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An Open Label, Randomized Clinical Comparability Study Of The Current Liquid And Commercial Liquid Formulations


Phase 1
18 Years
N/A
Not Enrolling
Both
Melanoma

Thank you

Trial Information

An Open Label, Randomized Clinical Comparability Study Of The Current Liquid And Commercial Liquid Formulations


Inclusion Criteria:



- Stage III or Stage IV melanoma

- No evidence of disease following resection of melanoma lesions

- Recovered from all prior surgical or adjuvant treatment-related toxicities

Exclusion Criteria:

- History of chronic inflammatory or autoimmune disease

- History of inflammatory bowel disease

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Pharmacokinetics: maximum plasma concentration of CP-675,206

Outcome Time Frame:

1 hour

Safety Issue:

No

Authority:

United States: Food and Drug Administration

Study ID:

A3671011

NCT ID:

NCT00431275

Start Date:

June 2006

Completion Date:

February 2008

Related Keywords:

  • Melanoma
  • Melanoma

Name

Location

Research SiteMesa, Arizona  
Research SiteBoulder, Colorado  
Research SiteBoca Raton, Florida  
Research SiteAlbany, Georgia  
Research SiteAlbany, New York  
Research SiteAllentown, Pennsylvania