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Pazopanib in Previously Treated Patients With Metastatic Renal Cell Carcinoma | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Pazopanib in Previously Treated Patients With Metastatic Renal Cell Carcinoma

A Phase II Trial of Pazopanib in Patients With Metastatic Renal Cell Carcinoma Previously Treated With Sunitinib or Bevacizumab

NCT00731211•SCRI Development Innovations, LLC

View on ClinicalTrials.gov

Summary

This is a Phase II, non-randomized, open-label, single-arm study in patients with metastatic renal cell carcinoma who have received one prior targeted therapy with either sunitinib or bevacizumab. The planned enrollment for this study is 60 patients.

Detailed Description

All eligible patients will receive 800 mg of pazopanib orally each day continuously. Patients will be re-evaluated for treatment response after 8 weeks of daily oral pazopanib therapy. Response to therapy will be assigned using RECIST criteria (Section 6.0) Patients who have objective response or stable disease will continue treatment with evaluations every 8 weeks, until the time of tumor progression or intolerable treatment-related side effects.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. All patients must have histologically documented metastatic or unresectable locally recurrent clear cell renal carcinoma. In patients with mixed histologies, any percentage of clear cell histology is acceptable.
•2. Patients must have had only one previous targeted agent therapy with either sunitinib or bevacizumab. Patients must have progressed either during or within 3 months of discontinuing treatment with one of these agents. Patients who stopped either sunitinib or bevacizumab because of unacceptable toxicity are also eligible.
•3. Patients may have received one previous regimen containing traditional immunotherapy (interferon, interleukin-2), chemotherapy, or combination chemoimmunotherapy for metastatic disease.
•4. Previous nephrectomy is required unless clinically contraindicated (e.g. extensive liver or bone metastases; primary tumor \<5cm).
•5. An ECOG performance status of 0 or 1.
•6. At least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as \>20 mm with conventional techniques, or as \>10 mm with spiral computerized tomography (CT) scan according to the Response Evaluation Criteria in Solid Tumors (RECIST).
•7. Absolute neutrophil count (ANC) \>1500; platelets \>75,000 (within 7 days prior to study treatment).
•8. Adequate liver function as measured by serum bilirubin \<1.5 mg/dL and AST/ALT \<2.5 times upper limit of normal (ULN) (or \<5 x ULN in patients with documented liver metastases).
•9. Serum creatinine \<2.0 mg/dL.
•10. Patients must be able to understand the nature of this study and give written informed consent.

Exclusion Criteria

•1. Previous treatment with more than one targeted agent, or more than one previous traditional regimen (e.g., chemotherapy, immunotherapy, chemoimmunotherapy).
•2. Previous treatment with sorafenib, temsirolimus, everolimus or other investigational targeted agents.
•3. Inability to swallow and retain oral medication.
•4. History of other malignancy. Patients who have been disease-free for 5 years, or patients with a history of completely resected non-melanoma skin cancer or successfully treated in situ carcinoma are eligible.
•5. Concurrent disease or condition that would make the patient inappropriate for study participation including: (1) any unresolved or unstable serious toxicity from prior administration of another drug, or (2) any serious medical disorder that would interfere with the patient's safety, obtaining informed consent, or compliance with the study.
•6. History or clinical evidence of central nervous system (CNS) metastases or leptomeningeal carcinomatosis, except for individuals who have previously treated parenchymal CNS metastases, are asymptomatic, and have had no requirement for steroids or anticonvulsants for \>2 months prior to study enrollment. Routine screening with CNS imaging studies (computed tomography \[CT\] or magnetic resonance imaging \[MRI\]) is required only if clinically indicated, or if the patient has a history of CNS metastases.
•7. Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel.
•8. Active peptic ulcer disease, inflammatory bowel disease, or other gastrointestinal condition increasing the risk of perforation.
•9. History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 4 weeks prior to beginning therapy.
•10. Presence of uncontrolled infection.
+19 more criteria

Locations (17)

San Francisco Oncology Associates

San Francisco, California, United States

Florida Cancer Specialists

Fort Myers, Florida, United States

Watson Clinic Center for Cancer Care and Research

Lakeland, Florida, United States

Florida Hospital Cancer Institute

Orlando, Florida, United States

Gulfcoast Oncology Associates

St. Petersburg, Florida, United States

Medical Oncology Associates of Augusta

Augusta, Georgia, United States

Northeast Georgia Medical Center

Gainesville, Georgia, United States

Baptist Hospital East

Louisville, Kentucky, United States

Central Maine Medical Center

Lewiston, Maine, United States

Grand Rapids Clinical Oncology Program

Grand Rapids, Michigan, United States

Key Dates

Start Date

September 1, 2008

Primary Completion Date

May 1, 2011

Completion Date

September 1, 2012

Last Updated

May 20, 2015

Enrollment

ACTUAL participants

Conditions

Renal Cell Carcinoma

Interventions

Pazopanib

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 20, 2015Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Pazopanib in Previously Treated Patients With Metastatic Renal Cell Carcinoma

Inclusion Criteria

Exclusion Criteria

Association Between Galectin-3 Levels and Outcomes in Patients With Renal Cell Carcinoma, Transitional Cell Carcinoma , Non Small Cell Lung Cancer, and Hepatocellular Carcinoma, Treated With PD-1/PDL-1 Inhibitors

Ketogenic Dietary Intervention to Improve Response to Immunotherapy in Patients With Metastatic Melanoma and Metastatic Kidney Cancer

Neoadjuvant of Axitinib Plus PD-1 to Improve Disease Free Survival of Patients With Renal Cell Carcinoma

A Clinical Study of Belzutifan and Zanzalintinib in People With Recurrent Kidney Cancer Following Adjuvant Therapy (MK-6482-033)

Immune Checkpoint Inhibitor Response in Solid Tumors Using a Live Tumor Diagnostic Platform

Open-Label Phase 1/2 Study of NEO-811 in Subjects With Locally Advanced or Metastatic Non-Resectable Clear Cell Renal Cell Carcinoma