A Phase I/II Study of the Pharmacokinetics, Tolerability and Safety of Administration of VX-853 to Patients Receiving Single Agent Therapy With Doxorubicin HCI
OBJECTIVES: I. Determine the safety and tolerability of VX-853 in combination with
doxorubicin HCl liposome in patients with relapsed or incurable solid tumors. II. Obtain
pharmacokinetic profiles for various dosages of VX-853 administered in combination with
doxorubicin HCl liposome. III. Achieve whole blood concentrations of VX-853 in the predicted
therapeutically effective range and characterize the pharmacokinetics at these doses. IV.
Document antitumor effects of VX-853 in combination with doxorubicin HCl liposome in these
OUTLINE: This is a dose escalation study of VX-853. Patients receive VX-853 orally every 8
hours on days 1-3 and doxorubicin HCL liposome IV over approximately 15 minutes beginning 26
hours after starting VX-853. Treatment repeats every 3 weeks in the absence of disease
progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of
VX-853 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose
preceding that at which 2 or more of 6 patients experience dose limiting toxicity.
PROJECTED ACCRUAL: A maximum of 45 patients will be accrued for this study within
approximately 18 months.
Primary Purpose: Treatment
Michael J. Hawkins, MD
Lombardi Cancer Research Center
United States: Federal Government
|Vincent T. Lombardi Cancer Research Center, Georgetown University||Washington, District of Columbia 20007|