The purpose of this study is to evaluate the safety and pharmacokinetics of ASA404 in patients with refractory or relapsed metastatic cancer with impaired renal function and with normal renal function. It is very possible that patients with renal impairment will show differences in renal excretion of parent ASA404 and its metabolites, warranting a study that leads to a better pharmacokinetic assesssment in this population.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
7
Indiana University Melvin and Bren Simon Cancer Center, Hematology/Oncology Dept.
Indianapolis, Indiana, United States
Hematology /Oncology Associates
Rockville, Maryland, United States
Joseph Ford Cancer Center/Clinical Trials Office, Henry Ford Health System
Detroit, Michigan, United States
Seattle Cancer Care Alliance
Seattle, Washington, United States
To evaluate the pK of a single intravenous dose of ASA404 1200 and 1800 mg/m2 monotherapy in adult cancer patients with impaired renal function compared to matching patients with normal renal function
Time frame: 12 months
To evaluate the pharmacokinetics of a single i.v. dose of ASA 1200 and 1800 mg/m2 +chemotherapy (doctaxel or paclitaxel + carboplatin) in adult cancer patients with impaired renal function compared to matching patients with normal renal function
Time frame: 12 months
To assess the safety and tolerability of ASA404 in adult cancer patients with impaired renal function compared to matching patients with normal renal function
Time frame: 12 months
To assess the safety and tolerability of ASA404 1200 or 1800 mg/m2 in combination with chemotherapy (docetaxel or paclitaxel + carboplatin)
To evaluate ASA404 pharmacokinetic parameters including AUC (0-t last),), AUC (0-inf)), T ((½)), CL, V(Z), Cmax, and Tmax
To evaluate renal clearance (CLR) of ASA404.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.