NCT00835419

Efficacy Study Of P276-00 In Subjects Of Malignant Melanoma Positive For Cyclin D1 Expression

An Open Label, Multicentre, Two Stage, Phase II Study To Evaluate Efficacy And Safety Of P276-00 In Subjects Of Malignant Melanoma Positive For Cyclin D1 Expression

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Piramal Enterprises Limited · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate efficacy of P276-00 in subjects with advanced malignant melanoma positive for cyclin D1 expression

Detailed description

Currently, melanoma is the fifth most common cancer diagnosed in men and the seventh most common cancer diagnosed in women.Advanced melanoma has a very poor prognosis.For a vast majority of subjects with malignant melanoma, there are no effective therapies.Therefore, the development of effective therapies for this subject population remains a priority in oncology.In a limited study in melanomas, increased cyclin D1 protein expression, as was observed in 33% cases.P276-00 is a novel potent small molecule flavone derived Cyclin dependent kinase (Cdk) Cdk 4-D1, Cdk1-B and Cdk9-T inhibitor.P276-00 demonstrated significant and selective antiproliferative effect against melanoma cell lines.

Conditions

• Melanoma

Interventions

Type	Name	Description
DRUG	P276-00	P276-00 -small molecule Cdk 4-D1, Cdk1-B and Cdk9-T inhibitor

Timeline

• Start date: 2009-05-01
• Primary completion: 2011-04-01
• Completion: 2012-11-01
• First posted: 2009-02-03
• Last updated: 2012-12-04

Locations

7 sites across 3 countries: Australia, India, New Zealand