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Tyrosine Kinase Inhibitor

Pazopanib for Kidney Cancer

Phase 2

Waitlist Available

Led By Brian Costello

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

Must not have

Clinically significant gastrointestinal abnormalities that may increase the risk for gastrointestinal bleeding

Men or women of childbearing potential who are unwilling to employ adequate contraception

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

No Placebo-Only Group

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.

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.

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 below

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My kidney cancer is not the common 'clear cell' type.

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I have had one treatment for my cancer that has spread, but it wasn't with pazopanib.

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I can take care of myself and am up and about more than half of my waking hours.

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My cancer has spread, and it can be measured or seen on tests.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have stomach or intestine problems that could cause bleeding.

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I am of childbearing age and do not plan to use birth control.

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I do not have any severe illnesses besides my current condition.

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I am currently breastfeeding.

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I am immunocompromised due to conditions other than corticosteroid use, including HIV.

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I have not had any other cancer within the last 5 years.

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I have been treated with pazopanib before.

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My cancer has spread to my brain or spinal cord.

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I have stomach or intestine problems that could affect how I absorb medication.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Overall Survival Rate at 12 Months

Secondary study objectives

Number of Participants Experiencing at Least One Toxicity

Number of Participants With Best Response in the First 2 Cycles

Overall Survival

+1 more

Side effects data

From 2016 Phase 2 trial • 22 Patients • NCT01247571

79%

Nausea

74%

Fatigue

68%

Diarrhea

53%

Neutrophil Count Decreased

53%

Hypertension

53%

White Blood Cell Decreased

47%

Anemia

42%

Vomiting

42%

Peripheral Sensory Neuropathy

37%

Abdominal Pain

37%

Constipation

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%

Blood Bilirubin Increased

16%

Blurred Vision

16%

Dysphagia

16%

Dry Mouth

16%

Alkaline Phosphatase Increased

16%

Hypomagnesemia

16%

Hypocalcemia

16%

Arthralgia

16%

Memory Impairment

16%

Insomnia

16%

Epistaxis

11%

Rectal Hemorrhage

11%

Gastroesophageal Reflux Disease

11%

Tinnitus

11%

Hearing Impaired

11%

Platelet Count Decreased

11%

Creatinine Increased

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

Proctitis

Ascites

Edema Limbs

Mucositis Oral

Pain

Oral Pain

Edema Trunk

Flatulence

Fever

Gastrointestinal Pain

Bloating

Sinusitis

Death Nos

Reproductive System And Breast Disorders - Other

Sinus Bradycardia

Sinus Tachycardia

Ear Pain

Dyspepsia

Sepsis

Urinary Tract Infection

Bruising

Investigations - Other

Lymphocyte Count Decreased

Dehydration

Back Pain

Arthritis

Paresthesia

Dysgeusia

Urinary Retention

Pelvic Pain

Allergic Rhinitis

Skin And Subcutaneous Tissue Disorders - Other

Nail Discoloration

Dry Skin

Proteinuria

100%

80%

60%

40%

20%

Study treatment Arm

Pazopanib

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 13Eligibility criteria met