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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00254579




Registration number
NCT00254579
Ethics application status
Date submitted
14/11/2005
Date registered
16/11/2005
Date last updated
7/06/2012

Titles & IDs
Public title
Study of CP-675,206 in Refractory Melanoma
Scientific title
A Phase 2, Open Label, Single Arm Study To Evaluate The Efficacy, Safety, Tolerability And Pharmacokinetics Of CP-675,206 In Patients With Advanced Refractory And/Or Relapsed Melanoma
Secondary ID [1] 0 0
A3671008
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Refractory 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 - CP-675,206

Experimental: 15 mg/kg CP-675,206 -


Treatment: Drugs: CP-675,206
15 mg/kg Q12W dosing regimen
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
To assess the anti-tumor efficacy, as determined by objective response rate, of intravenous CP-675,206 administered at a dose of 15 mg/kg every 90 days to patients with relapsed or refractory advanced melanoma
Timepoint [1] 0 0
Tumor response is assessed every 2-3 months until disease progression
Secondary outcome [1] 0 0
Safety
Timepoint [1] 0 0
At every scheduled visit as specified per protocol for a maximum of 2 years from first dose of drug
Secondary outcome [2] 0 0
Pharmaco Kinetic
Timepoint [2] 0 0
At every scheduled visit as specified per protocol for a maximum of 2 years from first dose of drug
Secondary outcome [3] 0 0
Survival
Timepoint [3] 0 0
At every scheduled visit as specified per protocol for a maximum of 2 years from first dose of drug
Secondary outcome [4] 0 0
Health-related QoL
Timepoint [4] 0 0
At every scheduled visit as specified per protocol for a maximum of 2 years from first dose of drug

Eligibility
Key inclusion criteria
* Surgically incurable Stage III or IV melanoma
* One prior systemic treatment for metastatic melanoma
* Measurable disease
* Eastern Cooperative Oncology Group (ECOG) PS = 0 or 1
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Melanoma of ocular origin
* Received prior vaccine
* Received prior CTLA4-inhibiting agent
* History of, or significant risk for, chronic inflammatory or autoimmune disease
* Potential requirement for systemic corticosteroids

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
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
1/12/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2009
Sample size
Target
Accrual to date
Final
251
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
Research Site - Waratah
Recruitment hospital [2] 0 0
Research Site - Westmead
Recruitment hospital [3] 0 0
Research Site - Woolloongabba
Recruitment hospital [4] 0 0
Research Site - East Melbourne
Recruitment hospital [5] 0 0
Research Site - Nedlands
Recruitment postcode(s) [1] 0 0
2298 - Waratah
Recruitment postcode(s) [2] 0 0
2145 - Westmead
Recruitment postcode(s) [3] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [4] 0 0
3002 - East Melbourne
Recruitment postcode(s) [5] 0 0
6009 - Nedlands
Recruitment outside Australia
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United States of America
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Arizona
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Arkansas
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California
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Colorado
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Connecticut
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Florida
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Illinois
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Indiana
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Kentucky
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Maryland
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Massachusetts
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Michigan
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New York
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North Carolina
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Ohio
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Pennsylvania
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Tennessee
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Utah
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Washington
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Wisconsin
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Argentina
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Buenos Aires
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Canada
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Ontario
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France
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Cedex
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France
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Paris Cedex 13
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France
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Villejuif
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Germany
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Berlin
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Germany
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Frankfurt
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Germany
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Kiel
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Germany
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Tuebingen
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Italy
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Meldola, FC
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Italy
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Milano
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Spain
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Navarra
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Spain
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Barcelona
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Spain
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Madrid
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Spain
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Zaragoza
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United Kingdom
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Cornwall
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United Kingdom
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Middlesex
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United Kingdom
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Surrey
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United Kingdom
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Tyne and Wear
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United Kingdom
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London
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United Kingdom
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Manchester
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United Kingdom
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Newcastle Upon Tyne

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AstraZeneca
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
CP-675,206 is a fully human monoclonal antibody (mAb). It binds to the CTLA4 molecule, which is expressed on the surface of activated T lymphocytes. CP-675,206 is thought to stimulate patients' immune systems to attack their tumors. CP-675,206 is not expected to have a direct effect on tumor cells. CP-675,206 been shown to induce durable tumor responses in patients with metastatic melanoma in Phase 1 and Phase 2 clinical studies.
Trial website
https://clinicaltrials.gov/study/NCT00254579
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
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

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00254579