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Details for trial 0C-07-9

Description:	A Phase I and Pharmacokinetic Single Agent Study of Pazopanib in Patients with Advanced Malignancies and Varying Degrees of Liver Dysfunction.
Status:	Open
Randomized?	No

Researchers

Principal Investigator	Title
Heinz Josef Lenz	M.D.

Data Management

Name	Title
Claire Hughlett	R.N.
Lynette Sebastian	D.M.
Anayansi Miloud	D.M.
Xiomara Menendez	R.N.

You may participate in this study if:

	Requirement
1	Histologically or cytologically confirmed metastatic or unresectable solid tumor or lymphoma & for which standard curative or palliative treatment do not exist or are no longer effective.
2	Patients with a liver mass, raised aFP (500 ng/mL or higher) & positive serology for hepatitis consistent with hepatocellular cancer will be eligible without need for pathologic confirmation of diagnosis.
3	18 y/o and above.
4	Life expectancy >3 mos.
5	KPS 60% and above.
6	Labs within 7 days of treatment: ANC 1500 or greater; Platelets 100,000 or greater; Creatinine within normal or Creatinine Clearance 60 mL/min or greater if creatinine > upper limit of normal.
7	Patients with abnormal liver function will be eligible & will be grouped according to hepatic function criteria. Patients with active hemolysis should be excluded. No distinction will be made on cause of liver dysfunction, whether due to metastases or other causes. Liver function tests should be repeated within 24 hrs prior to initial treatment.
8	Patients with gliomas or brain metastases who require corticosteroids (CTS) or anticonvulsants must be on stable dose of CTS & seizure-free x 1 month prior to enrollment. Patients with known brain metastases should have had brain irradiation (whole brain or gamma knife) > 4 wks before treatment. Steroids should be tapered to low dose (i.e. < 1.5 mg of dexamethasone/day).
9	Patients with history of venous thromboembolism requiring anticoagulation must be asymptomatic & stabilized on LMWH. Full dose warfarin is not allowed.
10	Patients with biliary obstruction with a shunt are eligible, provided shunt has been in place for at least 10 days prior to treatment & liver function has stabilized. 2 measurements at least 2 days apart that put ptaient in same hepatic dysfunction stratum will be accepted as evidence of stable hepatic function. There should be no biliary sepsis.
11	Eligibility of patients taking any drug known to affect or with potential to affect activity or PK of pazopanib will be determined after investigators review. Patients with gliomas or brain metastases taking anticonvulsants which impact CYP450 function should be switched to other medications.
12	Men & women of reproductive potential must agree to use adequate contraception prior to study, while on study & for 3 mos after last dose. A double barrier method should be used. Male partners of patients on study should also use barrier contraception. Hormonal contraceptives not allowed due to possible interactions with pazopanib.
13	Signed Informed Consent, including HIPAA authorization.

You may not participate in this study if:

1	Chemotherapy, targeted therapy, or biotherapy within 3 wks. Radiotherapy within 4 wks. Nitrosoureas or mitomycin C within 6 wks.
2	Not recovered from toxicities due to agents received > 4 wks earlier. Patients treated with agents that persist in the body longer than 4-6 wks (such as suramin & bevacizumab) are ineligible during the elimination period for those agents.
3	Major surgery within 28 days.
4	Prior treatment with pazopanib (if otherwise eligible, discuss this issue with PI).
5	Receiving any other investigational agents.
6	Unstable or untreated (non-irradiated) brain metastases.
7	History of allergic reactions to sulfonamides, microcrystalline cellulose, povidone, sodium starch glycolate, magnesium stearate, titanium dioxide (E171), hypromellose (E464), polyethylene glycol 400 (also known as macrogol 400), or polysorbate 80 (E433).
8	Taking prohibited medications. (see protocol appendix C).
9	Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic heart failure, unstable angina, cardiac arrhythmia or psychiatric illness/social situations that would limit study compliance. Must have systolic BP <140 & diastolic BP < 90; may be achieved with medication; note precautions with calcium channel blockers.
10	Urine protein must be 1+ or less (or 24-hr urine protein must be < 3 grams).
11	Pregnant women.
12	HIV positive, on combination antiretroviral tx. HIV positive patients without an AIDS-defining diagnosis & not receiving agents with potential for PK interactions with pazopanib may be eligible.
13	If specific cause of hepatic dysfunction unknown, patient should be worked up for other viral causes of hepatitis; their eligibility determined after consultation with PI.

For further information on, or to sign up for this study, please contact the Clinical Investigation Support Office at (323) 865-0451 or the Principal Investigator noted above.