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Tyrosine Kinase Inhibitor
Pazopanib for Kidney Cancer
Phase 2
Waitlist Available
Led By Brian Costello, M.D.
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Histological confirmation of non-clear cell renal cancer (including chromophilic [papillary], chromophobic, oncocytic, sarcomatoid, collecting duct [Bellini's duct]), translocation-type carcinoma or medullary renal cell carcinoma
Up to one prior treatment for metastatic non clear cell carcinoma is allowed prior to registration as long as the agent used to treat was not pazopanib
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
Study Summary
This trial looks at how well pazopanib hydrochloride works in treating patients with metastatic kidney cancer. Pazopanib hydrochloride may stop the growth of tumor cells and kidney cancer by blocking some of the enzymes needed for cell growth and blood flow to the tumor.
Who is the study for?
This trial is for patients with metastatic kidney cancer, including various non-clear cell types. Participants can have had one prior treatment (not pazopanib), must be able to consent and follow the study plan, and need a certain level of overall health and organ function. Pregnant or nursing women, those unwilling to use contraception, or individuals with specific health issues like CNS metastases are excluded.Check my eligibility
What is being tested?
The effectiveness of Pazopanib Hydrochloride is being tested in this phase II trial on patients with metastatic kidney cancer. The drug aims to inhibit tumor growth by blocking enzymes needed for cell growth and cutting off blood supply to the tumor.See study design
What are the potential side effects?
Pazopanib may cause liver problems, high blood pressure, diarrhea, hair color changes, nausea or vomiting. It could also lead to heart issues or bleeding events. Side effects vary from person to person.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My kidney cancer is not the common 'clear cell' type.
Select...
I have had one treatment for my cancer that has spread, but it wasn't with pazopanib.
Select...
I can take care of myself and am up and about more than half of my waking hours.
Select...
My cancer has spread, and it can be measured or seen on tests.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall Survival Rate at 12 Months
Secondary outcome measures
Number of Participants Experiencing at Least One Toxicity
Number of Participants With Best Response in the First 2 Cycles
Overall Survival
+1 moreSide effects data
From 2016 Phase 2 trial • 22 Patients • NCT0124757179%
Nausea
74%
Fatigue
68%
Diarrhea
53%
Neutrophil Count Decreased
53%
White Blood Cell Decreased
53%
Hypertension
47%
Anemia
42%
Vomiting
42%
Peripheral Sensory Neuropathy
37%
Constipation
37%
Abdominal Pain
32%
Anorexia
32%
Headache
32%
Dyspnea
26%
Cough
21%
Weight Loss
21%
Alopecia
21%
Alanine Aminotransferase Increased
21%
Hyponatremia
21%
Hypoalbuminemia
21%
Pain In Extremity
21%
Depression
21%
Aspartate Aminotransferase Increased
16%
Blurred Vision
16%
Dysphagia
16%
Blood Bilirubin Increased
16%
Dry Mouth
16%
Alkaline Phosphatase Increased
16%
Hypomagnesemia
16%
Hypocalcemia
16%
Arthralgia
16%
Memory Impairment
16%
Insomnia
16%
Epistaxis
11%
Creatinine Increased
11%
Rectal Hemorrhage
11%
Hearing Impaired
11%
Platelet Count Decreased
11%
Gastroesophageal Reflux Disease
11%
Tinnitus
11%
Hypokalemia
11%
Hypoglycemia
11%
Hyperglycemia
11%
Neck Pain
11%
Generalized Muscle Weakness
11%
Dizziness
11%
Anxiety
11%
Vaginal Hemorrhage
11%
Vaginal Discharge
11%
Rash Maculo-Papular
11%
Skin Hypopigmentation
11%
Urinary Frequency
5%
Ear Pain
5%
Ascites
5%
Lymphocyte Count Decreased
5%
Dyspepsia
5%
Bloating
5%
Oral Pain
5%
Fever
5%
Bruising
5%
Gastrointestinal Pain
5%
Sinus Bradycardia
5%
Sepsis
5%
Sinusitis
5%
Flatulence
5%
Pain
5%
Investigations - Other
5%
Proctitis
5%
Death Nos
5%
Sinus Tachycardia
5%
Reproductive System And Breast Disorders - Other
5%
