Effect on QTc, Pharmacokinetics, Safety, and Preliminary Efficacy of Single-agent Palifosfamide-tris in Subjects With Advanced Solid Tumors
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|ClinicalTrials.gov Identifier: NCT01340547|
Recruitment Status : Unknown
Verified July 2013 by Ziopharm.
Recruitment status was: Active, not recruiting
First Posted : April 22, 2011
Last Update Posted : July 18, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Advanced Solid Tumors||Drug: palifosfamide-tris Drug: Normal Saline||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||24 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||June 2011|
|Estimated Primary Completion Date :||September 2013|
|Estimated Study Completion Date :||September 2013|
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)
Drug: Normal Saline
0.9% Normal Saline 250 ml IV infusion on Cycle 1 Day -1
- ECG QTc intervals of patients who receive palifosfamide-tris [ Time Frame: Cycle 1 Days -1,1, 2, 3,8 ]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 ]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 ]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 ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01340547
|United States, Texas|
|Dallas, Texas, United States, 75230|
|Houston, Texas, United States, 77030|
|San Antonio, Texas, United States, 78229|