A study of ABT-414 in subjects with solid tumors.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
57
ABT-414 will be administered by intravenous infusion.
Site Reference ID/Investigator# 90333
Scottsdale, Arizona, United States
Site Reference ID/Investigator# 83156
Chicago, Illinois, United States
Site Reference ID/Investigator# 117516
Boston, Massachusetts, United States
Site Reference ID/Investigator# 83154
Boston, Massachusetts, United States
Phase 1 - Safety (Number of subjects with adverse events and/or dose limiting toxicities)
Evaluation of vital signs, clinical lab testing, adverse event monitoring, physical exam and electrocardiogram (ECG) (periodic) under different dosing schedules, drug infusion times, and manufacturing processes.
Time frame: Every 1-3 weeks for an average of 20 weeks
Phase 1 - Pharmacokinetic profile
Cmax, Cmin, and half-life
Time frame: Multiple timepoints Week 1 and Week 7
Phase 2 - Efficacy
Objective response per Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST)
Time frame: Every 6-9 weeks for an average of 20 weeks
Phase 2- Safety (Scheduled study visits occurring on average every 3 weeks)
Evaluation of vital signs, clinical lab testing, and adverse event monitoring, physical exam, and electrocardiogram (periodic)
Time frame: Followed on average every 3 weeks for approximately 20 weeks
Phase 2- Pharmacokinetic profile
Cmax, Cmin, and half-life
Time frame: Multiple timepoints Week 1
Phase 1&2 - QT assessment
Triplicate electrocardiograms
Time frame: Week 1
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Site Reference ID/Investigator# 83155
San Antonio, Texas, United States
Site Reference ID/Investigator# 89035
Ottawa, Canada