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Brief Title: Efficacy Study Of P276-00 In Subjects Of Malignant Melanoma Positive For Cyclin D1 Expression
Official Title: 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
Study ID: NCT00835419
Brief 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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
University of Newcastle, School of Medicine and Public Health, Newcastle, New South Wales, Australia
Mater Adult Hospital Raymond Tce South Brisbane, QLD 4101, Brisbane, , Australia
Peninsula Oncology Centre, Frankston, , Australia
John Fawkner Cancer Trial Centre, Victoria, , Australia
Curie Manavata Cancer Center, Nasik, Maharashtra, India
Chhatrapati Shahuji Maharaj Medical University, Lucknow, Uttar Pradesh, India
Christchurch Oncology Research Unit, Oncology Service, Christchurch Hospital, Riccarton Avenue, Private Bag 4710, Christchurch,, Christchurch, , New Zealand
Name: Peter Hersey, MD
Affiliation: Newcastle University
Role: PRINCIPAL_INVESTIGATOR