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Brief Title: Phase I, Multicenter, Open-label, Dose-escalating, Clinical and Pharmacokinetic Study of PM01183 in Patients With Advanced Solid Tumors
Official Title: Phase I, Multicenter, Open-label, Dose-escalating, Clinical and Pharmacokinetic Study of PM01183 in Patients With Advanced Solid Tumors
Study ID: NCT00877474
Brief Summary: This is a phase I, multicenter, open-label, dose escalating clinical and pharmacokinetic study of PM01183 for patients with advanced solid tumors
Detailed Description: This is a phase I, multicenter, open-label, dose escalating clinical and pharmacokinetic study of PM01183 for patients with advanced solid tumors to identify the dose limiting toxicities (DLTs), determine the maximum tolerated dose (MTD) and the recommended dose (RD) of PM01183 administered every three weeks intravenously (i.v.) over one hour to patients with advanced solid tumors and to preliminarily determine the pharmacokinetics of PM01183, to evaluate the antitumor activity of PM01183 and the safety and tolerability of PM01183. Besides this study will evaluate the pharmacogenomics in tumor samples and peripheral white blood cells (PWBCs) of patients exposed to PM01183 at the RD in order to assess potential markers of response and/or resistance.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Cancer Research Center. University of Chicago Hospitals., Chicago,, Illinois, United States
Vall d'Hebron University Hospital., Barcelona, , Spain
Name: Mark Ratain, MD
Affiliation: Cancer Research Center. University of Chicago Hospitals.
Role: PRINCIPAL_INVESTIGATOR
Name: Josep Tabernero, MD
Affiliation: Vall d'Hebron University Hospital. Barcelona (Spain)
Role: PRINCIPAL_INVESTIGATOR