An Open Label, Multicenter Phase I Study Of Selective Cyclin Dependent Kinase Inhibitor P1446A-05 In Subjects With Advanced Refractory Malignancies
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.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine the maximum tolerated dose (MTD) and dose limiting toxicities (DLT) of P1446A-05 in subjects with advanced refractory malignancies
End of cycle 1 (3 weeks)
Yes
Minish Jain, M.D.
Principal Investigator
Consultant
India: Drugs Controller General of India
P1446A-05/19/08
NCT00840190
December 2008
September 2011
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