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NCT01515306 · ClinicalTrials.gov registry record · Phase 2
A Study of Ramucirumab (IMC-1121B) and Paclitaxel in Participants With Solid Tumors
A Phase 2 study of Malignant Solid Tumor, sponsored by Eli Lilly and Company.
- Completed
- Registry status
- Phase 2
- Development phase
- 48
- Enrollment target
- 6
- Study locations
NCT01515306: Completed Phase 2 study of Malignant Solid Tumor, sponsored by Eli Lilly and Company.
NCT01515306 is a Phase 2 study of Malignant Solid Tumor that has completed, run by Eli Lilly and Company. The registered enrollment target is 48 participants, below the 162-participant average among 8 other Malignant Solid Tumor trials with a reported enrollment target (70% lower). The trial reports 6 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01515306, a Phase 2 study of Malignant Solid Tumor, has completed, sponsored by Eli Lilly and Company.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 48 participants
- Enrollment target
- 6
- Study locations
Study Summary
The purpose of this study is to investigate whether there are no clinically significant pharmacokinetic effects of concomitant ramucirumab (IMC-1121B) on paclitaxel by investigating the pharmacokinetics (PK) of each in participants with advanced malignant solid tumors. Part A of this study will investigate the potential of concomitant ramucirumab (IMC-1121B) to affect the pharmacokinetics of paclitaxel. Part B of this study will investigate the pharmacokinetics of ramucirumab (IMC-1121B) as monotherapy.
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.
Conditions Studied
Interventions
- DRUG paclitaxel
- BIOLOGICAL ramucirumab (IMC-1121B)
Study Locations (6)
Michigan
- ImClone Investigational Site - Ann Arbor
- ImClone Investigational Site - Detroit
New Jersey
- ImClone Investigational Site - New Brunswick
Ohio
- ImClone Investigational Site - Cleveland
Pennsylvania
- ImClone Investigational Site - Philadelphia
Washington
- ImClone Investigational Site - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2012-07-19 |
| Est. Completion | 2021-02-22 |
| Phase | Phase 2 |
What the finished NCT01515306 record still lists
NCT01515306 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 162-participant average among 8 other Malignant Solid Tumor trials with a reported enrollment target (70% lower).
The record links to 1 condition, with Malignant Solid Tumor appearing as the primary indexed condition, and to 2 interventions - of which paclitaxel is the first listed.
NCT01515306 lists 6 locations in 5 states (Michigan, New Jersey, Ohio).
Frequently Asked Questions
What is clinical trial NCT01515306 about?
NCT01515306 is a clinical study titled "A Study of Ramucirumab (IMC-1121B) and Paclitaxel in Participants With Solid Tumors". The purpose of this study is to investigate whether there are no clinically significant pharmacokinetic effects of concomitant ramucirumab (IMC-1121B) on paclitaxel by investigating the pharmacokinetics (PK) of each in participants with advanced malignant solid tumors. Part A of this study will inv...
What is the current status of trial NCT01515306?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 48 participants. The study started on 2012-07-19. Estimated completion is 2021-02-22.
What conditions does trial NCT01515306 study?
This clinical trial studies the following conditions: Malignant Solid Tumor.
What interventions are being tested in trial NCT01515306?
The interventions under investigation include: paclitaxel (DRUG), ramucirumab (IMC-1121B) (BIOLOGICAL).
Who is sponsoring clinical trial NCT01515306?
This trial is sponsored by Eli Lilly and Company, which has 1,341 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01515306 being conducted?
This trial has 6 study locations across Michigan, New Jersey, Ohio, Pennsylvania, Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01515306's enrollment target sits among peer trials
48 6th of 8 higher than 3 of 8 other Malignant Solid Tumor trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Malignant Solid Tumor 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.
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