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NCT01634555 · ClinicalTrials.gov registry record · Phase 2
A Study to Assess the Pharmacokinetics of Ramucirumab (IMC-1121B) in Combination With FOLFIRI
A Phase 2 study, sponsored by Eli Lilly and Company.
- Completed
- Registry status
- Phase 2
- Development phase
- 29
- Enrollment target
NCT01634555: Completed Phase 2 study, sponsored by Eli Lilly and Company.
NCT01634555 is a Phase 2 study that has completed, run by Eli Lilly and Company. The registered enrollment target is 29 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (78% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01634555, a Phase 2 study, has completed, sponsored by Eli Lilly and Company.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 29 participants
- Enrollment target
Study Summary
The purpose of this study is to assess the effect of concomitant ramucirumab (IMC-1121B) on the pharmacokinetics of irinotecan and its metabolite SN-38 when coadministered with folinic acid and 5-fluorouracil, in participants with advanced malignant solid tumors resistant to standard therapy or for which no standard therapy is available.
Primary Outcome
Dose-normalized AUC(0-∞) was calculated from AUC(0-∞) divided by the dose. Data presented are Geometric Least Squares (Geo LS) means. Geo LS means were adjusted for cycle, participant and random error.
Interventions
- DRUG Irinotecan
- DRUG 5-Fluorouracil
- DRUG Folinic acid
- BIOLOGICAL Ramucirumab (IMC-1121B)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 29 participants |
| Start Date | 2012-10 |
| Est. Completion | 2018-02 |
| Phase | Phase 2 |
What the finished NCT01634555 record still lists
NCT01634555 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 29 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (78% lower).
The record links to 0 conditions, and to 4 interventions - of which Irinotecan is the first listed.
NCT01634555 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01634555 about?
NCT01634555 is a clinical study titled "A Study to Assess the Pharmacokinetics of Ramucirumab (IMC-1121B) in Combination With FOLFIRI". The purpose of this study is to assess the effect of concomitant ramucirumab (IMC-1121B) on the pharmacokinetics of irinotecan and its metabolite SN-38 when coadministered with folinic acid and 5-fluorouracil, in participants with advanced malignant solid tumors resistant to standard therapy or for ...
What is the current status of trial NCT01634555?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 29 participants. The study started on 2012-10. Estimated completion is 2018-02.
What interventions are being tested in trial NCT01634555?
The interventions under investigation include: Irinotecan (DRUG), 5-Fluorouracil (DRUG), Folinic acid (DRUG), Ramucirumab (IMC-1121B) (BIOLOGICAL).
Who is sponsoring clinical trial NCT01634555?
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 NCT01634555's enrollment target sits among peer trials
29 1669th of 2000 higher than 324 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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