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NCT01119456 · ClinicalTrials.gov registry record · Phase 1
A Study of IMC-RON8 in Advanced Solid Tumors
A Phase 1 study, sponsored by Eli Lilly and Company.
- Completed
- Registry status
- Phase 1
- Development phase
- 39
- Enrollment target
NCT01119456: Completed Phase 1 study, sponsored by Eli Lilly and Company.
NCT01119456 is a Phase 1 study that has completed, run by Eli Lilly and Company. The registered enrollment target is 39 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (35% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01119456, a Phase 1 study, has completed, sponsored by Eli Lilly and Company.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 39 participants
- Enrollment target
Study Summary
A dose escalation study to determine the maximum tolerated dose of IMC-RON8 in participants with solid tumors. Participants can either be dosed once a week, or once every other week.
Primary Outcome
The MTD was the previous dose level to that in which 2 of 6 participants experienced dose-limiting toxicities (DLTs). DLTs were defined as any of the following events: Grade 4 neutropenia lasting \>7 days; any Grade 3 or 4 neutropenia complicated by fever ≥38.5 degrees Celsius or infection, Grade 4 thrombocytopenia, or Grade 3 thrombocytopenia complicated by hemorrhage; Grade 3 hepatic toxicity; or any Grade 3 or 4 nonhematologic toxicity (excluding alopecia, fatigue, anorexia, nausea, and vomit
Interventions
- BIOLOGICAL IMC-RON8
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 39 participants |
| Start Date | 2010-05 |
| Est. Completion | 2013-11 |
| Phase | Phase 1 |
What the finished NCT01119456 record still lists
NCT01119456 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 39 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (35% lower).
The record links to 0 conditions, and to 1 intervention - of which IMC-RON8 is the first listed.
NCT01119456 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01119456 about?
NCT01119456 is a clinical study titled "A Study of IMC-RON8 in Advanced Solid Tumors". A dose escalation study to determine the maximum tolerated dose of IMC-RON8 in participants with solid tumors. Participants can either be dosed once a week, or once every other week.
What is the current status of trial NCT01119456?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 39 participants. The study started on 2010-05. Estimated completion is 2013-11.
What interventions are being tested in trial NCT01119456?
The interventions under investigation include: IMC-RON8 (BIOLOGICAL).
Who is sponsoring clinical trial NCT01119456?
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 NCT01119456's enrollment target sits among peer trials
39 1191st of 2000 higher than 804 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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