adverse Events version 4.0 (Phase I)
Secondary outcome measures
Incidence of grade 3 or higher toxicities, graded according to CTCAE version 4.0
Overall survival (Phase II)
PFS rate at 12 months (Phase II)
+1 more
Other outcome measures
IL-8 levels
MDSC levels
Pazopanib exposure as measured by pharmacokinetics parameters
+1 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (pazopanib hydrochloride and bevacizumab)Experimental Treatment4 Interventions
Patients receive pazopanib hydrochloride PO on days 1-28 and bevacizumab IV over 30-90 minutes on days 36 and 50. Courses repeat every 70 days in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pazopanib Hydrochloride
2009
Completed Phase 2
~820
Bevacizumab
2013
Completed Phase 4
~5280

Find a Location

Who is running the clinical trial?

Roswell Park Cancer InstituteLead Sponsor
402 Previous Clinical Trials
30,807 Total Patients Enrolled
GlaxoSmithKlineIndustry Sponsor
4,750 Previous Clinical Trials
8,067,401 Total Patients Enrolled
Saby GeorgePrincipal InvestigatorRoswell Park Cancer Institute
5 Previous Clinical Trials
116 Total Patients Enrolled

Media Library

Bevacizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT01684397 — Phase 1 & 2
Renal Cell Carcinoma Research Study Groups: Treatment (pazopanib hydrochloride and bevacizumab)
Renal Cell Carcinoma Clinical Trial 2023: Bevacizumab Highlights & Side Effects. Trial Name: NCT01684397 — Phase 1 & 2
Bevacizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01684397 — Phase 1 & 2

Frequently Asked Questions

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

What is the scientific community's previous experience with Pazopanib Hydrochloride?

"Pazopanib Hydrochloride was first studied in the year 2004 at Memoral Sloan Kettering Basking Ridge (Follow Up Only). As of now, there have been a total of 1719 completed clinical trials. Additionally, there are currently 401 live studies, with a considerable amount of these studies taking place in Pittsburgh, Pennsylvania."

Answered by AI

Are there several inpatient facilities conducting this research project in North America?

"There are a total of 5 sites where this clinical trial is taking place. The University of Pittsburgh Cancer Institute (UPCI) in Pittsburgh, the Medical College of Wisconsin in Milwaukee, and the Karamanos Cancer Institute in Detroit are 3 of these sites."

Answered by AI

What purpose does Pazopanib Hydrochloride usually serve?

"Pazopanib Hydrochloride is most often used as a treatment for malignant neoplasms. However, this medication can also be effective in managing recurrent platinum sensitive primary peritoneal cancer, advanced thyroid cancer, and stage iv epithelial ovarian cancer that has had initial surgical resection."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Pazopanib Hydrochloride and Bevacizumab in Treating Patients With Previously Untreated Metastatic Kidney Cancer
2012. "Pazopanib Hydrochloride and Bevacizumab in Treating Patients With Previously Untreated Metastatic Kidney Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01684397.
All > Basal Cell Carcinoma > Paid Studies Wisconsin
~3 spots leftby Jan 2025
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