A Phase I Study of NX211 Given as an IV Infusion Days 1, 2 and 3 Every 3 Weeks in Patients With Solid Tumors
OBJECTIVES: I. Determine the maximum tolerated dose (MTD) and the future dose of lurtotecan
liposome in patients with advanced solid tumors. II. Assess the toxicity and
pharmacokinetics of this treatment regimen in this patient population. III. Assess the
response to this regimen by patients with measurable disease.
OUTLINE: This is a dose escalation, multicenter study. Patients receive lurtotecan liposome
(NX211) IV over 30 minutes on days 1, 2, and 3. Courses are repeated every 3 weeks.
Treatment continues for up to 6 courses in the absence of unacceptable toxicity or disease
progression. The dose of NX211 is escalated in cohorts of 3-6 patients until the maximum
tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2
of 6 patients experience dose limiting toxicity. Patients are followed at 4 weeks and every
3 months for 1 year.
PROJECTED ACCRUAL: A total of 20-25 patients will be accrued for this study within 12-15
Primary Purpose: Treatment
Karen A. Gelmon, MD
British Columbia Cancer Agency
United States: Federal Government