Phase I Multicenter, Open-label, Clinical and Pharmacokinetic Study of PM01183 on Days 1 and 8 Every Three Weeks (q3wk) in Non-Colorectal Cancer (Non-CRC) Patients
Phase I Study of PM01183 in Non-Colorectal (non-CRC) Cancer Patients to determine the
recommended dose (RD) of PM01183, to characterize the safety profile, compliance and
feasibility of the schedule, to optimize and individualize PM01183 dosing in non-CRC
patients according to individual tolerance, to characterize the pharmacokinetics (PK) of the
schedule, to obtain preliminary information on the clinical antitumor activity and to
perform an exploratory pharmacogenomics (PGx) analysis.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Recommended dose (RD)
To determine the recommended dose (RD) of PM01183 administered as a 1-hour infusion intravenously (i.v.) on Days 1 and 8 every three weeks (q3wk) in non-colorectal cancer (non-CRC) patients.
From treatment onset to end of treatment
United States: Food and Drug Administration
|University of Colorado Cancer Center||Denver, Colorado 80262|
|Cancer Research Center. University of Chicago Hospitals||Chicago, Illinois 60637|