drugset / Trial / NCT00840190

A Study Of Selective Cyclin Dependent Kinase Inhibitor P1446A-05 In Subjects With Advanced Refractory Malignancies

NCT00840190

Phase 1 Completed 29 enrolled Piramal Enterprises Limited
Non-randomizedSingle-groupOpen-labelTreatment

Summary

This is a phase I open label study to evaluate safety and efficacy of P1446A-05 in subjects with advanced refractory malignancies. Subjects of solid tumors or hematologic malignancies will be included. This is a dose escalation study following an accelerated titration design. It is expected that around 50 subjects would be enrolled in the study.Safety assessment will be conducted on the basis of vital signs, physical examination and laboratory investigations undertaken at regular intervals as per the schedule.

Timeline

Start
2008-12
Primary completion
2011-03
Completion
2011-09

Drugs

EvaluationDrugModalityDoseRoute
Subject P1446A-05 Unknown 75 mg Oral