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MelanomaPhase 2ENVERNCT00835419

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

A Phase 2 study testing P276-00 in people with Melanoma, run by Piramal Enterprises Limited at 7 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 years and older
Conditions the study is for
Melanoma
What is being tested?
P276-00
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
7 sitesin 3 countries
Study dates
May 2009to Nov 2012
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • Subject with life expectancy of at least 4 months
  • 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
  • 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
  • Ability to understand and the willingness to sign a written informed consent document.

Who cannot join

  • 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
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  • 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
  • QTc > 470 millisecond on 12 lead Electrocardiogram at screening
  • Pregnant or nursing women
  • 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
  • -

Trial locations and contacts

7 sites in 3 countries.

7 sites in 3 countries

Australia4 sites

  • Mater Adult Hospital Raymond Tce South Brisbane, QLD 4101

    Brisbane

  • Peninsula Oncology Centre

    Frankston, 3199

  • University of Newcastle, School of Medicine and Public Health

    Newcastle, New South Wales, 2300

  • John Fawkner Cancer Trial Centre

    Victoria, 3058

Other trials in Australia

India2 sites

  • Chhatrapati Shahuji Maharaj Medical University

    Lucknow, Uttar Pradesh, 22600

  • Curie Manavata Cancer Center

    Nashik, Maharashtra, 422 004

Other trials in India

New Zealand1 site

  • Christchurch Oncology Research Unit, Oncology Service, Christchurch Hospital, Riccarton Avenue, Private Bag 4710, Christchurch,

    Christchurch

Other trials in New Zealand

About this study

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

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

Read the detailed description

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.

Conditions
Melanoma
Being tested
P276-00
Keywords
metastatic malignant melanoma with cyclin D1 positivity
Medical subject headings
Melanoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • P276-00Drug

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

Study groups in NCT00835419
Study groupRoleWhat they receive
1ExperimentalP276-00 investigational product (small molecule Cdk 4-D1, Cdk1-B and Cdk9-T inhibitor)
Receives: Drug: P276-00

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression Free Survival rate at Day 168

    Measured: 168 days

Secondary outcomes (1)

  1. Overall survival rate at 1 year, objective response rate,duration of response

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Feb 2009 (estimated)
  2. Study startMay 2009
  3. Primary completionApr 2011
  4. Study completionNov 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00835419
Sponsor's protocol ID
P276-00/27/08
Acronym
ENVER
Status last verified
Dec 2012
First submitted
2 Feb 2009
Last updated
4 Dec 2012
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing P276-00 in people with Melanoma, run by Piramal Enterprises Limited at 7 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 20 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in Australia, India, New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression Free Survival rate at Day 168 (time frame: 168 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00835419.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2012.

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