A Multicenter Phase I Clinical Study of a New Compound P1446A-05 in Patients With Advanced Refractory Malignancies
Status:
Completed
Trial end date:
2012-05-01
Target enrollment:
Participant gender:
Summary
This is a phase I study of a novel compound P1446A-05. Aim of this study is to identify the
the recommended phase II dose of the drug and to determine the nature of adverse effects
associated with the drug. P1446A-05 capsules will be given continuously (28 days in each 28
day cycle) to patients suffering from advanced malignancies with no effective treatment
available. The dose of the study agent will be lower i.e. 75 mg per day for initial patients.
If this dose is found safe, higher dose will be administered to next set of (three to six)
patients. This will continued till the safest and best dose is identified. Treatment will be
given for 4 cycles and continued further if found effective. Dose schedule may be modified to
introduce treatment holiday,if frequent adverse effects are seen on continuous
administration.