CompletedPhase 2

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

Australia, India12 participantsStarted 2009-05

Plain-language summary

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

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Subject with histologically confirmed stage III (unresectable) or stage IV metastatic melanoma as per revised AJCC melanoma staging
✓. Subject positive for cyclin D1 expression by appropriate technique
✓. Subject with at least one metastasis in which surgery was not a curative option and had relapsed from, or had not responded to at least one regimen containing Dacarbazine and or IL-2
✓. Subjects with measurable disease \[at least one unidimensionally measurable lesion ³ 20 mm with conventional techniques (CT, MRI, X-ray) or ³ 10 mm by spiral CT scan\]
✓. Subject of either sex and 18 years of age or elder
✓. Eastern Cooperative Oncology Group (ECOG) performance status 2 or less
✓. Subject with life expectancy of at least 4 months
✓. Subject must have normal organ and marrow function as defined below

✕. Treatment with P276?00 or other cyclin dependent kinase (CDK) targeting agents anytime in the past
✕. History of allergic reactions attributed to compounds of chemical composition similar to P276?00
✕. Subject who have had chemotherapy, immunotherapy or radiotherapy within 4 week prior to first dosing of study agent. For nitrosoureas, there shall be interval of at least six week from first dosing of study agent
✕. Subject who have not recovered from adverse events (AE ³ CTCAE Grade 2) due to agents administered more than 4 week earlier.
✕. Subject who had received any other investigational drug within 1 month prior to day 1 of study drug administration
✕. Prior malignancy (within the last 3 years) except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, in situ breast cancer, in situ prostate cancer or any other cancer for which the subject has been disease-free for at least 3 years
✕. Any medical condition (such as but not limited to severe/unstable angina, history of myocardial infarction, coronary/peripheral artery bypass graft, symptomatic congestive cardiac failure, cerebrovascular accident or transient ischemic attack, pulmonary embolism) or laboratory abnormality(ies) which might make it difficult for the subject to participate in the study, at the discretion of the Principal Investigator (PI)or co-PI
✕. Known human immunodeficiency virus (HIV) positivity or acquired immunodeficiency syndrome (AIDS) related illness

Progression Free Survival rate at Day 168

Timeframe: 168 days

NCT IDNCT00835419

SponsorPiramal Enterprises Limited

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2011-04

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Subject with histologically confirmed stage III (unresectable) or stage IV metastatic melanoma as per revised AJCC melanoma staging
✓. Subject positive for cyclin D1 expression by appropriate technique
✓. Subject with at least one metastasis in which surgery was not a curative option and had relapsed from, or had not responded to at least one regimen containing Dacarbazine and or IL-2
✓. Subjects with measurable disease \[at least one unidimensionally measurable lesion ³ 20 mm with conventional techniques (CT, MRI, X-ray) or ³ 10 mm by spiral CT scan\]
✓. Subject of either sex and 18 years of age or elder
✓. Eastern Cooperative Oncology Group (ECOG) performance status 2 or less
✓. Subject with life expectancy of at least 4 months
✓. Subject must have normal organ and marrow function as defined below

✕. Treatment with P276?00 or other cyclin dependent kinase (CDK) targeting agents anytime in the past
✕. History of allergic reactions attributed to compounds of chemical composition similar to P276?00
✕. Subject who have had chemotherapy, immunotherapy or radiotherapy within 4 week prior to first dosing of study agent. For nitrosoureas, there shall be interval of at least six week from first dosing of study agent
✕. Subject who have not recovered from adverse events (AE ³ CTCAE Grade 2) due to agents administered more than 4 week earlier.
✕. Subject who had received any other investigational drug within 1 month prior to day 1 of study drug administration
✕. Prior malignancy (within the last 3 years) except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, in situ breast cancer, in situ prostate cancer or any other cancer for which the subject has been disease-free for at least 3 years
✕. Any medical condition (such as but not limited to severe/unstable angina, history of myocardial infarction, coronary/peripheral artery bypass graft, symptomatic congestive cardiac failure, cerebrovascular accident or transient ischemic attack, pulmonary embolism) or laboratory abnormality(ies) which might make it difficult for the subject to participate in the study, at the discretion of the Principal Investigator (PI)or co-PI
✕. Known human immunodeficiency virus (HIV) positivity or acquired immunodeficiency syndrome (AIDS) related illness