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Tyrosine Kinase Inhibitor
Pazopanib for Advanced or Refractory Cancer
Phase 1
Waitlist Available
Led By Keith C Bible
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Histologic proof of cancer which is now not amenable to alternative curative or clearly superior standard treatment options
< Grade 2 hypo/hyperkalemia
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 months
Awards & highlights
Study Summary
This trial is studying the side effects and best dose of pazopanib hydrochloride for treating patients with solid tumors that have spread or are resistant to treatment. Samples of blood from patients will be studied to learn more about how the drug affects the body and how well patients respond to treatment.
Who is the study for?
This trial is for patients with advanced or treatment-resistant solid tumors. Eligible participants must have normal organ function, measurable disease, no severe heart conditions or blood clots in the past 6 months, and a life expectancy of at least 3 months. They should not be pregnant or nursing and must agree to use contraception.Check my eligibility
What is being tested?
The study is testing Pazopanib Hydrochloride's effectiveness on preventing tumor growth by inhibiting new blood vessel formation. It involves determining the best dose while monitoring side effects and how the body processes the drug through blood sample analysis.See study design
What are the potential side effects?
Potential side effects include high blood pressure, liver issues reflected in altered lab tests, fatigue, diarrhea, nausea, changes in hair color, hypertension and possible risks to heart health such as irregular heartbeat.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer cannot be treated with surgery or other standard treatments.
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My potassium levels are mostly stable.
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My cancer cannot be cured by standard treatments.
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My calcium levels are mostly normal.
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My cancer can be measured by tests or scans.
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I am fully active or have some restrictions but can still care for myself.
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My kidney function, measured by creatinine levels or clearance, is within the required range.
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My magnesium levels are not severely low or high.
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My blood phosphate levels are mostly normal.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Adverse events profile, as assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Biologically optimal dose (BOD) defined as the dose level and diet in combination that induces no toxicity requiring dose modification per protocol and achieves a satisfactory pazopanib trough concentration (Cmin greater than 30 ug/mL)
Incidence of grade 3+ adverse events, as assessed by the NCI CTCAE version 4.0
+7 moreSecondary outcome measures
Pazopanib hydrochloride levels attained in response to standard dosing
Steady state pazopanib hydrochloride trough levels
Trough pazopanib hydrochloride levels
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (pazopanib hydrochloride)Experimental Treatment3 Interventions
Patients receive pazopanib hydrochloride PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Course length can be extended to 56 days at the discretion of the treating physician after 12 courses (1 year) of treatment on study.
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)Lead Sponsor
13,717 Previous Clinical Trials
40,953,309 Total Patients Enrolled
3 Trials studying Tumors
1,244 Patients Enrolled for Tumors
Keith C BiblePrincipal InvestigatorMayo Clinic
2 Previous Clinical Trials
174 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I don't have stomach ulcers, bowel diseases, or recent severe stomach/intestine issues.You are currently experiencing a serious wound, ulcer, bone fracture, or bleeding disorder. You have a history of abnormal bleeding or hemoptysis (coughing up blood) within the past 8 weeks. You have poorly controlled depression or anxiety, or have had suicidal thoughts within the past 6 months. You are taking warfarin, but not low molecular weight heparin. You are HIV-positive and receiving combination antiretroviral therapy.My heart's electrical cycle is longer than normal or I'm on medication that can extend it.My blood clotting time is near normal and I'm not on warfarin.I can swallow and absorb pills without any issues.My blood clotting time is within normal limits and I'm not on warfarin.My cancer cannot be treated with surgery or other standard treatments.I do not have any serious illnesses or social situations that would stop me from following the study's requirements.Your platelet count is at least 100,000 per microliter.My potassium levels are mostly stable.My cancer cannot be cured by standard treatments.There is a known treatment that could cure or extend my life.I agree to give blood samples for drug level checks and genetic studies.My calcium levels are mostly normal.You are expected to live for at least 3 more months.My cancer can be measured by tests or scans.I am fully active or have some restrictions but can still care for myself.Your AST (a liver enzyme) level is not more than 2.5 times the upper limit of normal (ULN).You cannot participate in the study if you are pregnant, breastfeeding, or not willing to use contraception. You also cannot be receiving other chemotherapy, radiation therapy, or experimental treatments. If you have any severe illnesses or diseases that could interfere with the study, you cannot participate. If you have a weakened immune system, are taking certain medications, or have had certain types of cancer in the past, you may not be eligible. Additionally, if you have been taking mitotane in the last 6 months, you cannot participate.Your direct bilirubin levels are not more than 1.5 times the normal limit. If you have Gilbert's syndrome and high indirect bilirubin levels, you can still participate.My kidney function, measured by creatinine levels or clearance, is within the required range.My magnesium levels are not severely low or high.Your hemoglobin levels must be at least 8.0 g/dL.Your ANC (a type of white blood cell) count must be at least 1,500 cells per microliter.My blood phosphate levels are mostly normal.
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.
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