This study will examine the safety profile of SGN-35 alone and in combination with gemcitabine. The study will test increasing doses of SGN-35 given weekly to small groups of patients.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
44
IV; 0.4 up to 1.8 mg/kg weekly 3 out of 4 weeks; minimum of two 28-day cycles
IV; 1000 mg/m2 weekly 3 out of 4 weeks
University of Alabama at Birmingham
Birmingham, Alabama, United States
Stanford University Medical Center
Palo Alto, California, United States
University of Miami
Miami, Florida, United States
Washington University School of Medicine
St Louis, Missouri, United States
Incidence of adverse events and laboratory abnormalities
Time frame: 1 month after last dose
PK profile
Time frame: 2 months after last dose
Immunogenicity (anti-SGN-35 antibodies)
Time frame: 1 month after last dose
Anti-tumor activity
Time frame: 1 month after last dose
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University of Texas MD Anderson Cancer Center
Houston, Texas, United States