A Phase 1 interventional study of ABT-414 in Squamous Cell Tumors, sponsored by AbbVie (prior sponsor, Abbott). Completed at 6 sites in 2 countries. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2017-11-20.
Sponsored by AbbVie (prior sponsor, Abbott) · Phase 1, Interventional, and Treatment
A study of ABT-414 in subjects with solid tumors.
134 studies on the registry are indexed under Neoplasms, Squamous Cell; 14 are open to participants now.
This study's enrollment of 57 is above the median of 43 across 113 interventional studies indexed under Neoplasms, Squamous Cell.
Browse Neoplasms, Squamous Cell studies →AbbVie (prior sponsor, Abbott) is the lead sponsor of 215 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Subjects with solid tumors (Phase 1) and squamous non-small cell lung cancer (NSCLC) (Phase 2)
Drug: ABT-414
ABT-414 will be administered by intravenous infusion.
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
This study is completed, as verified in Feb 2016. You cannot join it, but the record below documents what was studied.
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AbbVie (prior sponsor, Abbott)