Comparison of Ipilimumab Manufactured by 2 Different Processes in Participants With Advanced Melanoma

Part of paid clinical trials in Los Angeles, California.

Sponsor
Bristol-Myers Squibb
Study ID
NCT00920907
Phase
PHASE1
Status
Completed

Conditions

  • Advanced Melanoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ipilimumab — BIOLOGICAL
    Solution, Intravenous, 10 mg/kg, Every 3 weeks (up to 4 doses) in induction phase, every 12 weeks in maintenance phase, 48 weeks

Study Details

The purpose of this clinical research study is to compare pharmacokinetics of ipilimumab manufactured by two different processes

Key Dates

Start date
Aug 31, 2009
Status verified
May 2014
Primary completion
Apr 30, 2010
Completion
Oct 31, 2012

Study Design

Enrollment
99 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Ipilimumab (Process B)
    Reference
  • Experimental: Ipilimumab (Process C)
    Test

Primary Outcome Measure

Maximum Observed Serum Concentration (Cmax) of Ipilimumab Manufactured by Process C Relative to the Cmax of Ipilimumab Manufactured by Process B - Evaluable Pharmacokinetic Population [ Time Frame: Day 1 to Day 84 ]

Locations (7)

FacilityCityStateZIPSite coordinators
The Angeles Clinic & Research Inst.Los AngelesCalifornia90025-
California Pacific Medical CenterSan FranciscoCalifornia94115-
H Lee Moffitt Cancer CenterTampaFlorida33612-9416-
Memorial Sloan Kettering Cancer CenterNew YorkNew York11065-
Carolinas Medical CenterCharlotteNorth Carolina28204-
St Luke'S Hospital And Health NetworkBethlehemPennsylvania18015-
Seattle Cancer Care AllianceSeattleWashington98109-1023-

Find similar trials in Los Angeles, CA

By research site
The Angeles Clinic & Research Inst.· Los Angeles, CACalifornia Pacific Medical Center· San Francisco, CAH Lee Moffitt Cancer Center· Tampa, FLMemorial Sloan Kettering Cancer Center· New York, NYCarolinas Medical Center· Charlotte, NCSt Luke'S Hospital And Health Network· Bethlehem, PA

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