A Study of Necitumumab Monotherapy and the QT/QTc Interval in Patient With Advanced Solid Tumors
Part of paid clinical trials in Ann Arbor, Michigan.
- Sponsor
- Eli Lilly and Company
- Study ID
- NCT01624467
- Phase
- PHASE2
- Status
- Completed
Conditions
- Solid Tumors
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Necitumumab — BIOLOGICAL800 mg necitumumab, administered once per week IV
Study Details
The purpose of this study is to determine whether treatment with necitumumab monotherapy affects the QT/QTc interval among participants with advanced solid tumors refractory to standard treatment or for which no standard treatment is available.
Key Dates
- Start date
- Aug 31, 2012
- Status verified
- Jun 2016
- Primary completion
- May 31, 2014
- Completion
- Jun 30, 2015
Study Design
- Enrollment
- 75 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Necitumumab800 mg necitumumab, administered once per week as an intravenous infusion (IV)
Primary Outcome Measure
Change From Time-Matched Baseline in QT Interval Corrected for Heart Rate (QTc) [ Time Frame: Baseline, Cycle1 Day 1, 8,15, 22, 29, and 36: Pre-infusion, End of Infusion, 1 Hour (hr), 2, 4, 24, 48, 72 hr Post Infusion ]
Locations (8)
Find similar trials in Ann Arbor, MI
By research site
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.· Ann Arbor, MIFor additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.· Detroit, MIFor additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.· Las Vegas, NVFor additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.· New Brunswick, NJFor additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.· Huntersville, NCFor additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.· Cleveland, OH
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