NCT00274443

An Open Label Study in Patients With Advanced NSCLC With ABI-007(Abraxane) in Combination With Carboplatin

An Open -Label, Phase II Trial of Increasing Doses of ABI-007 and Carboplatin in Patients With Advanced Non Small Cell Lung Cancer (NSCLC)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 250 (actual)
• Sponsor: Celgene · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label dose escalation trial using ABI-007 plus carboplatin.

Detailed description

This is a multicenter study conducted at study sites in Russia and the Ukraine where various doses of ABI-007 (Abraxane) will be given in combination with carboplatin to patients with non-small cell lung cancer to determine the recommended dose and schedule for this combination therapy for Phase III trials. The primary objective of this study is to obtain preliminary information on the antitumor activity and adverse events of ABI-007 in combination with carboplatin.

Conditions

• Non-Small Cell Lung Cancer (NSCLC)

Interventions

Type	Name	Description
DRUG	ABI-007 (Abraxane) and Carboplatin	ABI-007 plus Carboplatin will be administered intravenously over 30 minutes in cycles of 3 weeks

Timeline

• Start date: 2005-03-01
• Primary completion: 2007-06-01
• Completion: 2007-06-01
• First posted: 2006-01-11
• Last updated: 2019-11-12

Locations

1 site across 1 country: Russia