Mucositis Oral
5%
Edema Trunk
5%
Edema Limbs
5%
Urinary Tract Infection
5%
Dehydration
5%
Back Pain
5%
Arthritis
5%
Paresthesia
5%
Dysgeusia
5%
Urinary Retention
5%
Pelvic Pain
5%
Allergic Rhinitis
5%
Skin And Subcutaneous Tissue Disorders - Other
5%
Nail Discoloration
5%
Dry Skin
5%
Proteinuria
100%
80%
60%
40%
20%
0%
Study treatment Arm
Pazopanib
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (pazopanib hydrochloride)Experimental Treatment1 Intervention
Patients receive pazopanib hydrochloride PO QD on days 1-28. Courses repeat every 28 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
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,658 Previous Clinical Trials
40,924,451 Total Patients Enrolled
Mayo ClinicLead Sponsor
3,207 Previous Clinical Trials
3,767,102 Total Patients Enrolled
Brian Costello, M.D.Principal InvestigatorMayo Clinic
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am of childbearing age and do not plan to use birth control.I do not have any severe illnesses besides my current condition.I do not have any uncontrolled illnesses.My heart and lungs are healthy, and I am not on any conflicting medications.I can take care of myself and am up and about more than half of my waking hours.Your blood counts and chemistry need to be within certain ranges.I am currently breastfeeding.I have not had a stroke, heart attack, blood clot in my lung or untreated blood clot in my vein recently.I am immunocompromised due to conditions other than corticosteroid use, including HIV.I have stomach or intestine problems that could cause bleeding.My kidney cancer is not the common 'clear cell' type.I have had one treatment for my cancer that has spread, but it wasn't with pazopanib.I have not had any other cancer within the last 5 years.I am using effective birth control or am not of childbearing potential.I have been treated with pazopanib before.My cancer has spread to my brain or spinal cord.My cancer has spread, and it can be measured or seen on tests.I have stomach or intestine problems that could affect how I absorb medication.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (pazopanib hydrochloride)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the Federal Drug Administration greenlit Pazopanib Hydrochloride?
"The safety of Pazopanib Hydrochloride was evaluated as a 2 due to the existence of preliminary evidence that supports its safety, but not its efficacy."
Answered by AI
Has this trial been previously attempted elsewhere?
"Currently, 24 ongoing trials for Pazopanib Hydrochloride are being conducted in 608 cities and 23 countries. This drug was first tested by Novartis back in 2011 with a Phase 2 clinical trial involving 180 participants. Since then, 163 additional studies have been carried out."
Answered by AI
What is the current status of participation for this research endeavor?
"As gleaned from clinicaltrials.gov, the recruitment period for this trial has expired; it was initially posted on May 16th 2013 and modified most recently on June 16th 2022. Despite no longer recruiting patients, 2608 other trials are still in need of participants."
Answered by AI
How is the eligibility criteria being applied to determine those who can participate in this experiment?
"This study is no longer accepting participants. It was initially posted on May 16th 2013 and the last update occured June 16th 2022. If you are looking for other medical studies, there exist 2584 trials seeking patients with chromophobe renal cell carcinoma as well 24 more recruiting people to take Pazopanib Hydrochloride."
Answered by AI
Has Pazopanib Hydrochloride been explored in other trials prior to this one?
"Pazopanib Hydrochloride was initially studied in 2011 by researchers at University of Texas MD Anderson Cancer Center. Since then, 163 trials have been concluded and 24 are still ongoing; many of which take place in Jacksonville, Florida."
Answered by AI
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