Spots Global Cancer Trial Database for A Dose-escalation Pharmacokinetic Study of Intravenous ASA404 in Adult Advanced Cancer Patients With Impaired Renal Function and Patients With Normal Renal Function
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Trial Identification
Brief Title: A Dose-escalation Pharmacokinetic Study of Intravenous ASA404 in Adult Advanced Cancer Patients With Impaired Renal Function and Patients With Normal Renal Function
Official Title: A Multi-center, Open-label, Dose-escalation Study to Assess the Pharmacokinetics of Intravenous ASA404 in Adult Advanced Cancer Patients With Impaired Renal Function and With Normal Renal Function
Study ID: NCT01278758
Conditions
Interventions
Study Description
Brief Summary: 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.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
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
Contact Details
Name: Novartis Pharmaceuticals
Affiliation: Novartis Investigative Site
Role: STUDY_DIRECTOR
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