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Sponsored by: |
Piramal Life Sciences Limited |
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Information provided by: | Piramal Life Sciences Limited |
ClinicalTrials.gov Identifier: | NCT00835419 |
The purpose of this study is to evaluate efficacy of P276-00 in subjects with advanced malignant melanoma positive for cyclin D1 expression
Condition | Intervention | Phase |
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Melanoma |
Drug: P276-00 |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
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 |
Estimated Enrollment: | 36 |
Study Start Date: | May 2009 |
Estimated Primary Completion Date: | May 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
P276-00 investigational product (small molecule Cdk 4-D1, Cdk1-B and Cdk9-T inhibitor)
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Drug: P276-00
P276-00 -small molecule Cdk 4-D1, Cdk1-B and Cdk9-T inhibitor
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Subject must have normal organ and marrow function as defined below
Subjects with metastatic disease to the central nervous system will be included provided they had either:
Exclusion Criteria:
Women of childbearing potential [defined as a sexually mature woman who has not undergone hysterectomy or who has not been naturally postmenopausal for at least 24 consecutive months (i.e. who has had menses any time in the preceding 24 consecutive months)] and men, not agreeing to use adequate contraception (e.g., hormonal or barrier method of birth control or abstinence) after signing an informed consent document (ICD), during the duration of study participation and for at least 4 week after withdrawal from the study, unless they are surgically sterilized
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Australia, New South Wales | |
University of Newcastle, School of Medicine and Public Health | |
Newcastle, New South Wales, Australia, 2300 |
Principal Investigator: | Peter Hersey, MD | University of Newcastle |
Responsible Party: | Piramal Life Sciences Limited ( Dr Himanshu Parikh ) |
Study ID Numbers: | P276-00/27/08 |
Study First Received: | February 2, 2009 |
Last Updated: | May 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00835419 History of Changes |
Health Authority: | Australia: Department of Health and Ageing Therapeutic Goods Administration |
metastatic malignant melanoma with cyclin D1 positivity |
Neuroectodermal Tumors Nevus, Pigmented Neoplasms, Germ Cell and Embryonal Neuroepithelioma |
Nevus Neuroendocrine Tumors Melanoma |
Neuroectodermal Tumors Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal |
Neoplasms, Nerve Tissue Nevi and Melanomas Neuroendocrine Tumors Melanoma |