NCT00832117

Phase I Combination Ixabepilone + Cisplatin

Phase 1 Study of Ixabepilone in Combination With Cisplatin in Subjects With Advanced Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: R-Pharm · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the highest dose of ixabepilone that can be given safely with cisplatin without causing severe or life-threatening side effects and for some patients with non-small cell lung cancer, the effects (good or bad) on your cancer will also be studied

Conditions

• Non Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Ixabepilone	Escalation: Solution, intravenous (IV), 32-40 mg/m2, every 3 weeks, approximately 6 months
DRUG	Cisplatin	Escalation: Solution, IV, 60-100 mg/m2, every 3 weeks, approximately 6 months
DRUG	Ixabepilone	Expansion: Solution, IV, 32 mg/m2, every 3 weeks, approximately 6 months
DRUG	Cisplatin	Expansion: Solution, IV, 60-80 mg/m2, every 3 weeks, approximately 6 months

Timeline

• Start date: 2009-05-01
• Primary completion: 2011-01-01
• Completion: 2011-01-01
• First posted: 2009-01-29
• Last updated: 2020-10-28
• Results posted: 2012-03-27

Locations

7 sites across 2 countries: United States, Italy