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Treatment Use Study for Advanced Melanoma.

Expanded access is no longer available for this treatment.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00584493
First received: December 21, 2007
Last updated: December 11, 2009
Last verified: December 2009
  Purpose

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.


Condition Intervention Phase
Advanced Unresectable Melanoma
Drug: CP-675,206
Phase 3

Study Type: Expanded Access     What is Expanded Access?
Official Title: Treatment Use Study of CP-675,206 for Advanced Melanoma

Resource links provided by NLM:


Further study details as provided by Pfizer:

Study Start Date: May 2008
Intervention Details:
    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.

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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

Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer Inc
ClinicalTrials.gov Identifier: NCT00584493     History of Changes
Other Study ID Numbers: A3671028
Study First Received: December 21, 2007
Last Updated: December 11, 2009
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Melanoma
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Neuroectodermal Tumors
Neuroendocrine Tumors
Nevi and Melanomas

ClinicalTrials.gov processed this record on November 20, 2014