Protocol Number: 09-C-0003

Title:

A Phase I and Pharmacokinetic Single Agent Study of Pazopanib in Adults with Advanced Malignancies and Varying Degrees of Liver Dysfunction

Number:

09-C-0003

Summary:

Background:

- Pazopanib is an experimental drug that was designed to enter cancer cells and block the activity of proteins that are important for cancer cell growth and survival.

- This is the first study in which pazopanib is given to patients with different degrees of liver function. The safe dose for patients with normal liver function is already known.

Objectives:

- To determine the safety and side effects of pazopanib given at different dose levels to patients with cancer who have different degrees of liver function.

- To find out how much pazopanib is in the blood at specific times.

- To determine if pazopanib is effective in treating advanced cancer in patients with different degrees of liver function.

Eligibility:

- Patients 18 years of age and older with an advanced solid tumor or lymphoma that cannot be treated successfully with standard therapies and who have normal or abnormal liver function.

Design:

- Treatment:

- Patients are divided into 4 groups, based on their liver function. The first three patients in each group receive a low dose of pazopanib. The next three in each group receive a higher dose of pazopanib if no serious side effects were reported in the previous three. The dose is increased in succeeding groups of three patients until the maximum study dose is reached.

- Patients take pazopanib once a day by mouth in 21-day treatment cycles. Treatment continues until the cancer worsens, the patient develops severe side effects, the patient no longer wants to continue the study, or the doctor removes the patient from the study for other reasons.

- Monitoring:

- Blood pressure: Patients monitor and record their blood pressure twice a day after starting treatment.

- Blood tests: Patients have weekly routine blood tests. In addition, at week 3 of the first cycle and again after the highest safe dose has been determined, several blood samples are collected at frequent intervals to determine how the body handles the drug.

- Imaging studies: X-rays or scans or both are done to measure the extent of disease every 3 cycles.

- Physical examinations are done at periodic intervals.

Sponsoring Institute:

National Cancer Institute (NCI)

Recruitment Detail

Type: Participants currently recruited/enrolled

Gender: Male & Female

Referral Letter Required: No

Population Exclusion(s): Children

Eligibility Criteria:

INCLUSION CRITERIA:

For patients at the NCI, histological or cytological confirmation of solid tumor or lymphoma diagnosis will be performed at the NCI Laboratory of Pathology.

EXCLUSION CRITERIA:

Patients who have had prior treatment with pazopanib will not be eligible for this study.

Patients with abnormal liver function except grade 4 AST, grade 4 ALT, and grade 4 bilirubin will be eligible and will be grouped according to the criteria in Section 5.1. For assessing hepatic dysfunction, greater than 35 percent of the total bilirubin must be direct bilirubin.

Special Instructions:

Currently Not Provided

Keywords:

Pazopanib

Tyrosine Kinase Inhibitor

Advanced Cancer

Pharmacokinetics

Recruitment Keyword(s):

Cancer

Solid Tumor

Lymphoma

Condition(s):

Neoplasms

Lymphoma

Investigational Drug(s):

Pazopanib (GW786034)(GW786034)

Investigational Device(s):

None

Intervention(s):

Drug: Pazopanib

Drug: Pazopanib (GW786034)(GW786034)

Supporting Site:

National Cancer Institute

Contact(s):

NCI Referral Office
National Institute of Health Clinical Center (CC), 9000 Rockville Pike, Bethesda, Maryland 20892, United States: NCI Clinical Trials Referral Office
Phone: 1-888-NCI-1937
Fax: Not Listed
Electronic Address: ncicssc@mail.nih.gov

Citation(s):

Cheson BD, Pfistner B, Juweid ME, Gascoyne RD, Specht L, Horning SJ, Coiffier B, Fisher RI, Hagenbeek A, Zucca E, Rosen ST, Stroobants S, Lister TA, Hoppe RT, Dreyling M, Tobinai K, Vose JM, Connors JM, Federico M, Diehl V; The International Harmonization Project on Lymphoma. Revised response criteria for malignant lymphoma. J Clin Oncol. 2007 Feb 10;25(5):579-86. Epub 2007 Jan 22.

Conn HO. A peek at the Child-Turcotte classification. Hepatology. 1981 Nov-Dec;1(6):673-6.

Conn HO, Resnick RH, Grace ND, Atterbury CE, Horst D, Groszmann RJ, Gazmuri P, Gusberg RJ, Thayer B, Berk D, Wright SC, Vollman R, Tilson DM, McDermott WV, Cohen JA, Kerstein M, Toole AL, Maselli JP, Razvi S, Ishihara A, Stern H, Trey C, O'Hara ET, Widrich W, Aisenberg H, Stansel HC, Zinny M. Distal splenorenal shunt vs. portal-systemic shunt: current status of a controlled trial. Hepatology. 1981 Mar-Apr;1(2):151-60.

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