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Tyrosine Kinase Inhibitor

Pazopanib for Advanced or Refractory Cancer

Jacksonville, FL

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

Must not have

Subjects with any of the following cardiovascular conditions within the past 6 months: Cerebrovascular accident (CVA) or transient ischemic attack (TIA), Admission for unstable angina, Myocardial infarction, Cardiac angioplasty or stenting, Coronary artery bypass graft surgery, Pulmonary embolism, untreated deep venous thrombosis (DVT) or DVT which has been treated with therapeutic anticoagulation for less than 6 weeks, Arterial thrombosis, Symptomatic peripheral vascular disease, Class III or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system; a subject who has a history of class II heart failure and is asymptomatic on treatment may be considered eligible, Active cardiac arrhythmia (except sinus arrhythmia, atrial fibrillation, asymptomatic premature ventricular contractions [PVCs]), Ejection fraction < institutional lower limit of normal (LLN) and/or history of cardiomyopathy, Receiving a medication with known risk of torsades de pointes; the following medications are specifically prohibited: amiodarone, arsenic trioxide, bepridil, chloroquine, chlorpromazine, cisapride, clarithromycin, disopyramide, dofetilide, dolasetron, droperidol, erythromycin, halofantrine, haloperidol, ibutilide levomethadyl, mesoridazine, methadone, pentamidine, pimozide, procainamide, quinidine, sotalol, sparfloxacin, and thioridazine; patients should be watched carefully for indications of torsades de pointes, such as syncope; performing additional electrocardiograms (EKGs) on subjects who must take one or more of these medications is not required; however, additional investigations, including EKGs, may be performed as per the treating physician's judgment, Blood pressure (BP) > 140 mmHg (systolic) and > 90 mmHg (diastolic); initiation or adjustment of BP medication is permitted prior to registration provided that the average of three BP readings at a visit prior to registration is < 140/90 mmHg

Any of the following prior therapies: Chemotherapy =< 28 days prior to registration, Mitomycin C/nitrosoureas =< 42 days prior to registration, Immunotherapy =< 28 days prior to registration, Biologic therapy =< 28 days prior to registration, Radiation therapy =< 28 days prior to registration, Radiation to > 25% of bone marrow, Failure to fully recover from acute, reversible effects of prior chemotherapy (other anti-neoplastic therapy) and radiation therapy, Subjects with known brain metastases

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 months

Awards & highlights

No Placebo-Only Group

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.

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.

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 below

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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.

Exclusion Criteria

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

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I don't have stomach ulcers, bowel diseases, or recent severe stomach/intestine issues.

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My heart's electrical cycle is longer than normal or I'm on medication that can extend it.

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I do not have any serious illnesses or social situations that would stop me from following the study's requirements.

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There is a known treatment that could cure or extend my life.

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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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 months

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

Treatment Details

Study Objectives

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

Primary study objectives

Adverse events profile, as assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0

Incidence of grade 3+ adverse events, as assessed by the NCI CTCAE version 4.0

Response profile, assessed using modified Response Evaluation Criteria in Solid Tumors (RECIST)

+1 more

Secondary study objectives

Pazopanib hydrochloride levels attained in response to standard dosing

Steady state pazopanib hydrochloride trough levels

Trough pazopanib hydrochloride levels

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 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

~860

0 / 16Eligibility criteria met