Treatment Use Study for Advanced Melanoma.

Advanced Unresectable Melanoma Clinical Trial

Official title:

Treatment Use Study of CP-675,206 for Advanced Melanoma

Clinical Trial Details — Status: No longer available

Administrative data

• NCT number: NCT00584493
• Other study ID #: A3671028
• Status: No longer available
• Phase: Phase 3
• First received: December 21, 2007
• Last updated: December 11, 2009
• Start date: May 2008

Study information

• Verified date: December 2009
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Expanded Access

Clinical Trial 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.

Description:

This is an expanded access trial that canceled prior to enrolling patients.

Recruitment information / eligibility

• Status: No longer available
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

N/A

Related Conditions & MeSH terms

• Advanced Unresectable Melanoma
• Melanoma

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

External Links

•   To obtain contact information for a study center near you, click here.