NCT00004030

VX-853 in Treating Patients With Solid Tumors Who Are Receiving Liposomal Doxorubicin

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 45 (estimated)
• Sponsor: Georgetown University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase I/II trial to study the effectiveness of VX-853 in treating patients who have solid tumors who are receiving liposomal doxorubicin.

Detailed description

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 patients. 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.

Conditions

• Unspecified Adult Solid Tumor, Protocol Specific

Interventions

Type	Name	Description
DRUG	VX-853
DRUG	pegylated liposomal doxorubicin hydrochloride

Timeline

• Start date: 1996-03-01
• Primary completion: 2001-01-01
• Completion: 2001-01-01
• First posted: 2004-05-25
• Last updated: 2011-03-24

Locations

1 site across 1 country: United States