START- South Texas Accelerated Research Therapeutics, LLC
San Antonio, Texas, 78229, United States
NCT Number: NCT01299636
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.
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Notify Me18 year and older
All sexes
Interventional
Phase 1
San Antonio, Texas, 78229, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: From treatment onset to end of treatment
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.
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.
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.
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.
Antitumor activity will be measured according to the RECIST (Response Evaluation Criteria In Solid Tumors) version 1.1 or by evaluation of tumor markers
PharmaMar
Industry
Phase I, Multicenter, Open-label, Dose-escalating, Clinical and Pharmacokinetic Study of PM060184 Administered Intravenously to Patients With Advanced Solid Tumors
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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