Treatment Use Study for Advanced Melanoma.

NCT00584493

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Advanced Unresectable Melanoma
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Advanced melanoma with life expectancy of at least 6 months.

- Melanoma must be considered unresectable.

- Patients with stable, treated brain mets must be stable clinically and radiographically and off steroids for at least one month.

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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- Patients must not be eligible for participation in any ongoing CP-675,206 clinical
studies currently open for enrollment.


- History of chronic inflammatory or autoimmune disease.


- History of inflammatory bowel disease, celiac disease, or other chronic
gastrointestinal conditions associated with diarrhea, active colitis, history of
diverticulitis.

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Advanced Unresectable MelanomaTreatment Use Study for Advanced Melanoma.
NCT00584493
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title Treatment Use Study for Advanced Melanoma.
Brief Summary The purpose of this study is to provide access to CP-675,206 for patients with advanced unresectable melanoma and who have the potential to gain benefit from this treatment and who are not eligible for participation in other CP-675,206 studies.
Detailed Description This is an expanded access trial that canceled prior to enrolling patients.
Study Type Expanded Access
Intervention Drug: CP-675,206

This is a single arm study. Patients will receive intravenous administration of CP-675,206 at a dose of 15 mg/kg on Day 1 of every 90-day cycle for up to 4 cycles. For purposes of treatment visits and scheduling, each cycle is defined as a 90 (± 4 day) period. Patients who discontinue treatment after 4 doses of CP-675,206 without disease progression and who subsequently experience disease progression more than 3 months after the last dose may receive 2 additional doses of CP-675,206 provided that they have not received other systemic therapy for their melanoma

Survival in this study will be monitored on all patients for up to 5 years from the date of first dose of CP-675,206.

Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Expanded Access Status No longer available
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT00584493
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer Inc
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date December 2009