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

Solid Tumor Clinical Trial

Official title:
An Open Label, Multicenter Phase I Study Of Selective Cyclin Dependent Kinase Inhibitor P1446A-05 In Subjects With Advanced Refractory Malignancies

Clinical Trial 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.

Clinical Trial Description

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 as per selection criteria. Starting dose for P1446A-05 in this study is 75 mg orally once daily for 14 days followed by 7 days rest. This constitutes one cycle for P1446A-05.Three patients will be enrolled in first cohort at this starting dose of P1446A-05. If this dose is well tolerated then dose escalation will be undertaken for subsequent cohorts as per accelerated titration design as described in protocol till maximum tolerated dose(MTD) for P1446A-05 is determined. The MTD will be the recommended phase 2 dose. 10 additional patients might be enrolled at this MTD to further evaluate safety and efficacy. 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. ;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00840190
Study type Interventional
Source Piramal Enterprises Limited
Contact
Status Completed
Phase Phase 1
Start date December 2008
Completion date September 2011
View Details
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