Drug-Drug Interaction - 3 Arm - Carboplatin/Paclitaxel, Dacarbazine

Part of paid clinical trials in Los Angeles, California.

Sponsor
Bristol-Myers Squibb
Study ID
NCT00796991
Phase
PHASE1
Status
Completed

Conditions

  • Advanced Melanoma

Eligibility Criteria

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

Interventions

  • Ipilimumab — DRUG
    Solution, intravenous, 10mg/kg, every 3 weeks in the induction phase, up to 4 doses in the induction phase, 48 weeks
  • Carboplatin — DRUG
    Solution, intravenous, Area Under the Concentration Time Curve=6, every 3 weeks in the induction phase, up to 8 doses in the induction phase, 48 weeks
  • Paclitaxel — DRUG
    Solution, intravenous, 175 mg/m2, every 3 weeks in the induction phase, up to 8 doses in the induction phase, 48 weeks
  • Dacarbazine — DRUG
    Solution, intravenous, 850 mg/m2, every 3 weeks in the induction phase, up to 8 doses in the induction phase, 48 weeks

Study Details

The purpose of this clinical research study is to learn the pharmacokinetics of Ipilimumab when combined with Paclitaxel/Carboplatin or Dacarbazine

Key Dates

Start date
Feb 28, 2009
Status verified
Dec 2013
Primary completion
Nov 30, 2009
Completion
Oct 31, 2012

Study Design

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

Arms

  • Active Comparator: Arm A
  • Active Comparator: Arm B
  • Active Comparator: Arm C

Primary Outcome Measure

Pharmacokinetic Parameter Maximum Observed Serum Concentration (Cmax) for Ipilimumab, Paclitaxel, Dacarbazine and the Active Metabolite for Dacarbazine, 5-aminoimidazole-4carboxamide (AIC)- Pharmacokinetic Analysis Population [ Time Frame: Day 1 (0 h) to Day 43 ]

Locations (4)

FacilityCityStateZIPSite coordinators
The Angeles Clinic & Research Inst.Los AngelesCalifornia90025-
H Lee Moffit Cancer Cnt And Res InstTampaFlorida33612-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10021-
Blumenthal Cancer Center, Carolinas Medical CenterCharlotteNorth Carolina28204-

Find similar trials in Los Angeles, CA

By research site
The Angeles Clinic & Research Inst.· Los Angeles, CAH Lee Moffit Cancer Cnt And Res Inst· Tampa, FLMemorial Sloan Kettering Cancer Center· New York, NYBlumenthal Cancer Center, Carolinas Medical Center· Charlotte, NC

Related Studies