Pazopanib Hydrochloride in Treating Patients With Metastatic Kidney Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01767636|
Recruitment Status : Active, not recruiting
First Posted : January 14, 2013
Last Update Posted : May 30, 2018
|Condition or disease||Intervention/treatment||Phase|
|Carcinoma of the Collecting Ducts of Bellini Chromophobe Renal Cell Carcinoma Kidney Medullary Carcinoma Kidney Oncocytoma Metastatic Renal Cell Cancer Papillary Renal Cell Carcinoma Recurrent Renal Cell Carcinoma Sarcomatoid Renal Cell Carcinoma Stage IV Renal Cell Cancer||Drug: Pazopanib Hydrochloride||Phase 2|
I. To determine the efficacy of pazopanib hydrochloride (pazopanib) in non clear cell metastatic renal cell cancer patients as assessed by the overall survival rate at 12 months.
I. To determine the rates of best tumor response at the end of the first two treatment cycles of pazopanib in non clear cell metastatic renal cell cancer patients.
II. To determine the benefit of pazopanib in increasing progression free survival time.
III. To describe toxicity profile of pazopanib in non clear cell metastatic renal cell cancer patients.
Patients receive pazopanib hydrochloride orally (PO) once daily (QD) on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for 2 years.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||38 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Efficacy Trial of Pazopanib in Non-clear Cell Metastatic Renal Cell Cancer (mRCC) PINCR|
|Actual Study Start Date :||May 16, 2013|
|Estimated Primary Completion Date :||May 16, 2019|
|Estimated Study Completion Date :||May 16, 2019|
Experimental: Treatment (pazopanib hydrochloride)
Patients receive pazopanib hydrochloride PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Drug: Pazopanib Hydrochloride
- Overall survival rate [ Time Frame: 12 months ]A "12-month overall survivor" will be considered synonymous with "success". The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. Confidence intervals for the true success proportion will be calculated.
- Adverse event rate, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 [ Time Frame: Up to 2 years ]The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine patterns.
- Progression-free survival [ Time Frame: From registration to the earliest date documentation of disease progression or death, assessed up to 2 years ]Kaplan-Meier curve will be used to estimate progression-free survival time.
- Retreatment of patients who have relapsed [ Time Frame: Up to 2 years ]Statistical analysis of the observational phase data for these patients will be of a descriptive nature.
- Tumor response rate, according to the Response Evaluation Criteria in Solid Tumors version 1.1 [ Time Frame: Up to 2 years ]A tumor response is defined to be a complete response or partial response noted as the objective status on 2 consecutive evaluations at least 8 weeks apart.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01767636
|United States, Arizona|
|Mayo Clinic in Arizona|
|Scottsdale, Arizona, United States, 85259|
|United States, Florida|
|Mayo Clinic in Florida|
|Jacksonville, Florida, United States, 32224-9980|
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||Brian Costello||Mayo Clinic|