Phase I Study of Dalteparin, A Low Molecular Weight Heparin (LMWH), in Combination With Sunitinib (SU11248), an Oral, Selective Multi-targeted Tyrosine Kinase Inhibitor, as First Line Treatment, in Patients With Metastatic Renal Cell Carcinoma
PRIMARY OBJECTIVES:
I. To determine the recommended dosing for the combination of sunitinib (sunitinib malate)
and dalteparin in patients with metastatic renal cell carcinoma.
II. To evaluate safety and tolerability for the combination of sunitinib and dalteparin in
patients with metastatic renal cell carcinoma.
III. To determine early signs of clinical activity of the combination of sunitinib and
dalteparin in patients with metastatic renal cell carcinoma.
SECONDARY OBJECTIVES:
I. To determine the clinical response rate of sunitinib and dalteparin in patients with
metastatic renal cell carcinoma.
II. To determine time-to-progression (TTP) and overall survival amongst patients with
metastatic renal cell carcinoma receiving sunitinib and dalteparin.
III. To determine the effect of sunitinib alone and dalteparin alone compared to the
combination of dalteparin plus sunitinib on plasma coagulation parameters.
IV. To determine the effect of sunitinib alone and dalteparin alone compared to the
combination of dalteparin plus sunitinib on angiogenesis parameters in blood.
OUTLINE: This is a dose-escalation study of dalteparin.
Patients receive sunitinib malate orally (PO) once daily in weeks 1-4 and dalteparin
subcutaneously (SC) once daily in week 6 during course 1. In all subsequent courses,
patients receive sunitinib malate PO once daily in weeks 1-4 and dalteparin SC once daily in
weeks 1-6. Courses repeat every 6 weeks in the absence of disease progression or
unacceptable toxicity.
After completion of study treatment, patients are followed up at 4 weeks and then every 3
months for 3 years.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Recommended dosing for the combination of dalteparin and sunitinib malate
The maximally tolerated dose (MTD) will be the highest dose at which < 33% of patients (=< 2 out of 6 patients) suffer from dose limiting toxicities (DLTs) related to the combination treatment.
Within the first 4 weeks of combination therapy
Yes
Roberto Pili
Principal Investigator
Roswell Park Cancer Institute
United States: Food and Drug Administration
I 145508
NCT01061411
February 2010
Name | Location |
---|---|
Roswell Park Cancer Institute | Buffalo, New York 14263 |
City of Hope | Duarte, California 91010 |
Johns Hopkins University CCOP | Baltimore, Maryland 21287 |