Trials / Completed
CompletedNCT00920907
Comparison of Ipilimumab Manufactured by 2 Different Processes in Participants With Advanced Melanoma
A Randomized, Parallel, Open-Label Study to Compare the Pharmacokinetics of Ipilimumab (BMS-734016) Process C to Process B in Subjects With Advanced Melanoma
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 99 (actual)
- Sponsor
- Bristol-Myers Squibb · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this clinical research study is to compare pharmacokinetics of ipilimumab manufactured by two different processes
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Ipilimumab | Solution, Intravenous, 10 mg/kg, Every 3 weeks (up to 4 doses) in induction phase, every 12 weeks in maintenance phase, 48 weeks |
Timeline
- Start date
- 2009-08-01
- Primary completion
- 2010-04-01
- Completion
- 2012-10-01
- First posted
- 2009-06-15
- Last updated
- 2014-06-20
- Results posted
- 2014-03-06
Locations
7 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00920907. Inclusion in this directory is not an endorsement.