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| Sponsor: | Piramal Healthcare Limited |
|---|---|
| Information provided by (Responsible Party): | Piramal Healthcare Limited |
| ClinicalTrials.gov Identifier: | NCT00835419 |
Purpose
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 |
|---|---|---|
|
Melanoma |
Drug: P276-00 |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
| Primary Completion Date: | April 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
P276-00 investigational product (small molecule Cdk 4-D1, Cdk1-B and Cdk9-T inhibitor)
|
Drug: P276-00
P276-00 -small molecule Cdk 4-D1, Cdk1-B and Cdk9-T inhibitor
Other Name: P276-00
|
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| 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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Contacts and Locations| Australia, New South Wales | |
| University of Newcastle, School of Medicine and Public Health | |
| Newcastle, New South Wales, Australia, 2300 | |
| Australia | |
| Mater Adult Hospital Raymond Tce South Brisbane, QLD 4101 | |
| Brisbane, Australia | |
| Peninsula Oncology Centre | |
| Frankston, Australia, 3199 | |
| John Fawkner Cancer Trial Centre | |
| Victoria, Australia, 3058 | |
| India | |
| Curie Manavata Cancer Center | |
| Nasik, Maharashtra, India, 422 004 | |
| Chhatrapati Shahuji Maharaj Medical University | |
| Lucknow, Uttar Pradesh, India, 22600 | |
| New Zealand | |
| Christchurch Oncology Research Unit, Oncology Service, Christchurch Hospital, Riccarton Avenue, Private Bag 4710, Christchurch, | |
| Christchurch, New Zealand | |
| Principal Investigator: | Peter Hersey, MD | Newcastle University |
More Information
| Responsible Party: | Piramal Healthcare Limited |
| ClinicalTrials.gov Identifier: | NCT00835419 History of Changes |
| Other Study ID Numbers: | P276-00/27/08 |
| Study First Received: | February 2, 2009 |
| Last Updated: | January 10, 2012 |
| Health Authority: | Australia: Department of Health and Ageing Therapeutic Goods Administration |
|
metastatic malignant melanoma with cyclin D1 positivity |
|
Melanoma Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal |
Neoplasms by Histologic Type Neoplasms Neoplasms, Nerve Tissue Nevi and Melanomas |