Pazopanib Hydrochloride for Clear Cell Renal Cell Carcinoma

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
University of Pittsburgh Cancer Institute (UPCI), Pittsburgh, PAClear Cell Renal Cell Carcinoma+1 MorePazopanib Hydrochloride - Drug
Eligibility
18+
All Sexes
What conditions do you have?
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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

Eligible Conditions
  • Clear Cell Renal Cell Carcinoma
  • Stage IV Renal Cell Carcinoma

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 4 Secondary · Reporting Duration: At 12 months

At 12 months
PFS rate at 12 months (Phase II)
Day 29
Pazopanib exposure as measured by pharmacokinetics parameters
Day 30
Overall survival (Phase II)
Up to 140 days
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)
Day 30
IL-8 levels
Incidence of grade 3 or higher toxicities, graded according to CTCAE version 4.0
MDSC levels
Median PFS (Phase II)
Response rate according to RECIST 1.1 (Phase I)
VEGF levels

Trial Safety

Safety Progress

1 of 3

Trial Design

1 Treatment Group

Treatment (pazopanib hydrochloride and bevacizumab)
1 of 1

Experimental Treatment

51 Total Participants · 1 Treatment Group

Primary Treatment: Pazopanib Hydrochloride · No Placebo Group · Phase 1 & 2

Treatment (pazopanib hydrochloride and bevacizumab)Experimental Group · 4 Interventions: Bevacizumab, Pazopanib Hydrochloride, Pharmacological Study, Laboratory Biomarker Analysis · Intervention Types: Biological, Drug, Other, Other
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bevacizumab
FDA approved
Pazopanib
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: at 12 months

Who is running the clinical trial?

GlaxoSmithKlineIndustry Sponsor
4,657 Previous Clinical Trials
7,950,834 Total Patients Enrolled
Roswell Park Cancer InstituteLead Sponsor
381 Previous Clinical Trials
29,714 Total Patients Enrolled
Saby GeorgePrincipal InvestigatorRoswell Park Cancer Institute
5 Previous Clinical Trials
116 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 15 Total Inclusion Criteria

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Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.