drugset / Trial / NCT01380249

PDM08 Clinical Trial in Advanced Solid Tumors

NCT01380249 ↗

Phase 1 Completed 22 enrolled Prodimed S.A.
NaSingle-groupOpen-labelTreatment

Summary

This phase I study in adult patients with advanced solid tumours is designed to evaluate toxicity, drug exposure (pharmacokinetics) and drug action (pharmacodynamics) of a new molecule, PDM08, administered twice a week cycles of 4 weeks. This drug has shown antitumoral activity in several murine cancer models.

Timeline

Start
2011-06
Primary completion
2012-06
Completion
2013-01

Drugs

EvaluationDrugModalityDoseRoute
Subject PDM08 Unknown 560 ug —
Subject PDM08 Unknown 1.12 mg —
Subject PDM08 Unknown 2.24 mg —
Subject PDM08 Unknown 3.5 mg —
Subject PDM08 Unknown 14 mg —
Subject PDM08 Unknown 28 mg —
Subject PDM08 Unknown 56 mg —

Indications