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NCT00920907 · ClinicalTrials.gov registry record · Phase 1
Comparison of Ipilimumab Manufactured by 2 Different Processes in Participants With Advanced Melanoma
A Phase 1 study, sponsored by Bristol-Myers Squibb.
- Completed
- Registry status
- Phase 1
- Development phase
- 99
- Enrollment target
NCT00920907: Completed Phase 1 study, sponsored by Bristol-Myers Squibb.
NCT00920907 is a Phase 1 study that has completed, run by Bristol-Myers Squibb. The registered enrollment target is 99 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (65% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00920907, a Phase 1 study, has completed, sponsored by Bristol-Myers Squibb.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 99 participants
- Enrollment target
Study Summary
The purpose of this clinical research study is to compare pharmacokinetics of ipilimumab manufactured by two different processes
Primary Outcome
Single-dose Pharmacokinetic (PK) parameters of ipilimumab were derived from serum concentration versus time data. Cmax was measured from first dose to end of the induction period (4 doses) as micrograms per milliliter (μg/mL). Samples were obtained at 0 hour (predose) on Days 1, 2, 3, 4, and Weeks 2, 3, 4, 7, and 10; Day 1, samples were also obtained 1 h 30 minutes (min), 2 h, 2 h 30 min, 3 h 30 min, 4 h 30 min, and 6 h post dose. In calculating PK parameters, predose concentrations and concentr
Interventions
- BIOLOGICAL Ipilimumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 99 participants |
| Start Date | 2009-08 |
| Est. Completion | 2012-10 |
| Phase | Phase 1 |
What the finished NCT00920907 record still lists
NCT00920907 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 99 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (65% higher).
The record links to 0 conditions, and to 1 intervention - of which Ipilimumab is the first listed.
NCT00920907 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00920907 about?
NCT00920907 is a clinical study titled "Comparison of Ipilimumab Manufactured by 2 Different Processes in Participants With Advanced Melanoma". The purpose of this clinical research study is to compare pharmacokinetics of ipilimumab manufactured by two different processes
What is the current status of trial NCT00920907?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 99 participants. The study started on 2009-08. Estimated completion is 2012-10.
What interventions are being tested in trial NCT00920907?
The interventions under investigation include: Ipilimumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT00920907?
This trial is sponsored by Bristol-Myers Squibb, which has 1,025 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00920907's enrollment target sits among peer trials
99 590th of 2000 higher than 1,409 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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