Effect on QTc, Pharmacokinetics, Safety, and Preliminary Efficacy of Single-agent Palifosfamide-tris in Subjects With Advanced Solid Tumors
This is an open-label study of palifosfamide-tris administered intravenously on Days 1, 2, and 3 of a 21-day cycle to subjects with advanced solid tumors. Enrolled subjects will receive a placebo-control infusion on Day -1 and then commence palifosfamide-tris study treatment 24 hours later on Day 1.
Time-matched, intensive ECG monitoring will occur during and following placebo and palifosfamide-tris infusions on Days -1, 1, 2, 3 and 8. Generation of ECG data for study analysis will be performed in a blinded fashion at a central ECG laboratory.
Blood and urine sampling to characterize the pharmacokinetics of palifosfamide-tris will be performed on Days 1 through 8 of Cycle 1.
Advanced Solid Tumors
Drug: Normal Saline
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I Multicenter, Open-label Study of the Effect on QTc, Pharmacokinetics, Safety, and Preliminary Efficacy of Single-agent Palifosfamide-tris in Subjects With Advanced Solid Tumors|
- ECG QTc intervals of patients who receive palifosfamide-tris [ Time Frame: Cycle 1 Days -1,1, 2, 3,8 ] [ Designated as safety issue: Yes ]To assess the effect of single-agent palifosfamide-tris on QTc intervals.
- Blood sampling to characterize the pharmacokinetics of palifosfamide-tris [ Time Frame: Cycle 1, Day 1, 2, 3, 4, 8 ] [ Designated as safety issue: Yes ]To assess the pharmacokinetic profile of single-agent palifosfamide-tris.
- Safety and tolerability of palifosfamide-tris measured in amount, type, severity and relatedness of Adverse Events [ Time Frame: Duration of time patient is on study, expected average of 5 months ] [ Designated as safety issue: Yes ]To assess the safety and tolerability of single-agent palifosfamide-tris.
- Preliminary efficacy of palifosfamide-tris as it pertains to cancer tumor growth [ Time Frame: Duration of time patient is on study, expected average of 5 months ] [ Designated as safety issue: No ]To obtain preliminary efficacy data as defined by objective response rate (ORR); progression-free survival (PFS); and durability of response in subjects with advanced solid tumors when treated with single-agent palifosfamide-tris.
|Study Start Date:||June 2011|
|Estimated Study Completion Date:||September 2013|
|Estimated Primary Completion Date:||September 2013 (Final data collection date for primary outcome measure)|
Single Arm, non-blinded, non-randomized
palifosfamide-tris IV infusion of 150 mg/m2 on Days 1, 2 and 3 every three weeks (21 day cycle)
Other Names:Drug: Normal Saline
0.9% Normal Saline 250 ml IV infusion on Cycle 1 Day -1