Study of PM060184 in Patients With Advanced Solid Tumors
The purpose of the study is to determine the maximum tolerated dose and the recommended dose and to evaluate the safety and tolerability of PM060184.
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
|Official Title:||Phase I, Multicenter, Open-label, Dose-escalating, Clinical and Pharmacokinetic Study of PM060184 Administered Intravenously to Patients With Advanced Solid Tumors|
- MTD (maximum tolerated dose) and RD (recommended dose) of PM060184. [ Time Frame: From treatment onset to end of treatment ] [ Designated as safety issue: Yes ]To determine the maximum tolerated dose (MTD) and the recommended dose (RD) of PM060184 administered on Days 1 and 8 of a 21-day cycle intravenously (i.v.) over 10 minutes to patients with advanced solid tumors.
- To determine the pharmacokinetics of this drug in patients who have advanced solid tumors. [ Time Frame: Blood samples will be collected up to 48 hours after the first infusion. At the RD, 24-h urine collection samples and 15 additional blood samples up to 48 hours after the second infusion of the first cycle. ] [ Designated as safety issue: No ]The complete plasma concentration-time profiles of PM06184 will be analyzed by standard non-compartmental methods.The percent of PM060184 total dose excreted unchanged into the urine over the collection interval will be calculated from the urine samples.
- Antitumor activity [ Time Frame: Every six weeks while on treatment. Patients who discontinued treatment without disease progression will be followed every three months until disease progression, other antitumor therapy, death or until the end-of-study date, whichever occurs first. ] [ Designated as safety issue: No ]Antitumor activity will be measured according to the RECIST (Response Evaluation Criteria In Solid Tumors) version 1.1 or by evaluation of tumor markers
|Study Start Date:||January 2011|
|Estimated Primary Completion Date:||August 2015 (Final data collection date for primary outcome measure)|
PM060184 administered intravenously (i.v.) over 10 minutes at a starting dose of 4 mg/m2/day on three consecutive days q2w (on Days 1-3 and 15-17) every 28 days.
This trial intends to determine the maximum tolerated dose and the recommended dose, to evaluate the safety and tolerability, to determine the pharmacokinetics and to evaluate the antitumor activity of PM060184 in patients with advanced solid tumors.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01299636
|United States, Texas|
|START- South Texas Accelerated Research Therapeutics, LLC|
|San Antonio, Texas, United States, 78229|
|Principal Investigator:||Kyriakos Papadopoulos, MD||START- South Texas Accelerated Research Therapeutics, LLC|