This will show if CP-675,206 can be administered safely as an intravenous infusion lasting one hour. CP 675,206 already has been administered to 835 subjects over 1.0 - 7.5 hours.
This study was prematurely discontinued on April 28, 2008 because a concomitant Phase 3 study met pre-specified futility criteria. The decision to close enrollment early was not based on any safety concerns.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
49
15 mg/kg. IV (in the vein) over 1 hour on Day 1 of each 90 day cycle. Number of cycles: maximum of 4 cycles unless progression of disease or unacceptable toxicity.
Research Site
Scottsdale, Arizona, United States
Research Site
Los Angeles, California, United States
Research Site
Los Angeles, California, United States
Research Site
Aurora, Colorado, United States
To assess safety and tolerability during and for 1 hour following a 15 mg/kg dose of CP 675,206 administered as a one hour infusion.
Time frame: Last patient dosed = 31Dec2009
To monitor for human anti human (HAHA) response to CP 675,206
Time frame: Last HAHA time point obtain =estimated 31Dec2009
To assess evidence of anti tumor activity as measured by best overall response rate using Response Evaluation Criteria in Solid Tumors (RECIST) criteria, duration of response, progression free survival
Time frame: Last RECIST obtained = estimated 31Dec2009
To identify potential relationships between polymorphisms in the Cytotoxic T lymphocyte associated antigen 4 (CTLA4), Fcgamma receptor IIa (FcgRIIa), IgG2a genes with safety and/or immune response of subjects treated with CP 675,206
Time frame: Last PG obtained = estimated 31Dec2009
To evaluate the overall safety and tolerability of CP 675,206 in this population
Time frame: Last patient dosed = estimated 31Dec2009
To characterize the pharmacokinetics (PK) of CP 675,206 following a one hour infusion
Time frame: Last PK timepoint obtained =estiamted 31Dec2009
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Research Site
Atlanta, Georgia, United States
Research Site
Indianapolis, Indiana, United States
Research Site
Louisville, Kentucky, United States
Research Site
Durham, North Carolina, United States