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NCT01017731 · ClinicalTrials.gov registry record · Phase 2
Study of Ramucirumab (IMC-1121B) Therapy and Corrected QT (QTc) Interval Changes
A Phase 2 study, sponsored by Eli Lilly and Company.
- Completed
- Registry status
- Phase 2
- Development phase
- 68
- Enrollment target
NCT01017731: Completed Phase 2 study, sponsored by Eli Lilly and Company.
NCT01017731 is a Phase 2 study that has completed, run by Eli Lilly and Company. The registered enrollment target is 68 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (49% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01017731, a Phase 2 study, has completed, sponsored by Eli Lilly and Company.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 68 participants
- Enrollment target
Study Summary
The purpose of this study is to determine if Ramucirumab (IMC-1121B) causes prolongation of the QT/QTc interval in participants with advanced cancer.
Primary Outcome
All electrocardiogram (ECG) tests were performed in triplicate prior to ramucirumab treatment. QT is the interval between the Q and T waves and QTc is the QT corrected for heart rate using Fridericia's formula: QTc = QT/RR\^0.33 where RR is the interval between 2 R waves. Each participant's mean QT/QTc value was calculated for each ECG test during Cycle 3 and compared to his/her mean pretreatment QT/QTc value. The greatest change from baseline during Cycle 3 was reported. QTc prolongation is def
Interventions
- DRUG Diphenhydramine
- DRUG Moxifloxacin
- BIOLOGICAL IMC-1121B
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 68 participants |
| Start Date | 2009-11 |
| Est. Completion | 2014-05 |
| Phase | Phase 2 |
What the finished NCT01017731 record still lists
NCT01017731 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 68 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (49% lower).
The record links to 0 conditions, and to 3 interventions - of which Diphenhydramine is the first listed.
NCT01017731 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01017731 about?
NCT01017731 is a clinical study titled "Study of Ramucirumab (IMC-1121B) Therapy and Corrected QT (QTc) Interval Changes". The purpose of this study is to determine if Ramucirumab (IMC-1121B) causes prolongation of the QT/QTc interval in participants with advanced cancer.
What is the current status of trial NCT01017731?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 68 participants. The study started on 2009-11. Estimated completion is 2014-05.
What interventions are being tested in trial NCT01017731?
The interventions under investigation include: Diphenhydramine (DRUG), Moxifloxacin (DRUG), IMC-1121B (BIOLOGICAL).
Who is sponsoring clinical trial NCT01017731?
This trial is sponsored by Eli Lilly and Company, which has 1,341 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01017731's enrollment target sits among peer trials
68 967th of 2000 higher than 1,027 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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