CompletedPhase 2ACTRN12609000815268

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

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

Sponsor

Piramal Enterprises Limited

Enrollment

36 participants

Start Date

Sep 10, 2009

Study Type

Interventional

Conditions

Malignant Melanoma

Summary

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.

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study tests an experimental drug called P276-00 in adults aged 18 and older with advanced melanoma (stage III unresectable or stage IV) that has not responded to standard treatments. The melanoma must test positive for a protein called cyclin D1.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

P276-00 is a novel potent small molecule flavone derived Cyclin dependent kinase (Cdk) Cdk 4-D1, Cdk1-B and Cdk9-T inhibitor. 185 mg/ml2 of P276-00 (in 200 mL of 5% Dextrose) will be administered o

P276-00 is a novel potent small molecule flavone derived Cyclin dependent kinase (Cdk) Cdk 4-D1, Cdk1-B and Cdk9-T inhibitor. 185 mg/ml2 of P276-00 (in 200 mL of 5% Dextrose) will be administered once daily to participants by intravenous (i.v.) infusion over 30 minutes from day 1 to day 5 of each 21-day cycle until objective or clinical evidence of progression of disease or occurrence of an unacceptable toxicity.