Back to resultsTreatment Use Study for Advanced Melanoma.
Primary Purpose
Advanced Unresectable Melanoma
Status
No longer available
Phase
Locations
Study Type
Expanded Access
Intervention
CP-675,206
Sponsored by
About this trial
This is an expanded access trial for Advanced Unresectable Melanoma
Eligibility Criteria
Inclusion Criteria:
- 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:
- 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.
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00584493
Brief Title
Treatment Use Study for Advanced Melanoma.
Official Title
Treatment Use Study of CP-675,206 for Advanced Melanoma
Study Type
Expanded Access
2. Study Status
Record Verification Date
December 2009
Overall Recruitment Status
No longer available
Study Start Date
May 2008 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Pfizer
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Unresectable Melanoma
7. Study Design
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
CP-675,206
Intervention Description
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
12. IPD Sharing Statement
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A3671028&StudyName=Treatment%20Use%20Study%20for%20Advanced%20Melanoma.
Description
To obtain contact information for a study center near you, click here.
Learn more about this trial
Treatment Use Study for Advanced Melanoma.
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