NCT00840190

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: Piramal Enterprises Limited · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Solid Tumor
• Hematologic Malignancy

Interventions

Type	Name	Description
DRUG	P1446A-05	P1446A-05 available as 25mg,50mg,100mg capsule. Subjects will be enrolled at at different dose levels of P1446A-05 to be taken once a day for 14 days followed by 7 days rest.This constitutes one cycle of P1446A-05. Four such cycles will be administered.

Timeline

• Start date: 2008-12-01
• Primary completion: 2011-03-01
• Completion: 2011-09-01
• First posted: 2009-02-10
• Last updated: 2012-11-21

Locations

5 sites across 1 country: India