Pazopanib Hydrochloride in Treating Patients With Advanced or Refractory Solid Tumors

Running, not enrolling · Phase 1

Conditions studied: Solid Neoplasm

In brief

This phase I trial studies the side effects and the best dose of pazopanib hydrochloride in treating patients with solid tumors that has spread to other places in the body and usually cannot be cured or controlled with treatment (advanced) or does not respond to treatment (refractory). Pazopanib hydrochloride may prevent the growth of new blood vessels that tumors need to grow. Studying samples of blood in the laboratory from patients receiving pazopanib hydrochloride may help doctors learn more about the effects of the body on the drug. It may also help doctors understand how well patients respond to treatment.

Key facts

Study ID: NCT01552356
Run by: National Cancer Institute (NCI)
People needed: 54
Starts: 2012-03-19
Expected to finish: 2027-03-31
Last updated by the study team: 2026-04-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Histologic proof of cancer which is now not amenable to alternative curative or clearly superior standard treatment options
Measurable disease
Hemoglobin (Hgb) >= 8.0 g/dL
Absolute neutrophil count (ANC) >= 1,500/uL
Platelet (PLT) = 100,000/uL
Activated partial thromboplastin time (APTT) < 1.2 times upper limit of normal (ULN); (Note: use of warfarin is prohibited; low molecular weight heparin is allowed, so long as these criteria are met)
International normalized ratio (INR) < 1.2 times ULN; (Note: use of warfarin is prohibited; low molecular weight heparin is allowed, so long as these criteria are met)
Direct bilirubin =< 1.5 X upper limit of normal (ULN) (subjects with Gilbert's syndrome and elevations of indirect bilirubin only are eligible)
Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) =< 2.5 X ULN
Creatinine =< 1.5 times ULN OR measured creatinine clearance of >= 60 mL/min 1.73 m\^2
Urine protein/creatinine ratio < 1 or 24-hour urine < 1 gram
< Grade 2 hypo/hyperkalemia
< Grade 3 hypo/hypercalcemia
< Grade 3 hypo/hyperphosphatemia
< Grade 3 hypo/hypermagnesemia
Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1
Ability to provide informed consent
Willing to return to Mayo Clinic for follow up
Life expectancy >= 84 days (3 months)
Willingness to provide mandatory blood samples for pazopanib drug level assessments required for dosage adjustments, as well as for required pharmacogenomic studies
Women of childbearing potential only: negative serum pregnancy test done =< 14 days prior to registration

You may not qualify if…

Known standard therapy for the patient's disease that is potentially curative or definitely capable of extending life expectancy
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
Corrected QT interval (QTc) >= 480 msec and/or receiving any concomitant medications that are associated with a risk of QTc prolongation and/or torsades de pointes; NOTE: these medications should be discontinued or replaced with drugs that do not carry these risks
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

Where it is running

Mayo Clinic in Florida — Jacksonville, Florida, United States
Mayo Clinic in Rochester — Rochester, Minnesota, United States

Full record on ClinicalTrials.gov

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