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Trial registered on ANZCTR
Registration number
ACTRN12609000815268
Ethics application status
Approved
Date submitted
2/06/2009
Date registered
18/09/2009
Date last updated
19/02/2014
Type of registration
Retrospectively registered
Titles & IDs
Public title
Efficacy Study Of P276-00 In Subjects Of Malignant Melanoma Positive For Cyclin D1 Expression (ENVER)
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Scientific 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
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Secondary ID [1]
910
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registered ClinicalTrials.gov ID NCT00835419
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Universal Trial Number (UTN)
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Trial acronym
ENVER
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Malignant Melanoma
236902
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Condition category
Condition code
Cancer
237254
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0
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Malignant melanoma
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
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.
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Intervention code [1]
236688
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Treatment: Drugs
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Comparator / control treatment
NA
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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Progression Free Survival rate (using Response Evaluation Criteria In Solid Tumours (RECIST) criteria) at Day 168
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Assessment method [1]
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Timepoint [1]
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Time Frame: 168 days following commencement of treatment.
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.
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Secondary outcome [1]
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Overall survival rate at 1 year (all cause mortality assessed through medical records)
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Assessment method [1]
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Timepoint [1]
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Time Frame: 1 year following commencement of treatment
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Secondary outcome [2]
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Objective response rate (via RECIST criteria)
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Assessment method [2]
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Timepoint [2]
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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.
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Secondary outcome [3]
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Duration of response (via RECIST criteria)
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Assessment method [3]
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Timepoint [3]
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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.
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Eligibility
Key inclusion criteria
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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 2
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
1/05/2009
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Actual
10/09/2009
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Date of last participant enrolment
Anticipated
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Actual
23/05/2012
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
36
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
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Recruitment postcode(s) [1]
1782
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2298
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Recruitment postcode(s) [2]
1783
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2145
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Recruitment postcode(s) [3]
1784
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2500
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Recruitment postcode(s) [4]
1785
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2640
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Recruitment postcode(s) [5]
1786
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3058
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Recruitment postcode(s) [6]
1787
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3199
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Recruitment postcode(s) [7]
1788
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4101
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Recruitment outside Australia
Country [1]
1823
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New Zealand
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State/province [1]
1823
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Christchurch
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Funding & Sponsors
Funding source category [1]
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Commercial sector/Industry
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Name [1]
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Piramal Life Sciences Limited
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Address [1]
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1, Nirlon Complex, Off Western Express Highway, Near NSE Complex, Goregaon (East), Mumbai 400 063, India
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Country [1]
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India
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Primary sponsor type
Commercial sector/Industry
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Name
Piramal Enterprises Limited
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Address
Piramal Enterprises Limited, Nirlon Complex Off Western Express Highway, Near NSE Complex, Goregaon (East), Mumbai 400 063
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Country
India
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Secondary sponsor category [1]
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Commercial sector/Industry
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Name [1]
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INCResearch Australia Pty. Ltd.
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Address [1]
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159 Port Road Hindmarsh, South Australia, 5007, Australia
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Country [1]
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
239177
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Hunter New England Human Research Ethics Committee
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Ethics committee address [1]
239177
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Locked Bag 1 Lookout Road
NEW LAMBTON
NSW 2305
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Ethics committee country [1]
239177
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Australia
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Date submitted for ethics approval [1]
239177
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Approval date [1]
239177
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28/04/2009
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Ethics approval number [1]
239177
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09/02/18/3.05
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Ethics committee name [2]
239178
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Bellbery Human Research Ethics Committee
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Ethics committee address [2]
239178
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229 Greenhill Road
Dulwich SA 5065
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Ethics committee country [2]
239178
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Australia
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Date submitted for ethics approval [2]
239178
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Approval date [2]
239178
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Ethics approval number [2]
239178
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A20/09A
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Ethics committee name [3]
239180
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Joint Hospitals Ethics Committee
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Ethics committee address [3]
239180
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Vermont Street,
Wodonga
Vic 3689
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Ethics committee country [3]
239180
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Australia
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Date submitted for ethics approval [3]
239180
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Approval date [3]
239180
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Ethics approval number [3]
239180
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JHEC:324/09/2
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Ethics committee name [4]
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Mater Health Services Human Research Ethics Committee
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Ethics committee address [4]
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Raymond Terrace, South Brisbane, Queensland, 4101
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Ethics committee country [4]
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Australia
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Date submitted for ethics approval [4]
290598
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Approval date [4]
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28/09/2009
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Ethics approval number [4]
290598
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Summary
Brief 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.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Prof Peter Hersey
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Address
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Newcastle Melanoma Unit Calvary Mater Newcastle Corner Edith and Platt Streets Waratah NSW 2298
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Country
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Australia
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Phone
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+61 (0)2 4923-6828
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Fax
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+61 (0)2 4923-6184
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Email
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[email protected]
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Contact person for public queries
Name
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Ms Laura Johnston
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Address
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INCResearch Australia Pty. Ltd., Suite 1, Level 2, 924 Pacific Highway Gordon NSW 2072
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Country
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Australia
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Phone
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+61 (0)414 480 069
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Fax
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+61 (0)7 3848-802
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Email
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[email protected]
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Contact person for scientific queries
Name
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Dr David Fuller
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Address
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INCResearch Australia Pty. Ltd., Suite 1, Level 2, 924 Pacific Highway Gordon NSW 2072
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Country
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Australia
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Phone
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+61 (0)2 8437 9238
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Fax
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+61 (0)2 8437 9299
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Email
3857
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[email protected]
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No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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