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
1 other identifier
interventional
57
1 country
17
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Sep 2008
Typical duration for phase_2
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 5, 2008
CompletedFirst Posted
Study publicly available on registry
August 8, 2008
CompletedStudy Start
First participant enrolled
September 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2012
CompletedResults Posted
Study results publicly available
May 20, 2015
CompletedMay 20, 2015
May 1, 2015
2.7 years
August 5, 2008
December 16, 2014
May 18, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall Response Rate
Proportion of patients with complete and partial response (CR and PR). CR defined as disappearance of target lesions; PR defined as at least a 30% decrease in the sum of the longest diamater of target lesions.
18 months
Secondary Outcomes (1)
Progression-free Survival
every 8 weeks until progressive disease, expected average of 18 months
Study Arms (1)
Pazopanib
EXPERIMENTAL800 mg of pazopanib orally each day continuously
Interventions
Eligibility Criteria
You may qualify if:
- 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.
- 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.
- Patients may have received one previous regimen containing traditional immunotherapy (interferon, interleukin-2), chemotherapy, or combination chemoimmunotherapy for metastatic disease.
- Previous nephrectomy is required unless clinically contraindicated (e.g. extensive liver or bone metastases; primary tumor \<5cm).
- An ECOG performance status of 0 or 1.
- 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).
- Absolute neutrophil count (ANC) \>1500; platelets \>75,000 (within 7 days prior to study treatment).
- 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).
- Serum creatinine \<2.0 mg/dL.
- Patients must be able to understand the nature of this study and give written informed consent.
You may not qualify if:
- Previous treatment with more than one targeted agent, or more than one previous traditional regimen (e.g., chemotherapy, immunotherapy, chemoimmunotherapy).
- Previous treatment with sorafenib, temsirolimus, everolimus or other investigational targeted agents.
- Inability to swallow and retain oral medication.
- 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.
- 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.
- 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.
- Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel.
- Active peptic ulcer disease, inflammatory bowel disease, or other gastrointestinal condition increasing the risk of perforation.
- History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 4 weeks prior to beginning therapy.
- Presence of uncontrolled infection.
- Concurrent cancer therapy (e.g., chemotherapy, radiation therapy, surgery, immunotherapy, biologic therapy, hormonal therapy, or tumor embolization).
- Concurrent treatment with an investigational agent or participation in another clinical trial.
- Use of an investigational anti-cancer drug within 30 days or 5 half-lives, whichever is longer, preceding the first dose of pazopanib.
- Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to pazopanib.
- Has taken or is taking prohibited medications.
- +14 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- SCRI Development Innovations, LLClead
- GlaxoSmithKlinecollaborator
Study Sites (17)
San Francisco Oncology Associates
San Francisco, California, 94115, United States
Florida Cancer Specialists
Fort Myers, Florida, 33901, United States
Watson Clinic Center for Cancer Care and Research
Lakeland, Florida, 33805, United States
Florida Hospital Cancer Institute
Orlando, Florida, 32804, United States
Gulfcoast Oncology Associates
St. Petersburg, Florida, 33705, United States
Medical Oncology Associates of Augusta
Augusta, Georgia, 30901, United States
Northeast Georgia Medical Center
Gainesville, Georgia, 30501, United States
Baptist Hospital East
Louisville, Kentucky, 40207, United States
Central Maine Medical Center
Lewiston, Maine, 04240, United States
Grand Rapids Clinical Oncology Program
Grand Rapids, Michigan, 49503, United States
St. Louis Cancer Care
Chesterfield, Missouri, 63017, United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198, United States
Oncology Hematology Care
Cincinnati, Ohio, 45242, United States
South Carolina Oncology Associates, PA
Columbia, South Carolina, 29210, United States
Chattanooga Oncology Hematology Associates
Chattanooga, Tennessee, 37404, United States
Tennessee Oncology, PLLC
Nashville, Tennessee, 37023, United States
Virginia Cancer Institute
Richmond, Virginia, 23235, United States
Related Publications (1)
Hainsworth JD, Rubin MS, Arrowsmith ER, Khatcheressian J, Crane EJ, Franco LA. Pazopanib as second-line treatment after sunitinib or bevacizumab in patients with advanced renal cell carcinoma: a Sarah Cannon Oncology Research Consortium Phase II Trial. Clin Genitourin Cancer. 2013 Sep;11(3):270-5. doi: 10.1016/j.clgc.2013.04.006. Epub 2013 May 9.
PMID: 23665131RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- John D. Hainsworth, MD
- Organization
- Sarah Cannon Research Institute
Study Officials
- STUDY CHAIR
John D Hainsworth, M.D.
SCRI Development Innovations, LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 5, 2008
First Posted
August 8, 2008
Study Start
September 1, 2008
Primary Completion
May 1, 2011
Study Completion
September 1, 2012
Last Updated
May 20, 2015
Results First Posted
May 20, 2015
Record last verified: 2015-05