NCT00796991

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

A Randomized, Parallel, 3-arm Study to Characterize the Effect of Ipilimumab + Chemotherapy in Patients With Untreated Advanced Melanoma

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 72 (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 learn the pharmacokinetics of Ipilimumab when combined with Paclitaxel/Carboplatin or Dacarbazine

Conditions

• Advanced Melanoma

Interventions

Type	Name	Description
DRUG	Ipilimumab	Solution, intravenous, 10mg/kg, every 3 weeks in the induction phase, up to 4 doses in the induction phase, 48 weeks
DRUG	Carboplatin	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
DRUG	Paclitaxel	Solution, intravenous, 175 mg/m2, every 3 weeks in the induction phase, up to 8 doses in the induction phase, 48 weeks
DRUG	Dacarbazine	Solution, intravenous, 850 mg/m2, every 3 weeks in the induction phase, up to 8 doses in the induction phase, 48 weeks

Timeline

• Start date: 2009-02-01
• Primary completion: 2009-11-01
• Completion: 2012-10-01
• First posted: 2008-11-24
• Last updated: 2014-01-06
• Results posted: 2014-01-06

Locations

4 sites across 1 country: United States