Efficacy Study Of P276-00 In Subjects Of Malignant Melanoma Positive For Cyclin D1 Expression (ENVER)
- Conditions
- Malignant MelanomaCancer - Malignant melanoma
- Registration Number
- ACTRN12609000815268
- Lead Sponsor
- Piramal Enterprises Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 36
Inclusion Criteria:
1. Subject with histologically confirmed stage III (unresectable) or stage IV metastatic melanoma as per revised American Joint Committee On Cancer (AJCC) melanoma staging
2. Subject positive for cyclin D1 expression by appropriate technique
3. 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 Interleukin (IL)-2
4. Subjects with measurable disease [at least one unidimensionally measurable lesion greater than or equal to 20 mm with conventional techniques (Computed Tomography (CT), Magnetic Resonance Imaging (MRI), X-ray) or greater than or equal to 10 mm by spiral (Computed Tomography (CT) scan]
5. Subject of either sex and 18 years of age or elder
6. Eastern Cooperative Oncology Group (ECOG) performance status 2 or less
7. Subject with life expectancy of at least 4 months
8. Subject must have normal organ and marrow function as defined below
- Hemoglobin greater than or equal to 9 g/dL
- Absolute Neutrophil count greater than or equal to 1,500/mm3
- Platelets greater than or equal to 100,000/mm3
- Total bilirubin less than or equal to 1.5 X institutional upper limit of normal (ULN)
- Aspartate Amino Transferase (AST)/ Alanine Amino Transferase (ALT) less than or equal to 2.5 X institutional upper limit of normal (ULN) or less than or equal to 5 X ULN if liver function abnormalities are due to underlying malignancy
- S. creatinine within 1.5 times the upper normal institutional limits
9. Subjects with metastatic disease to the central nervous system will be included provided they had either:
- No evidence of leptomeningeal disease
- Resected central nervous system (CNS) metastasis without evidence of recurrence for 12 week or more
- Brain metastasis treated by radiosurgery without evidence of recurrence or progression for 12 weeks or more
- Multiple brain lesions treated with whole brain radiation therapy (WBRT) with stable disease off corticosteroids for 12 weeks or more prior to start of therapy
10. Ability to understand and the willingness to sign a written informed consent document.
1. Treatment with P276-00 or other cyclin dependent kinase (CDK) targeting agents anytime in the past
2. History of allergic reactions attributed to compounds of chemical composition similar to P276-00
3. 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
4. Subject who have not recovered from adverse events (adverse event (AE) greater than or equal to Common Terminology Criteria for Adverse Event (CTCAE) Grade 2) due to agents administered more than 4 weeks earlier.
5. Subject who had received any other investigational drug within 1 month prior to day 1 of study drug administration
6. 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
7. 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
8. Known human immunodeficiency virus (HIV) positivity or acquired immunodeficiency syndrome (AIDS) related illness
9. QTc greater than 470 millisecond on 12 lead Electrocardiogram at screening
10. Pregnant or nursing women
11. 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Progression Free Survival rate (using Response Evaluation Criteria In Solid Tumours (RECIST) criteria) at Day 168[Time Frame: 168 days following commencement of treatment.<br><br>Tumour measurements will be undertaken via Computed Tomography (CT) scan at screening, at the end of every two cycles of treatment (6 weekly), at the end of study visit and at the 4 week follow-up visit.]
- Secondary Outcome Measures
Name Time Method Overall survival rate at 1 year (all cause mortality assessed through medical records)[Time Frame: 1 year following commencement of treatment];Objective response rate (via RECIST criteria)[Timeframe: Tumour measurements will be undertaken to assess objective response rate via CT scan at screening, at the end of every two cycles of treatment (6 weekly), at the end of study visit and at the 4 week follow-up visit.];Duration of response (via RECIST criteria)[Timeframe: Tumour measurements will be undertaken to assess duration of response via CT scan at screening, at the end of every two cycles of treatment (6 weekly), at the end of study visit and at the 4 week follow-up visit.]