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A Rollover Protocol For Patients Who Received CP-675,206 In Other Protocols


Phase 2
N/A
N/A
Open (Enrolling)
Both
Colorectal Neoplasms, Melanoma, Prostatic Neoplasms, Renal Cell Carcinoma, Neoplasms, Patients Who Have/Have Had Melanoma and Other Tumors

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Trial Information

A Rollover Protocol For Patients Who Received CP-675,206 In Other Protocols


Inclusion Criteria:



- The subject must have already received CP-675,206 in another protocol

- Females of childbearing potential must agree to practice a form of effective
contraception for 12 months following any dose of study drug. The definition of
effective contraception will be based on the judgement of the investigator.

- Subject must be willing and able to provide written informed consent and to comply
with scheduled visits and other trial procedures

Exclusion Criteria:

- None

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety Endpoints: • Serious adverse events • Grade 3 or 4 CP-675,206-related adverse events • Immune-mediated adverse events • Hypersensitivity reactions to CP-675,206

Outcome Time Frame:

as long as required

Safety Issue:

Yes

Principal Investigator

Ramy Ibrahim, Senior Director

Investigator Role:

Study Director

Investigator Affiliation:

MedImmune LLC

Authority:

United States: Food and Drug Administration

Study ID:

D4881C00024

NCT ID:

NCT00378482

Start Date:

March 2008

Completion Date:

November 2014

Related Keywords:

  • Colorectal Neoplasms
  • Melanoma
  • Prostatic Neoplasms
  • Renal Cell Carcinoma
  • Neoplasms
  • Patients Who Have/Have Had Melanoma and Other Tumors
  • Melanoma and other tumors
  • Neoplasms
  • Carcinoma
  • Carcinoma, Renal Cell
  • Colorectal Neoplasms
  • Melanoma
  • Prostatic Neoplasms

Name

Location

Research SiteAlabaster, Alabama  
Research SiteBentonville, Arkansas  
Research SiteAnaheim, California  
Research SiteBoulder, Colorado  
Research SiteBoca Raton, Florida  
Research SiteBloomington, Indiana  
Research SiteBattle Kreek, Michigan  
Research SiteAlbany, New York  
Research SiteAllentown, Pennsylvania  
Research SiteAbilene, Texas  
Research SiteAppleton, Wisconsin