Phase I Study, Open, Dose Escalation, in Adult Patients With Advanced Solid Tumours, to Evaluate Tolerability, Pharmacokinetics and Pharmacodynamics of PDM08 Administered Twice a Week Cycles of 4 Weeks.
Phase I study, open, dose escalation, in adult patients with advanced solid tumours, to
evaluate tolerability, pharmacokinetics and pharmacodynamics of ascending PDM08 doses
administered twice a week cycles of 4 weeks.
After checking the safety of the first drug doses, a new dose escalation was proposed and
approved by the Ethic Committee and the Medicines Agency.
This clinical trial is carried out in adult patients with advanced solid tumours whose
disease has progressed despite standard therapy, or for which there is no standard
antineoplastic therapy, or are refractory to it.
In pharmacodynamic non clinical studies, PDM08 presented antitumour activity against
different tumour models including, renal, colon, lung, prostate and breast cancer models.
Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Number and grade of adverse events by participant related to PDM08.
Drug safety will be measured by the number and grade of adverse events, by participant, related to the drug in study (PDM08) in the cohorts studied: 560 μg, 1.12 mg, 2.24 mg, 3.5 mg and 14 mg, 28 mg and 56 mg administered twice a week for four weeks. The drug will be administered twice a week for four weeks. Safety and tolerability will be measured considering the adverse events occurred, by participant, related with the drug in study, PDM08, at each cohort.
6 weeks for each cohort.
Jorge Barriuso, MD, PhD
Hospital Universitario La Paz - Madrid (Spain)
Spain: Spanish Agency of Medicines