ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
Adult Trials: 18+ Years
- 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.
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| 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 |
| |||
| PRS Account | Pfizer | |||
| Verification Date | December 2009 | |||