A Study of ABT-414 in Subjects With Solid Tumors | NCT01741727 | Trialant

A Study of ABT-414 in Subjects With Solid Tumors | NCT01741727 | Trialant

Arms/Interventions Module

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	Every 1-3 weeks for an average of 20 weeks
Phase 1 - Pharmacokinetic profile	Cmax, Cmin, and half-life	Multiple timepoints Week 1 and Week 7
Phase 2 - Efficacy	Objective response per Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST)	Every 6-9 weeks for an average of 20 weeks

Secondary Outcomes

Measure	Description	Time Frame
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)	Followed on average every 3 weeks for approximately 20 weeks
Phase 2- Pharmacokinetic profile

Contacts/Locations Module

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
28349167	Result	Munasinghe WP, Mittapalli RK, Li H, Hoffman DM, Holen KD, Menon RM, Xiong H. Evaluation of the effect of the EGFR antibody-drug conjugate ABT-414 on QT interval prolongation in patients with advanced solid tumors likely to over-express EGFR. Cancer Chemother Pharmacol. 2017 May;79(5):915-922. doi: 10.1007/s00280-017-3284-y. Epub 2017 Mar 27.