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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00835419




Registration number
NCT00835419
Ethics application status
Date submitted
2/02/2009
Date registered
2/02/2009
Date last updated
3/12/2012

Titles & IDs
Public title
Efficacy Study Of P276-00 In Subjects Of Malignant Melanoma Positive For Cyclin D1 Expression
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
Secondary ID [1] 0 0
P276-00/27/08
Universal Trial Number (UTN)
Trial acronym
ENVER
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Melanoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Malignant melanoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - P276-00

Experimental: 1 - P276-00 investigational product (small molecule Cdk 4-D1, Cdk1-B and Cdk9-T inhibitor)


Treatment: Drugs: P276-00
P276-00 -small molecule Cdk 4-D1, Cdk1-B and Cdk9-T inhibitor

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression Free Survival rate at Day 168
Timepoint [1] 0 0
168 days
Secondary outcome [1] 0 0
Overall survival rate at 1 year, objective response rate,duration of response
Timepoint [1] 0 0
1 year

Eligibility
Key inclusion criteria
1. Subject with histologically confirmed stage III (unresectable) or stage IV metastatic
melanoma as per revised 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 IL-2

4. 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]

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 = 9 g/dL

- Absolute Neutrophil count = 1,500/mm3

- Platelets = 100,000/mm3

- Total bilirubin = 1.5 X institutional upper limit of normal (ULN)

- AST/ALT = 2.5 X institutional ULN or = 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 CNS metastasis without evidence of recurrence for 12 week or more

- Brain metastasis treated by radiosurgery without evidence of recurrence or
progression for 12 week or more

- Multiple brain lesions treated with whole brain radiation therapy (WBRT) with
stable disease off corticosteroids for 12 week or more prior to start of therapy

10. Ability to understand and the willingness to sign a written informed consent document.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
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 (AE ³ CTCAE Grade 2) due to agents
administered more than 4 week 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 > 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
Purpose of the study
Treatment
Allocation to intervention
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
University of Newcastle, School of Medicine and Public Health - Newcastle
Recruitment hospital [2] 0 0
Mater Adult Hospital Raymond Tce South Brisbane, QLD 4101 - Brisbane
Recruitment hospital [3] 0 0
Peninsula Oncology Centre - Frankston
Recruitment hospital [4] 0 0
John Fawkner Cancer Trial Centre - Victoria
Recruitment postcode(s) [1] 0 0
2300 - Newcastle
Recruitment postcode(s) [2] 0 0
- Brisbane
Recruitment postcode(s) [3] 0 0
3199 - Frankston
Recruitment postcode(s) [4] 0 0
3058 - Victoria
Recruitment outside Australia
Country [1] 0 0
India
State/province [1] 0 0
Maharashtra
Country [2] 0 0
India
State/province [2] 0 0
Uttar Pradesh
Country [3] 0 0
New Zealand
State/province [3] 0 0
Christchurch

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Piramal Enterprises Limited
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to evaluate efficacy of P276-00 in subjects with advanced
malignant melanoma positive for cyclin D1 expression
Trial website
https://clinicaltrials.gov/show/NCT00835419
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Peter Hersey, MD
Address 0 0
Newcastle University
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications