A Phase 1/Pharmacokinetic Study of Sunitinib in Patients With Cancer Who Also Have HIV and Are on HAART Therapy
I. To determine the safety and to investigate the pharmacological interactions of
administering sunitinib (sunitinib malate) in subjects with cancer who are also HIV positive
on anti-retroviral regimens containing protease inhibitors and/or non-nucleoside reverse
I. To evaluate the efficacy of sunitinib in treating non-acquired immunodeficiency syndrome
(AIDS) defining cancers (NADCs) in these subjects.
II. To detect alterations in antiretroviral drug pharmacokinetics due to sunitinib.
III. To detect alterations in immune parameters, including total leukocyte count, cluster of
differentiation (CD) 4 and viral load, during sunitinib therapy.
IV. To correlate variations in genes involved in sunitinib absorption, metabolism, and
elimination, including cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4),
cytochrome P450, family 3, subfamily A, polypeptide 5 (CYP3A5), ATP-binding cassette,
sub-family B (MDR/TAP), member 1 (ABCB1), and breast cancer resistance protein (ABCG2), with
V. To explore the potential for pharmacological interactions between sunitinib and newer
antiretroviral agents such as integrase and chemokine (C-C motif) receptor 5
(gene/pseudogene) (CCR5) inhibitors.
OUTLINE: This is a dose-escalation study.
Patients receive sunitinib malate orally (PO) daily on days 1-28. Courses repeat every 6
weeks in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for 30 days.
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Grades 3, 4, and 5, treatment-related adverse events, graded according to the National Cancer Institute (NCI) CTCAE version 3.0
Results will be presented descriptively. Continuous data will be summarized for each cohort using descriptive statistics (N, mean, median, standard deviation, minimum, maximum, geometric mean, and % coefficient of variation [CV]).
Up to 30 days after completion of study treatment
AIDS Associated Malignancies Clinical Trials Consortium
United States: Food and Drug Administration
|Albert Einstein College of Medicine||Bronx, New York 10461|
|Memorial Sloan Kettering Cancer Center||New York, New York 10021|
|Beth Israel Deaconess Medical Center||Boston, Massachusetts 02215|
|Abramson Cancer Center of the University of Pennsylvania||Philadelphia, Pennsylvania 19104-4283|
|Virginia Mason Medical Center||Seattle, Washington 98111|
|Northwestern University||Chicago, Illinois 60611|
|Case Western Reserve University||Cleveland, Ohio 44106|
|Lombardi Comprehensive Cancer Center at Georgetown University||Washington, District of Columbia 20057|
|Jonsson Comprehensive Cancer Center||Los Angeles, California 90095|
|AIDS - Associated Malignancies Clinical Trials Consortium||Rockville, Maryland 20850|
|Washington University - Jewish||Saint Loius, Missouri 63110|