Treatment Use Study for Advanced Melanoma.
Expanded access is no longer available for this treatment.
Information provided by:
First received: December 21, 2007
Last updated: December 11, 2009
Last verified: December 2009
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.
Advanced Unresectable Melanoma
What is Expanded Access?
||Treatment Use Study of CP-675,206 for Advanced Melanoma
| Study Start Date:
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.
This is an expanded access trial that canceled prior to enrolling patients.
|Ages Eligible for Study:
||18 Years and older (Adult, Senior)
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00584493
||Pfizer CT.gov Call Center
||Director, Clinical Trial Disclosure Group, Pfizer Inc
History of Changes
|Other Study ID Numbers:
|Study First Received:
||December 21, 2007
||December 11, 2009
||United States: Food and Drug Administration
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on October 21, 2016
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Physiological Effects of Drugs